Electro-convulsive therapy

[Kazimiera]

What is ECT?

Electroconvulsive therapy (ECT) is a procedure in which a brief application of electric stimulus is used to produce a generalized seizure. It is not known how or why ECT works or what the electrically stimulated seizure does to the brain. In the U.S. during the 1940’s and 50’s, the treatment was administered mostly to people with severe mental illnesses. During the last few decades, researchers have been attempting to identify the effectiveness of ECT, to learn how and why it works, to understand its risks and adverse side effects, and to determine the best treatment technique. Today, ECT is administered to an estimated 100,000 people a year, primarily in general hospital psychiatric units and in psychiatric hospitals. It is generally used in treating patients with severe depression, acute mania, and certain schizophrenic syndromes. ECT is also used with some suicidal patients, who cannot wait for antidepressant medication to take effect.

How is it administered?

ECT treatment is generally administered in the morning, before breakfast. Prior to the actual treatment, the patient is given general anesthesia and a muscle relaxant. Electrodes are then attached to the patients scalp and an electric current is applied which causes a brief convulsion. Minutes later, the patient awakens confused and without memory of events surrounding the treatment. This treatment is usually repeated three times a week for approximately one month. The number of treatments varies from six to twelve. It is often recommended that the patient maintain a regimen of medication, after the ECT treatments, to reduce the chance of relapse.

To maximize the benefits of ECT, it is crucial that the patient’s illness be accurately diagnosed and that the risks and adverse side effects be weighed against those of alternative treatments. The risks and side effects involved with the use ECT are related to the misuse of equipment, ill-trained staff, incorrect methods of administration, persistent memory loss, and transient post-treatment confusion.

Why is ECT so controversial?

After 60 years of use, ECT is still the most controversial psychiatric treatment. Much of the controversy surrounding ECT revolves around its effectiveness vs. the side effects, the objectivity of ECT experts, and the recent increase in ECT as a quick and easy solution, instead of long-term psychotherapy or hospitalization.

Because of the concern about permanent memory loss and confusion related to ECT treatment, some researchers recommend that the treatment only be used as a last resort. It is also unclear whether or not ECT is effective. In some cases, the numbers are extremely favorable, citing 80 percent improvement in severely depressed patients, after ECT. However, other studies indicate that the relapse is high, even for patients who take medication after ECT. Some researchers insist that no study proves that ECT is effective for more than four weeks.

During the last decade, the “typical” ECT patient has changed from low-income males under 40, to middle-income women over 65. This coincides with changing demographics. The increase in the elderly population and Medicare, and the push by insurance companies to provide fast, “medical” treatment rather than talk therapy. Unfortunately, concerns have been raised concerning inappropriate and even dangerous treatment of elderly patients with heart conditions, and the administration of ECT without proper patient consent.

Is ECT an option?

The patient and physician should discuss all options available before deciding on any treatment. If ECT is recommended, the patient should be given a complete medical examination including a history, physical, neurological examination, EKG and laboratory test. Medications need to be noted and monitored closely, as should cardiac conditions and hypertension. The patient and family should be educated and informed about the procedure via videos, written material, discussion, and any other means available before a written consent is signed.

The procedure should be administered by trained health professionals with experience in ECT administration as well as a specifically trained and certified anesthesiologist to administer the anesthesia. The seizure initiated by the electrical stimulus varies from person to person and should be monitored carefully by the administration team. Monitoring should be done by an EEG or “cuff” technique.

The nature of ECT, its history of abuse, unfavorable medical and media reports, and testimony from former patients all contribute to the debate surrounding its use. Research should continue, and techniques should be refined to maximize the efficacy and minimize the risks and side effects resulting from ECT.

Who might benefit from ECT?

According to the American Psychiatric Association, ECT can be beneficial in the following situations:

When a need exists for rapid treatment response, such as in pregnancy
When a patient refuses food and that leads to nutritional deficiencies
When a patient's depression is resistant to antidepressant therapy
When other medical ailments prevent the use of antidepressant medication
When the patient is in a catatonic stupor
When the depression is accompanied by psychotic features
When treating bipolar disorder, including both mania and depression
When treating mania
When treating patients who have a severe risk of suicide
When treating patients who have had a previous response to ECT
When treating patients with psychotic depression or psychotic mania
When treating patients with major depression
When treating schizophrenia

[Kazimiera]

Risk and side effects of ECT

Key risks are defined as substantial risks of device use that could significantly influence the risk/benefit profile of the device. Mitigating factors may potentially serve as regulatory controls to adequately reduce the risk of device use such that a reasonable assurance of safety and effectiveness can be demonstrated for the device.

Like the determination of potentially significant adverse events discussed in the safety review, the identification of key risks is based on similar criteria, that is, they are substantiated by a comprehensive review of all sources of data, there is sufficient evidence of significant frequency and severity, and there’s evidence of being associated with ECT device use. [...]

The key risks of ECT are presented in this slide and reorganized into three different main categories.

The first category, medical and physical risks includes adverse reaction to anesthetic agents and neuromuscular blocking agents, alterations in blood pressure, cardiovascular complications, death, dental and oral trauma, pain and discomfort, physical trauma, prolonged seizures, pulmonary complications, skin burns, and stroke. The other two main categories include cognitive and memory dysfunction, and device malfunction. [...]

Again, here’s the list of proposed key risks. The Panel will be asked if this is a complete and accurate list of the key risks presented by ECT and asked to comment on whether you disagree with the inclusion of any of these risks or whether you believe any other risks are among the key risks presented by ECT.


Adverse reactions to anesthesia are rare but potentially severe complications associated with ECT. These reactions are related to the use of anesthetic agents and neuromuscular blocking agents to which patients may have rare but potentially severe reactions. Potential mitigating factors may consist of pre-ECT assessment, including pertinent medical and surgical history, family history of reaction to anesthetic agents, physical exam, as well as appropriate procedure monitoring and clinical management to any reaction that may arise.

Alterations in blood pressure are common but typically benign complications associated ECT. Hypertension as well as hypotension may be associated with ECT treatment. Potential mitigating factors include pre-ECT assessment of medical, particularly cardiovascular status, appropriate procedure monitoring, and clinical management.

Cardiovascular complications are uncommon but potentially severe complications of ECT treatment. They most commonly include arrhythmias and/or ischemia. Cardiovascular complications are one of the most frequent causes of morbidity and mortality associated with ECT. Potential mitigating factors for cardiovascular complications include pre-ECT assessment which may include blood pressure assessment, pre-ECT electrocardiogram, echocardiogram or Holter monitoring, appropriate procedure monitoring, and clinical management.

Death is a rare but severe outcome of ECT treatment. It is a result of various complications of ECT such as reactions to anesthesia, cardiovascular complications, pulmonary complications, or stroke. Potential mitigating factors include those proposed for each of these key risks.

Dental and oral trauma including dental fractures, dislocations, lacerations, and prosthetic damage are uncommon complications of ECT and are generally of mild to moderate severity. Potential mitigating factors may include pre-ECT dental assessment, removal of prostheses, as well as the use of mouth protection or bite blocks during the procedure.

Pain and discomfort are common but generally mild to moderate complications of ECT. They are typically treated with the use of as-needed analgesic medication.

Physical trauma associated with ECT, they include fractures and soft tissue injury. Physical trauma usually occurs as a consequence of significant muscle contraction during the treatment. Though more prevalent in previous years of ECT use, in current practice, this key risk is uncommon. Potential mitigating factors to prevent or reduce the severity of physical trauma include the use of general anesthetic agents and neuromuscular blocking agents. 189

Prolonged seizures are an uncommon and moderate to severe complication of ECT. Status epilepticus may ensue if prolonged seizures are not properly treated. Potential mitigating factors include an appropriate pre-ECT neurological assessment as well as EEG monitoring during the procedure and the availability of rapid treatment of prolonged seizures should they occur.

Pulmonary complications, such as prolonged apnea or aspiration, are rare but potentially severe complications of ECT. With cardiovascular complications, they represent one of the most common causes of morbidity and mortality associated with ECT. Potential mitigating factors include appropriate pre-ECT assessment of pulmonary function, pre- ECT tests such as chest x-ray and pulmonary function test, and appropriate monitoring and clinical management before, during, and after the procedure.

Skin burns are uncommon and typically mild complications of ECT. They most commonly occur when there’s poor contact of the electrode with the skin surface resulting in high impedance in the electrical circuit. Skin burns may be mitigated by proper skin preparation, electrode contact, including the use of conductivity gel.

Stroke is a rare and potentially severe complication that may be associated with ECT. Potential mitigating factors include pre-ECT assessment of risk factors for stroke, including possible neuroimaging or cardiovascular and neurovascular assessment when appropriate, appropriate procedure monitoring, and clinical management during the treatment.

The issue of inadequate informed consent processes and/or forced treatment has been raised in the public docket, in the MAUDE database, and in the published literature. Critics of the informed consent process claim that if individuals are inadequately or inaccurately informed of the risks of ECT, the risk/benefit assessment is altered.

One potential mitigating factor for inadequate consent is the requirement of a more rigorous informed consent process. Such a process would help to ensure that the patient is making a fully informed decision about receiving treatment. The process would consist of outlining a more rigorous consent process in the user labeling of the device that would require the use of an additional checklist in addition to standard written informed consent procedure. This checklist would contain all known risks of device usage, the likelihood of occurrence, and the potential severity.

During the process, the treating physician and patient would be required to review each item with both parties signing off to acknowledge discussion of the item. This checklist could then be kept with the standard written informed consent documentation, and the criteria for patient capacity to consent to treatment and perform the acceptance of risk through this process would remain unchanged. Acceptance of risk checklist may be a useful special control for addressing the risks of ECT device use. Within FDA, there’s precedence for requiring such additional informed consent requirements.

Please keep this discussion of key risks and potential mitigating factors in mind in your deliberations of the following question regarding whether the medical and physical risks of ECT can be adequately mitigated.

Aside from effects in the brain, the general physical risks of ECT are similar to those of brief general anesthesia; the United States' Surgeon General's report says that there are "no absolute health contraindications" to its use.

Some patients experience muscle soreness after ECT. This is due to the muscle relaxants given during the procedure and rarely due to muscle activity

Effects on memory

It is the purported effects of ECT on long-term memory that give rise to much of the concern surrounding its use. However, the vast majority of these effects are short lived.

Memory loss and confusion are more pronounced with bilateral electrode placement rather than unilateral, and with outdated sine-wave rather than brief-pulse currents. The vast majority of modern treatment uses brief pulse currents.

Retrograde amnesia is most marked for events occurring in the weeks or months before treatment, with one study showing that although some people lose memories from years prior to treatment, recovery of such memories was "virtually complete" by seven months post-treatment, with the only enduring loss being memories in the weeks and months prior to the treatment.

Anterograde memory loss is usually limited to the time of treatment itself or shortly afterwards. In the weeks and months following ECT these memory problems gradually improve, but some people have persistent losses, especially with bilateral ECT.

In 2000, American psychiatrist Sarah Lisanby and colleagues found that bilateral ECT left patients with more persistently impaired memory of public events as compared to RUL ECT.

Some studies have found that patients are often unaware of cognitive deficits induced by ECT. For example, in June 2008, a Duke University study.

Controversy over long-term effects on general cognition

According to prominent ECT researcher Harold Sackeim, "despite over fifty years of clinical use and ongoing controversy", until 2007 there had "never been a large-scale, prospective study of the cognitive effects of ECT."

Despite over fifty years of clinical use, Sackeim states that prior to 2001, "the field itself never really had an opportunity to have a discussion about patients who have complaints about long-term memory loss."

Sackeim says this was "almost a watershed moment for the field", and was the "first time ''publicly'' that the field itself said 'no' to the position that it can't happen."

In July 2007, a second study was published concluding that ECT routinely leads to chronic, substantial cognitive deficits, and the findings were not limited to any particular forms of ECT.

Based on his findings, Fink suggests that, "Instead of endorsing these reports as the direct consequence of ECT, especially in patients who have recovered from their depressive illness, lost their suicidal drive, and have improved social functioning, is it not more useful to accept the complaint as a somatoform disorder, explore the basis in the individual’s history and experience, and offer appropriate supportive treatment?"

For example, in June 2009, Portuguese researchers published a review on the safety and efficacy of ECT in an article entitled, ''Electroconvulsive Therapy: Myths and Evidences.'' He disagrees with the position that findings of chronic, global cognitive deficits should have no bearing on the risk-benefit ratio of ECT, and he believes it's important to address the "actual impact of these losses on the lives of individual patients."

In a section of his paper entitled ''Destroying Lives'', Dr. Breggin writes, "Even when these injured people can continue to function on a superficial social basis, they nonetheless suffer devastation of their identities due to the obliteration of key aspects of their personal lives.

The loss of the ability to retain and learn new material is not only humiliating and depressing but also disabling. Even when relatively subtle, these activities can disrupt routine activities of living." The study also reported, "There is no overlap between clinical and consumer studies on the question of benefit."

A recent opinion article by a neuropsychologist and a psychiatrist in Dublin suggests that ECT patients who experience cognitive problems following ECT should be offered some form of cognitive rehabilitation.

The authors say that the failure to attempt to rehabilitate patients may be partly responsible for the negative public image of ECT.

The article speculates on what aspects of such rehabilitation might be
useful, without reviewing the literature on its presence or absence.

Effects on brain structure

Considerable controversy exists over the effects of ECT on brain tissue despite the fact that a number of mental health associations, including the American Psychiatric Association, have concluded that there is no evidence that ECT causes structural brain damage.

A 1999 report by the United States Surgeon General states, "The fears that ECT causes gross structural brain pathology have not been supported by decades of methodologically sound research in both humans and animals".

A leading critic of ECT, psychiatrist Peter Breggin has published books and journalistic reviews of the literature purporting to show that ECT routinely causes brain damage as evidenced by a considerable list of studies in humans and animals.

In particular, Dr. Breggin asserts that animal and human autopsy studies have shown that ECT routinely causes ‘''widespread pinpoint hemorrhages and scattered cell death''.’

In a 2004 study designed to evaluate whether modern ECT techniques lead to identifiable brain damage, twelve monkeys underwent daily electroshock for six weeks under conditions meant to simulate human ECT; the animals were then sacrificed and their brains were compared to monkeys undergoing anesthesia alone.

According to the researchers, "None of the ECT-treated monkeys showed pathological findings."

There are recent animal studies that have documented significant brain damage after an electroshock series.

For example, in 2005, Russian researchers published a study entitled, ''Electroconvulsive Shock Induces Neuron Death in the Mouse Hippocampus: Correlation of Neurodegeneration with Convulsive Activity''.

In this study, the researchers found that after an electroshock series, there was a significant loss of neurons in parts of the brain and particularly in defined parts of the hippocampus where up to 10% of neurons were killed.

The researchers conclude that "the main cause of neuron death is convulsions evoked by electric shocks." In 2008, Portuguese researchers conducted a rat study aimed at answering the question of whether an electroshock series causes structural changes in vulnerable parts of the brain.

According to the authors, "This study answers positively the question of whether repeated administration of ECS seizures can cause brain lesions. Our data are consistent with findings from other animal models and from human studies in showing that neurons located in the entorhinal cortex and in the hilus of the dentate gyrus are particularly vulnerable to repeated seizures." However, they question the applicability of their own research with respect to Electroconvulsive therapy in humans: "An important caveat of our results is that it is unclear to what extent they are relevant to the use of electroconvulsive therapy in psychiatry, because the protocol employed in this study is different from that used clinically. Evidence from previous studies (Gombos et al., Vaidya et al., 1999) and from our pilot experiments indicates that treating rats either with five to ten widely spaced ECS (at 24- or 48-hr schedules) or with two stimulations only 2 hr apart does not lead to loss of hippocampal neurons".

Many expert proponents of ECT maintain that the procedure is safe and does not cause brain damage. Dr. Charles Kellner, a prominent ECT researcher and former chief editor of the ''Journal of ECT'' states in a recent published interview that, "There are a number of well-designed studies that show ECT does not cause brain damage and numerous reports of patients who have received a large number of treatments over their lifetime and have suffered no significant problems due to ECT." Dr. Kellner cites specifically to a study purporting to show an absence of cognitive impairment in eight subjects after more than 100 lifetime ECT treatments.

One of the authors of the cited study, Harold Sackeim, published a large-scale study less than a month after this interview concluding that the type of ECT used in the eight patients receiving the 100 lifetime treatments, bilateral sine wave, routinely leads to persistent, global cognitive deficits.

Suggested preparation for ECT during pregnancy includes a pelvic examination, discontinuation of nonessential anticholinergic medication, uterine tocodynamometry, intravenous hydration, and administration of a nonparticulate antacid.

During ECT, elevation of the pregnant woman's right hip, external fetal cardiac monitoring, intubation, and avoidance of excessive hyperventilation are recommended. the majority have found ECT to be safe. ECT is not performed on the fetus.


http://www.nmha.org/go/information/get-info/treatment/electroconvulsive-therapy-ect
http://www.webmd.com/depression/guide/electroconvulsive-therapy
http://psychcentral.com/lib/2011/risks-and-side-effects-of-ect/