Nonconvulsive Electrotherapy: a Proof-of-concept Trial
| Status: | Completed |
|---|---|
| Conditions: | Depression, Schizophrenia, Psychiatric, Bipolar Disorder |
| Therapuetic Areas: | Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/21/2016 |
| Start Date: | May 2010 |
| End Date: | April 2014 |
This study involves pilot testing of a modified version of a proven treatment for mental
illness. The treatment, electroconvulsive therapy (ECT) is used to treat more than 100,000
Americans yearly. ECT is the most effective treatment for major depression, a disorder that
affects approximately 5 to 8 percent of the adult US population yearly. It is also an
effective treatment for mania and mixed mood states associated with bipolar disorder and
schizoaffective disorder.
The aim of ECT is to induce a seizure, which is thought to be responsible for both its
therapeutic and its adverse cognitive effects. The proposed modification consists of
reducing the ECT electrical stimulus dose below the amount necessary to induce seizures so
that adverse cognitive effects, such as confusion and memory problems, are minimized.
The investigators intend to determine whether ECT-related cognitive impairment can be
reduced without diminishing the therapeutic effect of ECT. In addition to distressing
patients, ECT-related cognitive impairment has significant public health consequences. These
include increased morbidity and mortality among severely ill individuals who refuse ECT due
to concern over its adverse cognitive effects as well as increased falls among the elderly
receiving ECT. Elderly patients are far more likely to receive ECT and are also more
vulnerable to ECT-related cognitive impairment. They often require hospitalization for ECT
and a longer hospital stay with greater spacing of treatments to minimize adverse cognitive
effects.
The hypothesis driving this research is that electrical brain stimulation applied in the
same manner as standard ECT, but at a lower dose, can have therapeutic effects and fewer
adverse cognitive effects without inducing seizures. This hypothesis is based on the
following: 1) the investigators clinical experience of patients who have improved with ECT
despite having only one or no seizure, 2) animal studies showing that electrical brain
stimulation can induce antidepressant like effects in animals without inducing seizures, 3)
reports from the 1950s that "subconvulsive" and "nonconvulsive" electrotherapy was effective
for some patients, and 4) the recent approval by the US Food and Drug Administration of the
use of transcranial magnetic stimulation --a technique that uses a magnet to induce an
electrical current in the brain without inducing seizures--for treatment of medication
resistant major depression.
The primary aim of the research is to conduct a proof of concept, open trial investigating
the therapeutic efficacy and safety of nonconvulsive electrotherapy (NET). The investigators
plan to enroll 16 subjects, which is the minimum number of subjects needed to show that the
therapeutic effect of NET is better than would be expected of placebo. If the investigators
show that the therapeutic effect of NET exceeds that expected of placebo and does not induce
significant cognitive impairment, then the investigators will go on to propose a blind,
randomized, controlled clinical trial that more definitively tests the investigators'
hypothesis. The investigators would use the information gathered from the pilot trial to
estimate the number of subjects needed to definitively test the efficacy and safety of NET.
The secondary aim of the study is to find out whether NET affects blood levels of
brain-derived neurotrophic factor (BDNF). BDNF is a substance that is important to the
nervous system and may be related to how treatments like ECT or possibly NET improve
symptoms. The investigators would draw a blood sample before and after NET treatment to
assess this.
illness. The treatment, electroconvulsive therapy (ECT) is used to treat more than 100,000
Americans yearly. ECT is the most effective treatment for major depression, a disorder that
affects approximately 5 to 8 percent of the adult US population yearly. It is also an
effective treatment for mania and mixed mood states associated with bipolar disorder and
schizoaffective disorder.
The aim of ECT is to induce a seizure, which is thought to be responsible for both its
therapeutic and its adverse cognitive effects. The proposed modification consists of
reducing the ECT electrical stimulus dose below the amount necessary to induce seizures so
that adverse cognitive effects, such as confusion and memory problems, are minimized.
The investigators intend to determine whether ECT-related cognitive impairment can be
reduced without diminishing the therapeutic effect of ECT. In addition to distressing
patients, ECT-related cognitive impairment has significant public health consequences. These
include increased morbidity and mortality among severely ill individuals who refuse ECT due
to concern over its adverse cognitive effects as well as increased falls among the elderly
receiving ECT. Elderly patients are far more likely to receive ECT and are also more
vulnerable to ECT-related cognitive impairment. They often require hospitalization for ECT
and a longer hospital stay with greater spacing of treatments to minimize adverse cognitive
effects.
The hypothesis driving this research is that electrical brain stimulation applied in the
same manner as standard ECT, but at a lower dose, can have therapeutic effects and fewer
adverse cognitive effects without inducing seizures. This hypothesis is based on the
following: 1) the investigators clinical experience of patients who have improved with ECT
despite having only one or no seizure, 2) animal studies showing that electrical brain
stimulation can induce antidepressant like effects in animals without inducing seizures, 3)
reports from the 1950s that "subconvulsive" and "nonconvulsive" electrotherapy was effective
for some patients, and 4) the recent approval by the US Food and Drug Administration of the
use of transcranial magnetic stimulation --a technique that uses a magnet to induce an
electrical current in the brain without inducing seizures--for treatment of medication
resistant major depression.
The primary aim of the research is to conduct a proof of concept, open trial investigating
the therapeutic efficacy and safety of nonconvulsive electrotherapy (NET). The investigators
plan to enroll 16 subjects, which is the minimum number of subjects needed to show that the
therapeutic effect of NET is better than would be expected of placebo. If the investigators
show that the therapeutic effect of NET exceeds that expected of placebo and does not induce
significant cognitive impairment, then the investigators will go on to propose a blind,
randomized, controlled clinical trial that more definitively tests the investigators'
hypothesis. The investigators would use the information gathered from the pilot trial to
estimate the number of subjects needed to definitively test the efficacy and safety of NET.
The secondary aim of the study is to find out whether NET affects blood levels of
brain-derived neurotrophic factor (BDNF). BDNF is a substance that is important to the
nervous system and may be related to how treatments like ECT or possibly NET improve
symptoms. The investigators would draw a blood sample before and after NET treatment to
assess this.
Inclusion Criteria:
1. Men and women, aged 18 years and older meeting structured clinical interview for the
DSM IV (SCID) criteria for unipolar major depressive disorder, bipolar disorder, or
schizoaffective disorder.
2. Subjects of child-bearing potential must agree to have a pregnancy test prior to
enrollment and agree to use a reliable method of birth-control during the study.
3. Willingness and ability to provide informed consent as determined by satisfactorily
completing the study-specific Evaluation to Sign Consent Form Test.
4. Baseline score ≥ 16 on the 21-item version of the Hamilton Depression Rating Scale
(HAMD-21) for unipolar depression, the Bipolar Depression Rating Scale (BDRS) for
bipolar depression, or the Young Mania rating scale (YMRS) for mania.
5. Willingness to allow the Principal Investigator to discuss study participation with
treating psychiatrist
6. Taking the same regimen of psychiatric medications with no changes for at least one
month prior to NET treatment and willingness to not have any medication changes
during NET treatment.
7. Currently an outpatient.
8. History of or currently refusing ECT due to experience of or anticipation of adverse
effects.
Exclusion Criteria:
1. Pregnancy.
2. Use of any investigational drugs within 30 days of baseline or at any time during the
study.
3. Ongoing substance abuse or dependence.
4. Current suicidal ideas.
5. Presence of any condition that would contraindicate ECT or bifrontal electrode
placement.
6. Medical or neurologic condition etiologically related to mood disorder.
7. History of coronary artery disease or cardiac arrhythmia.
8. History of serious, potentially life-threatening reaction to anesthesia.
9. For individuals who need to have brain imaging, presence of metal in the body that
would make a head MRI unsafe.
10. For individuals who need to have brain imaging, history of claustrophobia or anxiety
associated with previous MRI.
11. Allergy or adverse reaction to methohexital or succinylcholine.
12. Epilepsy or seizure disorder.
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