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Nonconvulsive Electrotherapy: a Proof-of-concept Trial

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01065597
Recruitment Status : Completed
First Posted : February 9, 2010
Results First Posted : August 10, 2015
Last Update Posted : August 28, 2015
Brain & Behavior Research Foundation
Information provided by (Responsible Party):
William T Regenold, University of Maryland, College Park

Brief Summary:

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.

Condition or disease Intervention/treatment Phase
Depressive Disorder Bipolar Disorder Schizoaffective Disorder Device: Nonconvulsive electrotherapy Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 13 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Nonconvulsive Electrotherapy: a Proof-of-concept Trial
Study Start Date : May 2010
Actual Primary Completion Date : March 2014
Actual Study Completion Date : April 2014

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Nonconvulsive electrotherapy
Open label single arm study of nonconvulsive electrotherapy
Device: Nonconvulsive electrotherapy
An electrical stimulus will be given as in electroconvulsive therapy (ECT)using bifrontal electrode placement and a Thymatron System IV device; however, the device will be set at a lower energy level that is 12.5%(1/8) of the expected energy needed to induce a seizure rather than at an energy level that is at or above the seizure threshold.
Other Name: Thymatron System IV device made by Somatics, LLC.

Primary Outcome Measures :
  1. Change in Score on the 17-item Hamilton Depression Rating Scale [ Time Frame: Baseline and at the end of the NET treatment course 2-4 weeks later, depending on the number of NET treatments ]
    Score range is 0 to 54 points. The higher the score, the more depressed symptoms.

Secondary Outcome Measures :
  1. Change in Score on Mini-mental State Exam [ Time Frame: Baseline and at the end of the NET treatment course 2-4 weeks later, depending on the number of NET treatments ]
    Score range is 0 to 30 points. The higher the score, the better the cognition. So a higher score means less cognitive impairment.

  2. Change in Score on the Autobiographical Memory Inventory Short Form (AMI-S) [ Time Frame: Baseline and at the end of the NET treatment course 2-4 weeks later, depending on the number of NET treatments ]
    The Autobiographical Memory Inventory Short Form (AMI-S ) assesses effects on retrograde memory for autobiographical information including information related to a family member, recent travel, events of last New Year's eve, events of last birthday, employment information, and events of last non-psychiatric illness and its treatment. Subjects responded to specific questions regarding these topics before and after their course of NET treatment. Subjects were scored based on the percent of responses post-NET treatment that correctly matched their responses prior to NET treatment. The score range is 0 to 100%. The higher the percent, the less impaired is the autobiographical memory.

  3. Change in Brain-derived Neurotrophic Factor (BDNF) Blood Level [ Time Frame: Baseline and at the end of the NET treatment course 2-4 weeks later, depending on the number of NET treatments ]
    Change in plasma level of BDNF in pg/ml pre and post NET treatment course.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01065597

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United States, Maryland
University of Maryland Medical Center
Baltimore, Maryland, United States, 21201
Sponsors and Collaborators
University of Maryland, College Park
Brain & Behavior Research Foundation

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: William T Regenold, Associate Professor of Psychiatry, University of Maryland, College Park Identifier: NCT01065597     History of Changes
Other Study ID Numbers: HP-00040324
First Posted: February 9, 2010    Key Record Dates
Results First Posted: August 10, 2015
Last Update Posted: August 28, 2015
Last Verified: August 2015

Keywords provided by William T Regenold, University of Maryland, College Park:
electroconvulsive therapy
major depression
bipolar disorder

Additional relevant MeSH terms:
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Bipolar Disorder
Bipolar and Related Disorders
Depressive Disorder
Psychotic Disorders
Pathologic Processes
Mood Disorders
Mental Disorders
Behavioral Symptoms
Schizophrenia Spectrum and Other Psychotic Disorders