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Trial record 3 of 3 for:    bipolar tms baltimore

Nonconvulsive Electrotherapy: a Proof-of-concept Trial

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ClinicalTrials.gov Identifier: NCT01065597
Recruitment Status : Completed
First Posted : February 9, 2010
Results First Posted : August 10, 2015
Last Update Posted : August 28, 2015
Sponsor:
Collaborator:
Brain & Behavior Research Foundation
Information provided by (Responsible Party):
William T Regenold, University of Maryland, College Park

Tracking Information
First Submitted Date  ICMJE February 8, 2010
First Posted Date  ICMJE February 9, 2010
Results First Submitted Date  ICMJE June 12, 2015
Results First Posted Date  ICMJE August 10, 2015
Last Update Posted Date August 28, 2015
Study Start Date  ICMJE May 2010
Actual Primary Completion Date March 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 21, 2015)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: February 8, 2010)
Change in score on the 21-item Hamilton Depression Rating Scale [ Time Frame: 2-4 weeks ]
Change History Complete list of historical versions of study NCT01065597 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 21, 2015)
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: February 8, 2010)
Change in Score on Mini-mental State Exam [ Time Frame: 2-4 weeks ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Nonconvulsive Electrotherapy: a Proof-of-concept Trial
Official Title  ICMJE Nonconvulsive Electrotherapy: a Proof-of-concept Trial
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Depressive Disorder
  • Bipolar Disorder
  • Schizoaffective Disorder
Intervention  ICMJE 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.
Study Arms  ICMJE Experimental: Nonconvulsive electrotherapy
Open label single arm study of nonconvulsive electrotherapy
Intervention: Device: Nonconvulsive electrotherapy
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 4, 2015)
13
Original Estimated Enrollment  ICMJE
 (submitted: February 8, 2010)
16
Actual Study Completion Date  ICMJE April 2014
Actual Primary Completion Date March 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01065597
Other Study ID Numbers  ICMJE HP-00040324
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party William T Regenold, University of Maryland, College Park
Study Sponsor  ICMJE University of Maryland, College Park
Collaborators  ICMJE Brain & Behavior Research Foundation
Investigators  ICMJE Not Provided
PRS Account University of Maryland, College Park
Verification Date August 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP