Ignite Creation Date:
2024-05-05 @ 10:14 PM
Last Modification Date:
2024-10-26 @ 10:16 AM
Study NCT ID:
NCT01065597
Status:
COMPLETED
Last Update Posted:
2023-06-23
First Post:
2010-02-08
Brief Title:
Nonconvulsive Electrotherapy a Proof-of-concept Trial
Sponsor:
University of Maryland College Park
Organization:
University of Maryland College Park
Study Overview
Official Title:
Nonconvulsive Electrotherapy a Proof-of-concept Trial
Status:
COMPLETED
Status Verified Date:
2023-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 100000 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
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:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None