Ignite Creation Date:
2024-05-06 @ 5:02 PM
Last Modification Date:
2024-10-26 @ 2:21 PM
Study NCT ID:
NCT05172271
Status:
RECRUITING
Last Update Posted:
2024-06-04
First Post:
2021-12-28
Brief Title:
Transcranial Electric Stimulation Therapy TEST for Treatment Resistant Depression TRD
Sponsor:
National Institute of Mental Health NIMH
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
A Feasibility Study of Transcranial Electric Stimulation Therapy TEST for Treatment Resistant Depression TRD
Status:
RECRUITING
Status Verified Date:
2024-08-26
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:
Background
People with TRD are often helped by electroconvulsive therapy ECT But ECT can affect memory and thinking Researchers want to study a treatment called TEST that uses less electricity
Objective
To study the safety and feasibility of TEST and assess its antidepressant effects
Eligibility
Adults aged 25-64 with major depression that has not been relieved by current treatments
Design
Participants will be admitted to the NIH Clinical Center for 5 18 weeks over 2 3 treatment phases Their medications may be adjusted
Participants will be interviewed about their depression side effects and other treatments they are receiving They will complete questionnaires They will give blood and urine samples Their brain waves and heart rhythm will be recorded They will take tests of memory attention mental functioning and thinking
Participants will have magnetic resonance imaging MRI scans of the head and brain They will lie on a table that slides in and out of the scanner Pictures of brain chemicals will also be taken They may complete tasks during the MRI
Participants will receive TEST andor sham treatments They may receive optional ECT An intravenous catheter will be placed in an arm vein to receive general anesthesia Two electrodes will be placed on the front of their head An electric current will be passed from the ECT machine through the electrodes For sham treatments they will not receive the electric current Their breathing heart rate brain function blood pressure and body movements will be measured
Participants will have 7 follow-up visits over 6 months Visits can be done via telehealth
Participation will last for up to 42 weeks
People with TRD are often helped by electroconvulsive therapy ECT But ECT can affect memory and thinking Researchers want to study a treatment called TEST that uses less electricity
Objective
To study the safety and feasibility of TEST and assess its antidepressant effects
Eligibility
Adults aged 25-64 with major depression that has not been relieved by current treatments
Design
Participants will be admitted to the NIH Clinical Center for 5 18 weeks over 2 3 treatment phases Their medications may be adjusted
Participants will be interviewed about their depression side effects and other treatments they are receiving They will complete questionnaires They will give blood and urine samples Their brain waves and heart rhythm will be recorded They will take tests of memory attention mental functioning and thinking
Participants will have magnetic resonance imaging MRI scans of the head and brain They will lie on a table that slides in and out of the scanner Pictures of brain chemicals will also be taken They may complete tasks during the MRI
Participants will receive TEST andor sham treatments They may receive optional ECT An intravenous catheter will be placed in an arm vein to receive general anesthesia Two electrodes will be placed on the front of their head An electric current will be passed from the ECT machine through the electrodes For sham treatments they will not receive the electric current Their breathing heart rate brain function blood pressure and body movements will be measured
Participants will have 7 follow-up visits over 6 months Visits can be done via telehealth
Participation will last for up to 42 weeks
Detailed Description:
Study Description
This is a medical device feasibility study which per FDA definition is a study focusing primarily on continuing safety data collection that aims to capture preliminary safety and effectiveness data on a near-final or final device design to adequately plan an appropriate pivotal study It tests the hypothesis that Transcranial Electric Stimulation Therapy TEST an experimental brain stimulation therapy can have an antidepressant effect in individuals with treatment resistant depression TRD safely and without significant adverse cognitive effects TEST involves bifrontal electrical brain stimulation at a dose below the seizure threshold applied in the same manner as standard electroconvulsive therapy ECT with scalp electrodes under anesthesia using a standard ECT device The effects of TEST will be compared to those of sham TEST anesthesia alone in 30 patients with TRD in a randomized double-blind parallel trial followed by a nonrandomized extension during which all participants are eligible for active treatment
Objectives
Primary Objective To evaluate the safety and feasibility of TEST in 30 adults with treatment resistant major depression TRD
Secondary Objectives To assess the antidepressant effect of TEST
Endpoints Primary Endpoints 1Treatment adverse effects with an emphasis on adverse cognitive effects primarily memory impairment 2Presence or absence of a seizure in participants receiving TEST feasibility of consistently not inducing seizures with TEST
Secondary Endpoint Treatment-related changes in depressive symptom scale score
This is a medical device feasibility study which per FDA definition is a study focusing primarily on continuing safety data collection that aims to capture preliminary safety and effectiveness data on a near-final or final device design to adequately plan an appropriate pivotal study It tests the hypothesis that Transcranial Electric Stimulation Therapy TEST an experimental brain stimulation therapy can have an antidepressant effect in individuals with treatment resistant depression TRD safely and without significant adverse cognitive effects TEST involves bifrontal electrical brain stimulation at a dose below the seizure threshold applied in the same manner as standard electroconvulsive therapy ECT with scalp electrodes under anesthesia using a standard ECT device The effects of TEST will be compared to those of sham TEST anesthesia alone in 30 patients with TRD in a randomized double-blind parallel trial followed by a nonrandomized extension during which all participants are eligible for active treatment
Objectives
Primary Objective To evaluate the safety and feasibility of TEST in 30 adults with treatment resistant major depression TRD
Secondary Objectives To assess the antidepressant effect of TEST
Endpoints Primary Endpoints 1Treatment adverse effects with an emphasis on adverse cognitive effects primarily memory impairment 2Presence or absence of a seizure in participants receiving TEST feasibility of consistently not inducing seizures with TEST
Secondary Endpoint Treatment-related changes in depressive symptom scale score
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 21-M-0031 | None | None | None |