Transcranial Electric Stimulation Therapy (TEST) for Treatment Resistant Depression (TRD)
- Conditions
- Bipolar DisorderUnipolar Major DepressionMajor Depressive Disorder
- Interventions
- Device: MagPro TMS Stimulator and coilOther: ECT device without stimulationDevice: Thymatron System IVDevice: Magnetic Resonance Imaging Scanner
- Registration Number
- NCT05172271
- Lead Sponsor
- National Institute of Mental Health (NIMH)
- 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 and/or 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: 1.Treatment adverse effects with an emphasis on adverse cognitive effects, primarily memory impairment. 2.Presence 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
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 35
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Transcranial Electric Stimulation Therapy (TEST) MagPro TMS Stimulator and coil 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 (modified or unmodified) that can deliver a range of doses below seizure threshold. Transcranial Electric Stimulation Therapy (TEST) Magnetic Resonance Imaging Scanner 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 (modified or unmodified) that can deliver a range of doses below seizure threshold. Sham TEST ECT device without stimulation Anesthesia alone Transcranial Electric Stimulation Therapy (TEST) Thymatron System IV 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 (modified or unmodified) that can deliver a range of doses below seizure threshold.
- Primary Outcome Measures
Name Time Method Hopkins Verbal Learning Test-Revised (HVLT-R) Baseline, End of Phase II (approximately 2 weeks) and end of Phase III (4-13 weeks) and at 2 and 4 weeks post treatment course The HVLT-R is a brief (\<10 min) well-validated version of the word list delayed recall task that assesses anterograde memory.
change in EEG waveforms from pretreatment session baseline to end of treatment session every treatment throughout course (approximately 3x weekly) This measure will determine the presence or absence of a seizure in participants receiving TEST. It will inform the feasibility of consistently not inducing seizures with TEST.
- Secondary Outcome Measures
Name Time Method Montgomery-Asberg Depression Rating Scale (MADRS), Baseline, after every treatment (approximately 3x weekly) end of Phase II (approximately 2 weeks), end of Phase III (approximately 4-13 weeks), and during outpatient follow up every two weeks for the first month, then monthly for 5 months a 10-item, well validated, scale measuring depressive symptoms often used in ECT clinical trials.
Symptoms of Major Depressive Disorder Scale (SMDDS). Baseline, after every treatment (approximately 3x weekly), end of Phase II (approximately 2 weeks), end of Phase III (approximately 4-13 weeks), and during outpatient follow up every two weeks for the first month, then monthly for 5 months The SMDDS is a 16-item, well validated, participant-administered scale that was developed to meet the recommendations promulgated by the FDA to guide industry in the conduct of depression clinical trials
Trial Locations
- Locations (1)
National Institutes of Health Clinical Center
🇺🇸Bethesda, Maryland, United States