NCT05172271

Transcranial Electric Stimulation Therapy (TEST) for Treatment Resistant Depression (TRD)

A Feasibility Study of Transcranial Electric Stimulation Therapy (TEST) for Treatment Resistant Depression (TRD)

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: National Institute of Mental Health (NIMH) · NIH
• Sex: All
• Age: 25 Years – 64 Years
• Healthy volunteers: Not accepted

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

Conditions

• Major Depressive Disorder
• Bipolar Disorder
• Unipolar Major Depression

Interventions

Type	Name	Description
DEVICE	MagPro TMS Stimulator and coil	TMS measurements of cortical excitability pre and post study intervention
DEVICE	Thymatron(R) System IV	The Thymatron(R) System IV (Somatics LLC, Venice, FL, USA) is an FDA 510(k)-cleared ECT device. For TESt, we will be using it in a non FDA-approved manner--stimulating without intending to induce seizures.
DEVICE	Magnetic Resonance Imaging Scanner	Conventional MRI studies in this protocol are considered non-significant risk (NSR) devices. While operated in research mode, the MRI will be under the International Electrotechnical Commission (IEC) 60601-2-33 First Level Controlled Operating Mode, which allows for research pulse sequences to be used within the FDA/IEC safety limits for MRI devices.
OTHER	ECT device without stimulation	Anesthesia alone

Timeline

• Start date: 2022-11-08
• Primary completion: 2027-07-31
• Completion: 2027-10-31
• First posted: 2021-12-29
• Last updated: 2026-03-17

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study