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

NARecruitingINTERVENTIONAL
Enrollment

35

Participants

Timeline

Start Date

November 8, 2022

Primary Completion Date

July 31, 2027

Study Completion Date

October 31, 2027

Conditions
Major Depressive DisorderBipolar DisorderUnipolar Major Depression
Interventions
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

Trial Locations (1)

20892

RECRUITING

National Institutes of Health Clinical Center, Bethesda

All Listed Sponsors
lead

National Institute of Mental Health (NIMH)

NIH