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ACTIVE NOT RECRUITING
NCT07868627
PHASE2

Novel and Conventional Interventions for Cognitive and Emotional Flexibility in Patient Trauma

Sponsor: Mclean Hospital

View on ClinicalTrials.gov

Summary

This study is testing whether combining a rapid form of transcranial magnetic stimulation (TMS), an oral medication called d-cycloserine (DCS), and therapy can improve brain flexibility and emotional control in adults experiencing moderate-to-severe depression, anxiety, or trauma symptoms. TMS is a non-invasive treatment that uses gentle magnetic pulses to stimulate specific areas of the brain. In this phase of the study, all participants receive active accelerated TMS (delivering multiple brief sessions in a single day) along with DCS, a medication that helps enhance brain learning and plasticity. Participants will be randomly assigned to have TMS directed at one of two brain targets: a region called the precuneus (identified using personalized brain scans) or the dorsolateral prefrontal cortex (a standard area for mood treatment). Afterward, participants are randomly assigned to complete three weeks of either therapist-led talk therapy (a modified Unified Protocol) or self-guided educational videos and readings. The main goals are to determine which brain stimulation target works best and to see whether therapist-led therapy leads to more lasting symptom relief and brain changes compared to self-guided education.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

75

Start Date

2025-06-01

Completion Date

2027-03-01

Last Updated

2026-10-09

Healthy Volunteers

No

Interventions

DRUG

D-Cycloserine (DCS)

Single dose of 125 mg of D-cycloserine

DEVICE

Transcranial Magnetic Stimulation

TMS delivered to either the DLPFC or the precuneus

BEHAVIORAL

Unified Protocol

Cognitive Behavioral Therapy delivered in an abbreviated schedule by a licensed therapist

BEHAVIORAL

Psychoeducation

Self-lead psychoeducation

Locations (1)

McLean Hospital

Belmont, Massachusetts, United States