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NOT YET RECRUITING
NCT07785102
EARLY_PHASE1

Single Day of Ultra-accelerated TMS With a Single Dose of NRX-101

Sponsor: Mclean Hospital

View on ClinicalTrials.gov

Summary

In this pilot study, investigators aim to combine D-cycloserine, lurasidone, and single-day repeated intermittent Theta Burst Stimulation (iTBS) to preliminarily assess clinical improvement in an open-label cohort and monitor for adverse events over a 6-week follow-up period.

Official title: SPARC-LI: Synaptic Plasticity Augmented Rapid Circuit Stimulation

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

30

Start Date

2026-09-01

Completion Date

2027-03-31

Last Updated

2026-08-25

Healthy Volunteers

No

Interventions

DEVICE

TMS

Transcranial Magnetic Stimulation (TMS): TMS involves a procedure where a coil is placed on the scalp and magnetic energy enters the participant's brain in pulses. TMS does not alter consciousness or impose restrictions of any kind on a participant after a session. Single pulses of TMS are delivered to probe cortical excitability, as a surrogate of plasticity, before and after each treatment session. Excitability is measured with neurophysiology including electromyography (EMG). Repetitive TMS (rTMS) administered in the study is delivered in a pattern protocol called intermittent-theta burst stimulation (iTBS) which has been FDA-cleared for-and shown to be effective in-the treatment of depression. We aim to deliver up to 20 sessions per day but can adapt for patient or staff related scheduling challenges or tolerability

DRUG

NRX-101

NRX-101 is a combination capsule of fixed dose d-cycloserine (175 mg) and lurasidone (8.25 mg)

Locations (1)

McLean Hospital

Belmont, Massachusetts, United States