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Behavioural Intervention

Transcranial Magnetic Stimulation for Mental Illness (Expedition Trial)

Sunnyvale, CA

Phase 2

Recruiting

Led By Shan H Siddiqi, MD

Research Sponsored by Brigham and Women's Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age 18-65

Primary diagnosis of one of the following: major depressive disorder (MDD), obsessive-compulsive disorder (OCD), generalized anxiety disorder (GAD), or schizophrenia (determined by focal assessment using the Structured Clinical Interview for DSM-5)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion, average of 3 months

Awards & highlights

No Placebo-Only Group

Summary

This trial will involve participants receiving a non-invasive brain stimulation called Transcranial Magnetic Stimulation (TMS) at a random spot in the front part of the brain on the left side. The

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Who is the study for?

This trial is for adults aged 18-65 with certain mental illnesses like major depression, OCD, anxiety, or schizophrenia. They must score above specific thresholds on clinical scales that measure the severity of their condition and have a stable medication regimen or be medication-free for at least four weeks.Check my eligibility

What is being tested?

The study tests Transcranial Magnetic Stimulation (TMS) targeting different areas in the left prefrontal cortex to see how it affects behavior. Participants will receive TMS at random safe sites while undergoing behavioral testing to identify which brain circuits influence specific behaviors.See study design

What are the potential side effects?

TMS may cause discomfort at the stimulation site, headache, lightheadedness, or seizures in very rare cases. Some individuals might experience temporary changes in thinking or mood.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 18 and 65 years old.

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I have been diagnosed with MDD, OCD, GAD, or schizophrenia.

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Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion, average of 3 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion, average of 3 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, average of 3 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Clustering of multiple behavioral measures

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Experimental Treatment

Group I: TMS to random PFC location 2Experimental Treatment1 Intervention

After a 2-month washout following arm 1, participants will receive another two days of accelerated iTBS treatment at a different random PFC location.

Group II: TMS to random PFC location 1Experimental Treatment1 Intervention

Participants will receive 2 days of accelerated TMS (10 treatments per day) to a random location in the prefrontal cortex.

Group III: TMS to Schizophrenia locationExperimental Treatment1 Intervention

Patients with schizophrenia will be offered to participate in a third arm of the trial, during which participants will receive 2 days of accelerated iTBS to a schizophrenia-specific target.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Transcranial magnetic stimulation

2015

Completed Phase 4

~710

0 / 2Eligibility criteria met