Psychosis TMS Study

Mass General Brigham

Status: Active, not recruiting

Conditions: Psychosis

Treatments: Device: Placebo TMS; Device: Active TMS

Study type: Interventional

Funder types: Other

Identifiers

NCT05857137

2018P000014

Details and patient eligibility

About

The main goal of this study is to investigate the neural mechanisms of working memory function in patients with early psychosis using Transcranial Magnetic Stimulation (TMS) in conjunction with functional MRI. TMS is a noninvasive method used to modulate brain activity via changing magnetic fields applied over the surface of the scalp.

Enrollment: 20 estimated patients

Sex: All

Ages: 18 to 35 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosis of psychosis, psychosis not otherwise specified, schizophrenia, schizoaffective disorder, delusional disorder, bipolar disorder with psychosis, and schizophreniform disorder within first ten years of onset of psychotic symptoms.
• Ability to provide informed consent

Exclusion criteria

• TMS incompatibility including metallic implants in head and neck, cardiac pacemakers, history of seizures, pregnancy.
• MRI-incompatibility including implanted aneurism clips, cardiac pacemakers, metal implants, intrauterine devices, tattoos containing metal ink, pregnancy, and claustrophobia
• Severe substance abuse within 3 months (nicotine allowed)
• Unstable medical or neurologic illness that would preclude participation in study procedures

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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20 participants in 2 patient groups, including a placebo group

Active TMS

Experimental group

Description:

Participants will receive single-session administration of TMS. Functional MRI will be acquired before and immediately after the intervention.

Treatment:

Device: Active TMS

Placebo TMS

Placebo Comparator group

Description:

Participants will also receive single session administration of placebo TMS (at least two days apart from the day of the active TMS). Functional MRI will be acquired before and immediately after the intervention.

Treatment:

Device: Placebo TMS