Using Transcranial Magnetic Stimulation (TMS) to Understand Hallucinations in Schizophrenia

Mass General Brigham

Status: Enrolling

Conditions: Schizophrenia; Schizo Affective Disorder

Treatments: Device: Repetitive Transcranial Magnetic Stimulation (rTMS); Device: Sham Repetitive Transcranial Magnetic Stimulation (rTMS)

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05343598

2021P002459

R01MH126000 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

This study uses a noninvasive technique called transcranial magnetic stimulation (TMS) to study how hallucinations work in schizophrenia.

TMS is a noninvasive way of stimulating the brain, using a magnetic field to change activity in the brain. The magnetic field is produced by a coil that is held next to the scalp. In this study the investigators will be stimulating the brain to learn more about how TMS might improve these symptoms of schizophrenia.

Full description

This study tests the hypothesis that hallucinations in schizophrenia are mediated by network pathophysiology, and that network pathophysiology can be quantified by the functional connectivity of a cerebellar-thalamo-cortical circuit. To accomplish this, participants will be recruited who are diagnosed with schizophrenia or schizoaffective disorder who experience auditory hallucinations.

Participants will undergo an initial screening session to complete informed consent and undergo baseline assessments of schizophrenia symptom severity. These assessments include reporter-based measures such as the Positive and Negative Syndrome Scale (PANSS).

Participants will then undergo an MRI scan that includes structural and resting-state functional magnetic resonance imaging (rsfMRI). These rsfMRI imagines will be used to isolate individual resting state networks for targeting of rTMS modulation.

Participants will then undergo five days of twice daily rTMS sessions.

One week after the last rTMS session, participants will undergo follow-up MRI imaging and the same study assessments.

Enrollment: 68 estimated patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosis of schizophrenia or schizoaffective disorder

Exclusion criteria

• substance use disorder in past 3 months
• ambidexterity
• contraindications for TMS or MRI including :
• history of neurological disorder
• history of head trauma resulting in loss of consciousness
• history of seizures or diagnosis of epilepsy or first degree relative family history of epilepsy
• metal in brain or skull
• implanted devices such as a pacemaker, medication pump, nerve stimulator or ventriculoperitoneal shunt
• claustrophobic in MRI

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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68 participants in 2 patient groups

Active cerebellum rTMS

Active Comparator group

Description:

Cerebellar targeted iTBS, twice daily, one week.

Treatment:

Device: Repetitive Transcranial Magnetic Stimulation (rTMS)

Sham cerebellum rTMS

Sham Comparator group

Description:

Cerebellar targeted sham iTBS, twice daily, one week.

Treatment:

Device: Sham Repetitive Transcranial Magnetic Stimulation (rTMS)