Recruiting

TMS

Sponsor:

Mclean Hospital

Code:

NCT05343598

Conditions

Schizophrenia

Schizo Affective Disorder

Eligibility Criteria

Sex: All

Age: 18 - 55

Healthy Volunteers: Not accepted

Interventions

Repetitive Transcranial Magnetic Stimulation (rTMS)

Sham Repetitive Transcranial Magnetic Stimulation (rTMS)

Study Details

Brief summary:

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.

Conditions

Schizophrenia

Schizo Affective Disorder

Study ID

NCT05343598

Start date

Oct 13, 2021

Status verified date

Jan, 2026

Completion date

Oct 31, 2026

Anticipated

Primary completion date

Oct 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 55

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

68 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

active comparator: Active cerebellum rTMS

Cerebellar targeted iTBS, twice daily, one week.

sham comparator: Sham cerebellum rTMS

Cerebellar targeted sham iTBS, twice daily, one week.

Interventions

Repetitive Transcranial Magnetic Stimulation (rTMS)

rTMS is a technique of TMS that allows for selective external manipulation of neural activity in a non-invasive manner. During rTMS a rapidly changing current is passed through an insulated coil placed against the scalp. This generates a temporary magnetic field, which in turn induces electrical current in neurons and allows for modulation of neural circuitry.

The rTMS pulses will be delivered in a pattern consisting of 2 s trains of 3 pulses at 50 Hz, repeated at 5 Hz every 10s for 600 total pulses.

Sham Repetitive Transcranial Magnetic Stimulation (rTMS)

rTMS is a technique of TMS that allows for selective external manipulation of neural activity in a non-invasive manner. During rTMS a rapidly changing current is passed through an insulated coil placed against the scalp. This generates a temporary magnetic field, which in turn induces electrical current in neurons and allows for modulation of neural circuitry.

The rTMS pulses will be delivered in a pattern consisting of 2 s trains of 3 pulses at 50 Hz, repeated at 5 Hz every 10s for 600 total pulses.

Sham is achieved by using a coil with a magnetic shield preventing magnetic field from reaching the head.

Primary outcome measure

  • functional connectivity [ Time Frame: baseline, 1 week after TMS ]
  • Positive and Negative Syndrome Scale (PANSS) [ Time Frame: baseline ]
  • Scale for the Assessment of Positive Symptoms (SAPS) [ Time Frame: baseline ]
  • Auditory Hallucination Rating Scale (AHRS) Scale (AHRS) [ Time Frame: baseline ]

Central Contacts and Locations

Central contacts

Mark Halko, PhD

mhalko@mclean.harvard.edu

Locations

McLean Hospital

Recruiting

Belmont, Massachusetts, United States, 02478

More Information

Sponsor

Mclean Hospital

Last update posted

Jan 22, 2026

Last verified

Jan, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Mclean Hospital on 2026-01-22.