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NCT Number: NCT05343598

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

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.

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Key information

Conditions

Schizophrenia Mental Disorders Psychotic Disorders Schizo Affective Disorder Schizophrenia Spectrum and Other Psychotic Disorders

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

McLean Hospital

Belmont, Massachusetts, 02478, United States

Location status: Recruiting

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Repetitive transcranial magnetic stimulation (rTMS)

Device

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.

Other names: iTBS

SHAM repetitive transcranial magnetic stimulation (rTMS)

Device

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.

Other names: iTBS

Primary outcomes

  1. functional connectivity

    Time frame: baseline, 1 week after TMS

    change in functional connectivity of a putative cerebellar-thalamic-cortical hallucination circuit (cerebellum to thalamus) will be assessed before and after (1 week followup) TMS stimulation.

  2. Positive and Negative Syndrome Scale (PANSS)

    Time frame: baseline

    The PANSS is clinical rating scale of symptom severity . Each descriptor is rated on a 7 point scale from 1=(absence of any symptom) to 7=(extremely severe symptoms).

  3. Scale for the Assessment of Positive Symptoms (SAPS)

    Time frame: baseline

    The SAPS is clinical rating scale of symptom severity . Each descriptor is rated on a 5 point scale from 1=(absence of any symptom) to 5=(extremely severe symptoms).

  4. Auditory Hallucination Rating Scale (AHRS) Scale (AHRS)

    Time frame: baseline

    The AHRS is a 7-item clinical rating scale used to assess auditory hallucinations.

Study contacts

Contact information is provided by the study sponsor or research team.

Mark Halko, PhD

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Mclean Hospital

Other

Collaborators

  • Beth Israel Deaconess Medical Center
  • National Institute of Mental Health (NIMH)

Registry information

Official study title

Empirical Validation of a Cerebellar-cortical Hallucination Circuit

Important dates

Study start
2021
Primary completion
2026
Study completion
2026
First posted
Apr 25, 2022
Registry last updated
Jan 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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