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

Sponsor
Mclean Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT05343598
Collaborator
Beth Israel Deaconess Medical Center (Other), National Institute of Mental Health (NIMH) (NIH)
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Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Repetitive Transcranial Magnetic Stimulation (rTMS)
  • Device: Sham Repetitive Transcranial Magnetic Stimulation (rTMS)
N/A

Detailed 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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
68 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:
The subjects, care providers, investigators and outcome assessors will all be blinded as to the randomization sequence, and thus will be blinded as to sham vs active TMS status. Blinding codes are used to determine which side of an active/passive Magpro coil (cool B65 A/P, Magventure A/S, Denmark) is used for stimulation.
Primary Purpose:
Basic Science
Official Title:
Empirical Validation of a Cerebellar-cortical Hallucination Circuit
Actual Study Start Date :
Oct 13, 2021
Anticipated Primary Completion Date :
Oct 31, 2026
Anticipated Study Completion Date :
Oct 31, 2026

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Active cerebellum rTMS

Cerebellar targeted iTBS, twice daily, one week.

Device: 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.
Other Names:
  • iTBS
  • Sham Comparator: Sham cerebellum rTMS

    Cerebellar targeted sham iTBS, twice daily, one week.

    Device: 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.
    Other Names:
  • iTBS
  • Outcome Measures

    Primary Outcome Measures

    1. functional connectivity [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) [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) [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) [baseline]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 55 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 McLean Hospital Belmont Massachusetts United States 02478

    Sponsors and Collaborators

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

    Investigators

    • Principal Investigator: Mark Halko, PhD, Mclean Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Mark A. Halko, PhD, Assistant Professor of Psychiatry, Mclean Hospital
    ClinicalTrials.gov Identifier:
    NCT05343598
    Other Study ID Numbers:
    • 2021P002459
    • R01MH126000
    First Posted:
    Apr 25, 2022
    Last Update Posted:
    Aug 11, 2022
    Last Verified:
    Aug 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    Yes
    Product Manufactured in and Exported from the U.S.:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Aug 11, 2022