Using Transcranial Magnetic Stimulation (TMS) to Understand Hallucinations in Schizophrenia
- Conditions
- Schizo Affective DisorderSchizophrenia
- Interventions
- Device: Repetitive Transcranial Magnetic Stimulation (rTMS)Device: Sham Repetitive Transcranial Magnetic Stimulation (rTMS)
- Registration Number
- NCT05343598
- Lead Sponsor
- Mclean Hospital
- 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.
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 68
- Diagnosis of schizophrenia or schizoaffective disorder
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Active cerebellum rTMS Repetitive Transcranial Magnetic Stimulation (rTMS) Cerebellar targeted iTBS, twice daily, one week. Sham cerebellum rTMS Sham Repetitive Transcranial Magnetic Stimulation (rTMS) Cerebellar targeted sham iTBS, twice daily, one week.
- Primary Outcome Measures
Name Time Method 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.
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).
Auditory Hallucination Rating Scale (AHRS) Scale (AHRS) baseline The AHRS is a 7-item clinical rating scale used to assess auditory hallucinations.
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).
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
McLean Hospital
🇺🇸Belmont, Massachusetts, United States