Empirical Validation of a Cerebellar-cortical Hallucination Circuit
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Mclean Hospital
- Enrollment
- 68
- Locations
- 1
- Primary Endpoint
- functional connectivity
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Basic Science
- 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.
Eligibility Criteria
- Ages
- 18 Years to 55 Years (Adult)
- Sex
- 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
Arms & Interventions
Active cerebellum rTMS
Cerebellar targeted iTBS, twice daily, one week.
Intervention: Repetitive Transcranial Magnetic Stimulation (rTMS) (Device)
Sham cerebellum rTMS
Cerebellar targeted sham iTBS, twice daily, one week.
Intervention: Sham Repetitive Transcranial Magnetic Stimulation (rTMS) (Device)
Outcomes
Primary Outcomes
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.
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).
Auditory Hallucination Rating Scale (AHRS) Scale (AHRS)
Time Frame: baseline
The AHRS is a 7-item clinical rating scale used to assess auditory hallucinations.
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).
Secondary Outcomes
No secondary outcomes reported
Investigators
Mark A. Halko, PhD
Assistant Professor of Psychiatry
Mclean Hospital