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Impact of Cerebellar TMS on Brain and Cognitive Functions in Schizophrenia: a Pilot Study

Primary Purpose

Schizophrenia, Cerebellar Function, Condition

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Transcranial Magnetic Stimulation
Sponsored by
Northwell Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Male or female subjects 18 to 40 years of age
  2. DSM-V diagnosis of schizophrenia spectrum disorders
  3. Competent to provide informed consent

Exclusion Criteria:

  1. Lifetime DSM-V diagnosis of an Axis-I disorder other than schizophrenia spectrum disorders
  2. Lifetime diagnosis of ataxia or other cerebellar disorders
  3. Lifetime diagnosis of mental retardation, dementia, Alzheimer's disease, Parkinson's disease, Huntington's disease, or other neurodegenerative disorders
  4. Any active general medical condition or CNS disease which can affect cognition or response to treatment
  5. Substance dependence or abuse in the past six months
  6. Seizure history
  7. TMS within three months or ECT within six months
  8. Pregnancy as indicated by self-report
  9. MRI contraindications

Sites / Locations

  • Zucker Hillside HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

TMS

Sham

Arm Description

Outcomes

Primary Outcome Measures

Cerebellar function
Changes of cerebellar connectivity after TMS treatment compared with baseline, as measured by functional magnetic resonance imaging (fMRI)

Secondary Outcome Measures

Cognitive function
Changes of scores for the Brief Assessment of Cognition in Schizophrenia (BACS) battery after TMS treatment compared with baseline

Full Information

First Posted
May 12, 2022
Last Updated
September 12, 2023
Sponsor
Northwell Health
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1. Study Identification

Unique Protocol Identification Number
NCT05389787
Brief Title
Impact of Cerebellar TMS on Brain and Cognitive Functions in Schizophrenia: a Pilot Study
Official Title
Impact of Cerebellar TMS on Brain and Cognitive Functions in Schizophrenia: a Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 18, 2022 (Actual)
Primary Completion Date
August 31, 2025 (Anticipated)
Study Completion Date
August 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Northwell Health

4. Oversight

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.
Yes
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This is a single-site, sham-controlled, randomized trial in a total of 60 subjects between ages 18 and 40 years with schizophrenia. This study will investigate the effects of 4-week rTMS treatment on brain and cognitive functions in patients. Subjects will be randomized to one of the following arms: Arm 1: Standard of Care (SOC) and active rTMS Arm 2: Standard of Care (SOC) and sham rTMS Each participant will receive rTMS five days per week, for four consecutive weeks. Functional magnetic resonance imaging (fMRI) scans, clinical assessments, and cognitive tests will be performed at baseline, end of the 2nd week, and end of the 4th week.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia, Cerebellar Function, Condition

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
TMS
Arm Type
Experimental
Arm Title
Sham
Arm Type
Sham Comparator
Intervention Type
Device
Intervention Name(s)
Transcranial Magnetic Stimulation
Intervention Description
The TMS will be administrated using the MagVenture Mag Pro R30 device equipped with a B-70 coil. The FDA-approved iTBS sequence will be applied: 10 bursts of three biphasic pulses at 50 Hz, repeated at 5 Hz, for 10 seconds for a total of 600 pulses, and will be repeated for three times. The total stimulation time is ~10 min per session (day). Patients will receive five sessions (days) of rTMS each week, and the total treatment will last for four weeks.
Primary Outcome Measure Information:
Title
Cerebellar function
Description
Changes of cerebellar connectivity after TMS treatment compared with baseline, as measured by functional magnetic resonance imaging (fMRI)
Time Frame
end of 2nd week and 4th week
Secondary Outcome Measure Information:
Title
Cognitive function
Description
Changes of scores for the Brief Assessment of Cognition in Schizophrenia (BACS) battery after TMS treatment compared with baseline
Time Frame
end of 2nd week and 4th week
Other Pre-specified Outcome Measures:
Title
Cerebellum-cognition associations
Description
Pearson Correlations between changes of cerebellar connectivity (as measured by fMRI) and changes of cognitive scores (as measured by BACS)
Time Frame
end of 2nd week and 4th week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male or female subjects 18 to 40 years of age DSM-V diagnosis of schizophrenia spectrum disorders Competent to provide informed consent Exclusion Criteria: Lifetime DSM-V diagnosis of an Axis-I disorder other than schizophrenia spectrum disorders Lifetime diagnosis of ataxia or other cerebellar disorders Lifetime diagnosis of mental retardation, dementia, Alzheimer's disease, Parkinson's disease, Huntington's disease, or other neurodegenerative disorders Any active general medical condition or CNS disease which can affect cognition or response to treatment Substance dependence or abuse in the past six months Seizure history TMS within three months or ECT within six months Pregnancy as indicated by self-report MRI contraindications
Facility Information:
Facility Name
Zucker Hillside Hospital
City
New York
State/Province
New York
ZIP/Postal Code
11004
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hengyi Cao, PhD
Phone
718-470-5913
Email
hcao2@northwell.edu

12. IPD Sharing Statement

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Impact of Cerebellar TMS on Brain and Cognitive Functions in Schizophrenia: a Pilot Study

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