Cerebellar TMS and Satiety in Prader-Willi Syndrome
Primary Purpose
Prader-Willi Syndrome
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Repetitive Transcranial Magnetic Stimulation (rTMS)
Sponsored by
About this trial
This is an interventional basic science trial for Prader-Willi Syndrome
Eligibility Criteria
Inclusion Criteria: Diagnosis of Prader-Willi syndrome Exclusion Criteria: 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
Sites / Locations
- McLean HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Active cerebellum rTMS
Arm Description
Cerebellar targeted iTBS, once daily, one week
Outcomes
Primary Outcome Measures
Retention of subjects in study assessments
Retention of subjects for assessments at baseline and 1-week post-TMS follow-up visit, as measured by the percentage (%) of enrolled subjects who complete baseline assessments and then go on to complete the 1-week post-TMS follow-up visit.
Time required to enroll subjects into study
Time required to enroll the target sample size (n=12) into the study
Change in BOLD response
Change in functional activation of the cerebellum and ventral striatum will be assessed before (baseline) and after TMS stimulation (1-week post-TMS follow-up visit)
Secondary Outcome Measures
Full Information
NCT ID
NCT05938543
First Posted
June 13, 2023
Last Updated
October 11, 2023
Sponsor
Brigham and Women's Hospital
Collaborators
Foundation for Prader-Willi Research
1. Study Identification
Unique Protocol Identification Number
NCT05938543
Brief Title
Cerebellar TMS and Satiety in Prader-Willi Syndrome
Official Title
Noninvasive Neuromodulation of a Novel Cerebellar Satiety Circuit in Prader-Willi Syndrome
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 1, 2023 (Actual)
Primary Completion Date
October 2024 (Anticipated)
Study Completion Date
August 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Brigham and Women's Hospital
Collaborators
Foundation for Prader-Willi Research
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.
No
5. Study Description
Brief Summary
This study uses a noninvasive technique called transcranial magnetic stimulation (TMS) to study hyperphagia and satiety in Prader-Willi syndrome.
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 hyperphagia in Prader-Willi syndrome.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prader-Willi Syndrome
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Active cerebellum rTMS
Arm Type
Experimental
Arm Description
Cerebellar targeted iTBS, once daily, one week
Intervention Type
Device
Intervention Name(s)
Repetitive Transcranial Magnetic Stimulation (rTMS)
Intervention Description
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 an electrical current in neurons and allows for modulation of neural circuitry.
Other Name: iTBS
Primary Outcome Measure Information:
Title
Retention of subjects in study assessments
Description
Retention of subjects for assessments at baseline and 1-week post-TMS follow-up visit, as measured by the percentage (%) of enrolled subjects who complete baseline assessments and then go on to complete the 1-week post-TMS follow-up visit.
Time Frame
1-week post-TMS follow-up visit
Title
Time required to enroll subjects into study
Description
Time required to enroll the target sample size (n=12) into the study
Time Frame
At study completion, up to 18 months
Title
Change in BOLD response
Description
Change in functional activation of the cerebellum and ventral striatum will be assessed before (baseline) and after TMS stimulation (1-week post-TMS follow-up visit)
Time Frame
baseline, 1-week post-TMS follow-up visit
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diagnosis of Prader-Willi syndrome
Exclusion Criteria:
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Laura Holsen, PhD
Phone
617-525-8772
Email
lholsen@bwh.harvard.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Laura Holsen, PhD
Organizational Affiliation
Brigham and Women's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
McLean Hospital
City
Belmont
State/Province
Massachusetts
ZIP/Postal Code
02478
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mark Halko, PhD
Email
mhalko@mclean.harvard.edu
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Cerebellar TMS and Satiety in Prader-Willi Syndrome
We'll reach out to this number within 24 hrs