Back to resultsPrecision-targeted Transcranial Magnetic Stimulation in the Treatment of Primary Dystonia
Primary Purpose
Primary Dystonia, Transcranial Magnetic Stimulation
Status
Unknown status
Phase
Early Phase 1
Locations
China
Study Type
Interventional
Intervention
Transcranial magnetic stimulation
Sponsored by
About this trial
This is an interventional treatment trial for Primary Dystonia
Eligibility Criteria
Inclusion Criteria:
- Primary dystonia
Exclusion Criteria:
- None
Sites / Locations
- Zhejiang UniversityRecruiting
Outcomes
Primary Outcome Measures
Burke-Fahn-Marsden dystonia rating scale
The BFMMS measures dystonia in nine body regions (including the eyes, mouth, speech and swallowing, neck, trunk, arms, and legs) with scores ranging from 0 (minimum) to 120 (maximum).The higher scores mean a worse outcome.
The BFMDS is a functional marker consisting of parental- or self-reported daily activities (involving speech, handwriting,feeding, eating, swallowing, hygiene, dressing, and walking),with scores ranging from 0 (completely independent) to 30 (completely dependent).
Secondary Outcome Measures
Full Information
NCT ID
NCT04727177
First Posted
January 24, 2021
Last Updated
March 16, 2021
Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
Collaborators
Hangzhou Normal University
1. Study Identification
Unique Protocol Identification Number
NCT04727177
Brief Title
Precision-targeted Transcranial Magnetic Stimulation in the Treatment of Primary Dystonia
Official Title
Precision-targeted Transcranial Magnetic Stimulation in the Treatment of Primary Dystonia
Study Type
Interventional
2. Study Status
Record Verification Date
January 2021
Overall Recruitment Status
Unknown status
Study Start Date
November 1, 2020 (Actual)
Primary Completion Date
April 1, 2021 (Anticipated)
Study Completion Date
May 1, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
Collaborators
Hangzhou Normal University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
In this scheme, TMS treatment of Primary dystonia is planned by precise magnetic resonance positioning.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Dystonia, Transcranial Magnetic Stimulation
7. Study Design
Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
Outcomes Assessor
Allocation
N/A
Enrollment
1 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Device
Intervention Name(s)
Transcranial magnetic stimulation
Intervention Description
Transcranial magnetic stimulation (TMS) is a noninvasive biological stimulation technique born in the middle of 1980's.
Primary Outcome Measure Information:
Title
Burke-Fahn-Marsden dystonia rating scale
Description
The BFMMS measures dystonia in nine body regions (including the eyes, mouth, speech and swallowing, neck, trunk, arms, and legs) with scores ranging from 0 (minimum) to 120 (maximum).The higher scores mean a worse outcome.
The BFMDS is a functional marker consisting of parental- or self-reported daily activities (involving speech, handwriting,feeding, eating, swallowing, hygiene, dressing, and walking),with scores ranging from 0 (completely independent) to 30 (completely dependent).
Time Frame
Five days
10. Eligibility
Sex
Male
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Primary dystonia
Exclusion Criteria:
None
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jianhua Feng
Phone
89713749
Ext
0571
Email
380028654@qq.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jianhua Feng
Organizational Affiliation
Zhejiang University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Zhejiang University
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jianhua Feng
Phone
89713749
Ext
0571
Email
380028654@qq.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Precision-targeted Transcranial Magnetic Stimulation in the Treatment of Primary Dystonia
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