NCT04727177

Brief Summary

In this scheme, TMS treatment of Primary dystonia is planned by precise magnetic resonance positioning.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1

participants targeted

Target at below P25 for early_phase_1

Timeline
Completed

Started Nov 2020

Shorter than P25 for early_phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2020

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

January 24, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 27, 2021

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2021

Completed
Last Updated

March 19, 2021

Status Verified

January 1, 2021

Enrollment Period

5 months

First QC Date

January 24, 2021

Last Update Submit

March 16, 2021

Conditions

Primary DystoniaTranscranial Magnetic Stimulation

Outcome Measures

Primary Outcomes (1)

  • 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).

    Five days

Interventions

Transcranial magnetic stimulationDEVICE

Transcranial magnetic stimulation (TMS) is a noninvasive biological stimulation technique born in the middle of 1980's.

Eligibility Criteria

Sexmale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Primary dystonia

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zhejiang University

Hangzhou, Zhejiang, 310000, China

RECRUITING

MeSH Terms

Conditions

Dystonic Disorders

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Movement DisordersCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

Magnetic Field TherapyTherapeutics

Study Officials

  • Jianhua Feng

    Zhejiang University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jianhua Feng

CONTACT

89713749380028654@qq.com

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NA
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 24, 2021

First Posted

January 27, 2021

Study Start

November 1, 2020

Primary Completion

April 1, 2021

Study Completion

May 1, 2021

Last Updated

March 19, 2021

Record last verified: 2021-01

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)