NCT01884064

Brief Summary

This study investigated the short term effects of repeated administrations of repetitive-transcranial magnetic stimulation (rTMS) on clinical changes and investigate neurophysiologic responses to rTMS of the activated motor system in patients with FHD.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
17

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Jul 2008

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
completed

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

July 1, 2008

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2010

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

June 20, 2012

Completed
1 year until next milestone

First Posted

Study publicly available on registry

June 21, 2013

Completed
2.4 years until next milestone

Results Posted

Study results publicly available

November 2, 2015

Completed
Last Updated

June 17, 2016

Status Verified

May 1, 2016

Enrollment Period

2 years

First QC Date

June 20, 2012

Results QC Date

August 17, 2015

Last Update Submit

May 13, 2016

Conditions

Dystonia, Focal, Task-specific

Keywords

focal hand dystoniarehabilitationrTMSwriter's crampclinical

Outcome Measures

Primary Outcomes (1)

  • Cortical Silent Period

    Subjects performed an isometric abduction contraction of the index finger against a strain gauge coupled to a load cell. A single TMS pulse was applied 2-3 s after contraction initiation and subjects were instructed to relax 2-3 s after stimulation. The duration of the CSP was measured on a trial-by-trial basis and was delineated by the first superimposed TMS-evoked EMG spike (onset) and the return of activity to 50% of prestimulus EMG signal (offset). The mean CSP duration was calculated for each block of measurements. The duration of CSP is thought to be related to intracortical GABAergic synapse-mediated inhibition in the stimulated cortical region. Measures of CSP have been shown to be reliable in repeated measures studies to determine an effect of intervention within a group of subjects (Orth and Rothwell 2004; Borich et al., 2009). Values are calculated as the value recorded at the latest time minus the earliest time point.

    Baseline and Day 5

Study Arms (2)

inhibitory rTMS

EXPERIMENTAL

Repetitive Transcranial Magnetic stimulation: 1 Hz rTMS, 1800 pulses, delivered to premotor cortex. Patients held a pencil and made movements that did not elicit dystonic symptoms during rTMS. Intervention was delivered every day for 5 days.

Device: rTMS

Sham rTMS

PLACEBO COMPARATOR

Sham Repetitive Transcranial Magnetic stimulation: 1 Hz rTMS, 1800 pulses, delivered to premotor cortex. Patients held a pencil and made movements that did not elicit dystonic symptoms during rTMS. Intervention was delivered every day for 5 days.

Device: Sham rTMS

Interventions

rTMSDEVICE

rTMS

Also known as: Magstim Rapid 2, Magstim Co, Whitland Dyfed, UK
inhibitory rTMS
Sham rTMSDEVICE

Sham rTMS

Also known as: Placebo Magstim Rapid 2, Magstim Co, Whitland Dyfed, UK
Sham rTMS

Eligibility Criteria

Age21 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Task specific Focal Hand Dystonia

You may not qualify if:

  • any neurologic condition other than FHD
  • medication for dystonia
  • botulinum toxin within the past three months
  • seizure history
  • pregnancy
  • implanted medical devices

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Program in Physical Therapy, University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

Related Publications (1)

  • Kimberley TJ, Borich MR, Arora S, Siebner HR. Multiple sessions of low-frequency repetitive transcranial magnetic stimulation in focal hand dystonia: clinical and physiological effects. Restor Neurol Neurosci. 2013;31(5):533-42. doi: 10.3233/RNN-120259.

    PMID: 23340117RESULT

MeSH Terms

Conditions

Dystonia, Focal, Task-SpecificDystonic Disorders

Condition Hierarchy (Ancestors)

Movement DisordersCentral Nervous System DiseasesNervous System Diseases

Limitations and Caveats

In this preliminary study, there were subjects with different types of hand dystonia and large range of symptom duration. An ideal study would have sufficient n to be able to stratify subjects within various groups.

Results Point of Contact

Title
Dr. Teresa Jacobson Kimberley
Organization
University of Minnesota
tjk@umn.edu
612-626-4096

Study Officials

  • Teresa J Kimberley, PhD, PT

    University of Minnesota

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 20, 2012

First Posted

June 21, 2013

Study Start

July 1, 2008

Primary Completion

July 1, 2010

Study Completion

July 1, 2010

Last Updated

June 17, 2016

Results First Posted

November 2, 2015

Record last verified: 2016-05

Data Sharing

IPD Sharing
Will not share

Locations

US(1)