rTMS and Retraining in Focal Hand Dystonia (DSS)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier:
NCT01738581
First received: September 18, 2012
Last updated: May 19, 2016
Last verified: May 2016
  Purpose
This study is exploring a new experimental procedure in dystonia called repetitive transcranial magnetic brain stimulation (TMS) combined with rehabilitation. The purpose of the study is to determine whether repetitive TMS is effective as a treatment to reduce symptoms in dystonia as demonstrated by improved motor performance.

Condition Intervention Phase
Focal Dystonia
Device: Repetitive Transcranial Magnetic Stimulation
Behavioral: Sensorimotor Retraining
Behavioral: Non-specific Therapy
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effectiveness of rTMS and Retraining in the Treatment of Focal Hand Dystonia

Resource links provided by NLM:


Further study details as provided by University of Minnesota - Clinical and Translational Science Institute:

Primary Outcome Measures:
  • Global Rating of Change [ Time Frame: Assessed 1 day post-treatment ] [ Designated as safety issue: No ]
    Symptom severity was assessed using the global rating of change (GROC). For the GROC, participants were asked to identify between one to three functions most impacted by focal hand dystonia. At posttest 1 they were then asked to select a rating of perceived change that represented the level of function compared to baseline. Perceived change consisted of a ±7 point Likert scale (+7= a very great deal better, 0= no change, -7= a very great deal worse).


Secondary Outcome Measures:
  • Arm Dystonia Disability Scale [ Time Frame: Assessed 1 day post-treatment ] [ Designated as safety issue: No ]
    The Arm Dystonia Disability Scale (ADDS) is adapted from previous work (Fahn, 1989) where participants completed as survey of task difficulty for activities such as writing, handling utensils, and buttoning on a scale of 1-4 (1 = no difficulty ,4 = not able or marked difficulty). This is a subjective assessment of impairment due to focal hand dystonia. Scores are determined using an equation: total points scored, divided by the maximum possible (23), multiplied by the quotient by 90 and subtract from 90%. Scores range from 0%-90% with higher scores indicating more function


Enrollment: 9
Study Start Date: November 2011
Study Completion Date: June 2015
Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Sensorimotor retraining with rTMS
Repetitive transcranial magnetic stimulation and sensorimotor retraining
Device: Repetitive Transcranial Magnetic Stimulation
Applied to the premotor cortex at 1 Hz at 90% resting motor threshold for 1200 pulses.
Other Names:
  • Magstim stimulator (Magstim Co. LTD, Whitland,UK)
  • Neuromodulation
Behavioral: Sensorimotor Retraining
For sensorimotor retraining, a subset of the Learning-based Sensorimotor Training program was followed
Other Names:
  • Learning-based Sensorimotor Training program,
  • Sensory and motor Retraining
Active Comparator: Non-specific therapy with rTMS
Repetitive transcranial magnetic stimulation (rTMS) with non-specific therapy that includes stretching, massage, range of motion
Device: Repetitive Transcranial Magnetic Stimulation
Applied to the premotor cortex at 1 Hz at 90% resting motor threshold for 1200 pulses.
Other Names:
  • Magstim stimulator (Magstim Co. LTD, Whitland,UK)
  • Neuromodulation
Behavioral: Non-specific Therapy
A non-specific massage and stretching program directed to the hand, wrist and forearm
Other Names:
  • Massage
  • Stretching

Detailed Description:

BACKGROUND: Though the etiology of focal hand dystonia (FHD) is uncertain, two primary factors implicated in the development of dystonic symptoms are excessive cortical excitability and impaired sensorimotor processing.

OBJECTIVE: The purpose of this study was to determine the functional efficacy and neural effects of a Dual intervention of rTMS and sensorimotor retraining. Our working hypothesis is: subjects receiving the combined intervention will (1) display significantly improved handwriting measures; (2) report significant improvement in daily functional ability; (3) display reduced hand cramping compared; and (4) demonstrate reduced corticospinal excitability after the Dual intervention when compared to the rTMS+ stretching and massage (Sham) intervention.

METHODS: A randomized, single-subject, multiple baseline design with crossover is used for this study that will examine ten subjects with FHD with two interventions: five days of low-frequency 1 Hz rTMS + sensorimotor retraining (Dual intervention) vs. rTMS + stretching and massage (Sham). The rTMS is applied to the premotor cortex at 1 Hz at 90% resting motor threshold for 1200 pulses. For sensorimotor retraining, a subset of the Learning-based Sensorimotor Training program was followed.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Greater than 18 years of age
  • Symptoms of focal hand dystonia or writer's cramp

Exclusion Criteria:

  • History of seizure or other neurologic disorder
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01738581

Locations
United States, Minnesota
University of Minnesota, Program in Physical Therapy
Minneapolis, Minnesota, United States, 55414
Program in Physical Therapy, University of Minnesota
Minneapolis, Minnesota, United States, 55455
Sponsors and Collaborators
University of Minnesota - Clinical and Translational Science Institute
Investigators
Principal Investigator: Teresa J Kimberley, PhD, PT University of Minnesota, Program in Physical Therapy
  More Information

Publications:
Responsible Party: University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier: NCT01738581     History of Changes
Other Study ID Numbers: DSS0608M91226 
Study First Received: September 18, 2012
Results First Received: May 19, 2015
Last Updated: May 19, 2016
Health Authority: United States: Institutional Review Board
Individual Participant Data  
Plan to Share IPD: No

Keywords provided by University of Minnesota - Clinical and Translational Science Institute:
focal hand dystonia (FHD)
repetitive transcranial magnetic stimulation (rTMS)
sensorimotor retraining

Additional relevant MeSH terms:
Dystonia
Dystonic Disorders
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Movement Disorders
Central Nervous System Diseases

ClinicalTrials.gov processed this record on July 25, 2016