Dystonia Synergistic Intervention (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: February 6, 2014
Last verified: February 2014
  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 (Magstim)
Behavioral: Sensorimotor Retraining
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Determining the Efficacy of Synergistic Intervention With rTMS and Sensorimotor Retraining

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Change from baseline in hand writing assessment [ Time Frame: Day 8, 9 and 14 ] [ Designated as safety issue: No ]

    Hand writing assessment of pressure, fluency, velocity, etc is the significant limitation for patients with hand dystonia.

    The efficacy of the intervention is tested with with digitized table assessment of handwriting and the outcome measure is change from baseline.



Secondary Outcome Measures:
  • Change from baseline in cortical excitability testing [ Time Frame: Day 8, 9 and 14 ] [ Designated as safety issue: No ]
    Cortical excitability measures are measured by transcranial magnetic stimulation including cortical silent period, short interval cortical inhibition, intracortical facilitation, and stimulus-response curve.

  • Change from baseline in hand dystonia assessment [ Time Frame: Day 8 and Day 14 ] [ Designated as safety issue: No ]
  • Change from baseline in scale of self-rated improvement [ Time Frame: Day 8 and Day 14 ] [ Designated as safety issue: No ]
  • Change from baseline in graphesthesia and stereognosis testing [ Time Frame: Day 8 and Day 14 ] [ Designated as safety issue: No ]

Enrollment: 9
Study Start Date: November 2011
Study Completion Date: September 2013
Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Dual Training
Repetitive transcranial magnetic stimulation and sensorimotor retraining
Device: Repetitive Transcranial Magnetic Stimulation (Magstim)
Applied to the premotor cortex at 1 Hz at 90% resting motor threshold for 1200 pulses.
Other Names:
  • flat figure-of-eight 70-mm diameter coil connected to a Magstim rapid magnetic
  • stimulator (Magstim Co. LTD, Whitland,UK)
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: Tradition therapy with rTMS
Repetitive transcranial magnetic stimulation (rTMS) with traditional physical therapy that includes stretching, massage, range of motion
Device: Repetitive Transcranial Magnetic Stimulation (Magstim)
Applied to the premotor cortex at 1 Hz at 90% resting motor threshold for 1200 pulses.
Other Names:
  • flat figure-of-eight 70-mm diameter coil connected to a Magstim rapid magnetic
  • stimulator (Magstim Co. LTD, Whitland,UK)

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

Locations
United States, Minnesota
Program in Physical Therapy, University of Minnesota
Minneapolis, Minnesota, United States, 55455
University of Minnesota, Program in Physical Therapy
Minneapolis, Minnesota, United States, 55414
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

No publications provided

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
Last Updated: February 6, 2014
Health Authority: United States: Institutional Review Board

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 April 21, 2014