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rTMS and Retraining in Focal Hand Dystonia (DSS)

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ClinicalTrials.gov Identifier: NCT01738581
Recruitment Status : Completed
First Posted : November 30, 2012
Results First Posted : June 28, 2016
Last Update Posted : November 18, 2019
Sponsor:
Information provided by (Responsible Party):
University of Minnesota

Tracking Information
First Submitted Date  ICMJE September 18, 2012
First Posted Date  ICMJE November 30, 2012
Results First Submitted Date  ICMJE May 19, 2015
Results First Posted Date  ICMJE June 28, 2016
Last Update Posted Date November 18, 2019
Study Start Date  ICMJE November 2011
Actual Primary Completion Date June 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 30, 2016)
Change From Baseline in Global Rating of Change at Posttest (Day 5) [ Time Frame: Baseline and Posttest ]
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).
Original Primary Outcome Measures  ICMJE
 (submitted: November 29, 2012)
Change from baseline in hand writing assessment [ Time Frame: Day 8, 9 and 14 ]
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.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 30, 2016)
  • Change From Baseline in Arm Dystonia Disability Scale at Posttest (Day 5) [ Time Frame: Baseline and Posttest ]
    The Arm Dystonia Disability Scale (ADDS) is a survey where participants rate 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.
  • Change From Baseline in Sensation at Posttest (Day 5) [ Time Frame: Baseline and Posttest ]
    Examinations included two point discrimination. Two-point discrimination threshold was completed using a Disk-Criminator™. Participants were asked to reply "one" or "two" after each presentation. Static and dynamic stimuli were presented to the index and ring fingers bilaterally, meaning it was presented as a static stimuli or it was slowly swept across the skin (dynamic).
  • Change From Baseline in Cortical Silent Period at Posttest (Day 5) [ Time Frame: Baseline and Posttest ]
    Cortical silent period (CSP) testing was completed during an isometric contraction of the target muscle whereby the motor evoked potential is followed by a short duration of electromyographic quiescence. The maximal voluntary contraction for finger abduction was recorded using a custom strain gauge placed around the index finger. Real-time visual feedback was given on a laptop screen to project the force produced by the participant and 20% of the maximum of three trials was calculated and displayed on a target line. For the CSP, participants were asked to contract until the target line was met, then a single transcranial magnetic stimulation pulse was delivered to the motor cortex. Ten trials were collected with a short rest period to prevent fatigue. CSP duration was calculated in milliseconds (ms). CSP EMG data were first rectified, and then a 10-ms moving average calculation was applied to the data. The onset of the CSP was set as the time point of the delivery of the TM
  • Change From Baseline for Pressure During Hand Writing at Posttest (Day 5) [ Time Frame: Baseline and Posttest ]
    Digitized handwriting was assessed using a computerized tablet (WACOM Co., Ltd., japan) with MovAlyzeR® (Neuroscript LLC, Tempe, AZ) hardware and software. Participants used a custom modified digitized pen (Kiko Software, Netherlands) to write in a self-selected pace and style on the tablet with real-time visual feedback. Writing tasks included "My country tis of thee" at a self-selected pace, repeated eight times. Data were sampled at 215 Hz (resolution: 5080 lpi, accuracy: ±0.01 pressure range: 0-800 g). Writing samples were segmented by points of minimal velocity into single strokes for analysis. Pressure for each stroke was automatically calculated within the software.
  • Change From Baseline for Physician Rated Impairment at Posttest (Day 5) [ Time Frame: Baseline and Posttest ]
    Video recordings were made as participants wrote on a pad of paper with pen. Participants were asked to draw a series of 10 loops across the pad of paper followed by "The dog is barking" and their signature, each repeated four times. A physician blinded to participant allocation rated recordings. Scoring criteria were adapted from a standardized writer's cramp rating scale (WCRS) (Wissel et al., 1996), rating pathological flexion or extension at the wrist, fingers and elbow, presence of tremor, dystonic posture, writing speed and latency of dystonic symptoms. Final scores are expressed as a rating listed as a movement score.
  • Change From Baseline in Physical Function at Posttest (Day 5) [ Time Frame: Baseline and Posttest ]
    Participants completed the full SF-36 assessment with subsection of interest: "physical functioning".
Original Secondary Outcome Measures  ICMJE
 (submitted: November 29, 2012)
  • Change from baseline in cortical excitability testing [ Time Frame: Day 8, 9 and 14 ]
    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 ]
  • Change from baseline in scale of self-rated improvement [ Time Frame: Day 8 and Day 14 ]
  • Change from baseline in graphesthesia and stereognosis testing [ Time Frame: Day 8 and Day 14 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE rTMS and Retraining in Focal Hand Dystonia
Official Title  ICMJE Effectiveness of rTMS and Retraining in the Treatment of Focal Hand Dystonia
Brief Summary 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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Focal Dystonia
Intervention  ICMJE
  • 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
  • Behavioral: Non-specific Therapy
    A non-specific massage and stretching program directed to the hand, wrist and forearm
    Other Names:
    • Massage
    • Stretching
Study Arms  ICMJE
  • Experimental: rTMS + SMR, then rTMS + CTL
    First phase of treatment: Repetitive transcranial magnetic stimulation (rTMS) and sensorimotor retraining (SMR). Second phase of treatment: rTMS and control treatment (CTL) (CTL therapy consisted of non-specific therapy that includes stretching, massage, range of motion).
    Interventions:
    • Device: Repetitive Transcranial Magnetic Stimulation
    • Behavioral: Sensorimotor Retraining
    • Behavioral: Non-specific Therapy
  • Experimental: rTMS + CTL, then rTMS + SMR
    First phase of treatment: Repetitive transcranial magnetic stimulation (rTMS) with non-specific therapy that includes stretching, massage, range of motion. Second phase of treatment: rTMS and sensorimotor retraining (SMR).
    Interventions:
    • Device: Repetitive Transcranial Magnetic Stimulation
    • Behavioral: Sensorimotor Retraining
    • Behavioral: Non-specific Therapy
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 6, 2014)
9
Original Estimated Enrollment  ICMJE
 (submitted: November 29, 2012)
10
Actual Study Completion Date  ICMJE June 2015
Actual Primary Completion Date June 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01738581
Other Study ID Numbers  ICMJE 0608M91226-2
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party University of Minnesota
Study Sponsor  ICMJE University of Minnesota
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Teresa J Kimberley, PhD, PT University of Minnesota, Program in Physical Therapy
PRS Account University of Minnesota
Verification Date October 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP