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rTMS and Retraining in Focal Hand Dystonia (DSS)

Primary Purpose

Focal Dystonia

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Repetitive Transcranial Magnetic Stimulation
Sensorimotor Retraining
Non-specific Therapy
Sponsored by
University of Minnesota
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Focal Dystonia focused on measuring focal hand dystonia (FHD), repetitive transcranial magnetic stimulation (rTMS), sensorimotor retraining

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Minnesota, Program in Physical Therapy
  • Program in Physical Therapy, University of Minnesota

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

rTMS + SMR, then rTMS + CTL

rTMS + CTL, then rTMS + SMR

Arm Description

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).

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).

Outcomes

Primary Outcome Measures

Change From Baseline in Global Rating of Change at Posttest (Day 5)
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

Change From Baseline in Arm Dystonia Disability Scale at Posttest (Day 5)
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)
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)
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)
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)
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)
Participants completed the full SF-36 assessment with subsection of interest: "physical functioning".

Full Information

First Posted
September 18, 2012
Last Updated
October 30, 2019
Sponsor
University of Minnesota
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1. Study Identification

Unique Protocol Identification Number
NCT01738581
Brief Title
rTMS and Retraining in Focal Hand Dystonia
Acronym
DSS
Official Title
Effectiveness of rTMS and Retraining in the Treatment of Focal Hand Dystonia
Study Type
Interventional

2. Study Status

Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
November 2011 (undefined)
Primary Completion Date
June 2015 (Actual)
Study Completion Date
June 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Minnesota

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Focal Dystonia
Keywords
focal hand dystonia (FHD), repetitive transcranial magnetic stimulation (rTMS), sensorimotor retraining

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Crossover Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
9 (Actual)

8. Arms, Groups, and Interventions

Arm Title
rTMS + SMR, then rTMS + CTL
Arm Type
Experimental
Arm Description
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).
Arm Title
rTMS + CTL, then rTMS + SMR
Arm Type
Experimental
Arm Description
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).
Intervention Type
Device
Intervention Name(s)
Repetitive Transcranial Magnetic Stimulation
Other Intervention Name(s)
Magstim stimulator (Magstim Co. LTD, Whitland,UK), Neuromodulation
Intervention Description
Applied to the premotor cortex at 1 Hz at 90% resting motor threshold for 1200 pulses.
Intervention Type
Behavioral
Intervention Name(s)
Sensorimotor Retraining
Other Intervention Name(s)
Learning-based Sensorimotor Training program,, Sensory and motor Retraining
Intervention Description
For sensorimotor retraining, a subset of the Learning-based Sensorimotor Training program was followed
Intervention Type
Behavioral
Intervention Name(s)
Non-specific Therapy
Other Intervention Name(s)
Massage, Stretching
Intervention Description
A non-specific massage and stretching program directed to the hand, wrist and forearm
Primary Outcome Measure Information:
Title
Change From Baseline in Global Rating of Change at Posttest (Day 5)
Description
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).
Time Frame
Baseline and Posttest
Secondary Outcome Measure Information:
Title
Change From Baseline in Arm Dystonia Disability Scale at Posttest (Day 5)
Description
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.
Time Frame
Baseline and Posttest
Title
Change From Baseline in Sensation at Posttest (Day 5)
Description
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).
Time Frame
Baseline and Posttest
Title
Change From Baseline in Cortical Silent Period at Posttest (Day 5)
Description
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
Time Frame
Baseline and Posttest
Title
Change From Baseline for Pressure During Hand Writing at Posttest (Day 5)
Description
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.
Time Frame
Baseline and Posttest
Title
Change From Baseline for Physician Rated Impairment at Posttest (Day 5)
Description
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.
Time Frame
Baseline and Posttest
Title
Change From Baseline in Physical Function at Posttest (Day 5)
Description
Participants completed the full SF-36 assessment with subsection of interest: "physical functioning".
Time Frame
Baseline and Posttest

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Teresa J Kimberley, PhD, PT
Organizational Affiliation
University of Minnesota, Program in Physical Therapy
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Minnesota, Program in Physical Therapy
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55414
Country
United States
Facility Name
Program in Physical Therapy, University of Minnesota
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
14586919
Citation
Byl NN, Nagajaran S, McKenzie AL. Effect of sensory discrimination training on structure and function in patients with focal hand dystonia: a case series. Arch Phys Med Rehabil. 2003 Oct;84(10):1505-14. doi: 10.1016/s0003-9993(03)00276-4.
Results Reference
background
PubMed Identifier
23340117
Citation
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.
Results Reference
background
PubMed Identifier
26217209
Citation
Kimberley TJ, Schmidt RL, Chen M, Dykstra DD, Buetefisch CM. Mixed effectiveness of rTMS and retraining in the treatment of focal hand dystonia. Front Hum Neurosci. 2015 Jul 9;9:385. doi: 10.3389/fnhum.2015.00385. eCollection 2015.
Results Reference
result

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rTMS and Retraining in Focal Hand Dystonia

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