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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 : February 20, 2017
Sponsor:
Information provided by (Responsible Party):
University of Minnesota - Clinical and Translational Science Institute

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Treatment
Condition Focal Dystonia
Interventions Device: Repetitive Transcranial Magnetic Stimulation
Behavioral: Sensorimotor Retraining
Behavioral: Non-specific Therapy
Enrollment 9
Recruitment Details  
Pre-assignment Details  
Arm/Group Title rTMS + SMR, Then rTMS + CTL rTMS + CTL, Then rTMS + SMR
Hide Arm/Group Description

Repetitive transcranial magnetic stimulation and sensorimotor retraining

Repetitive Transcranial Magnetic Stimulation (Magstim): Applied to the premotor cortex at 1 Hz at 80% resting motor threshold for 1200 pulses.

Sensorimotor Retraining: For sensorimotor retraining, a subset of the Learning-based Sensorimotor Training program was followed

Repetitive transcranial magnetic stimulation (rTMS) with non-specific therapy that includes stretching, massage, range of motion

Repetitive Transcranial Magnetic Stimulation (Magstim): Applied to the premotor cortex at 1 Hz at 80% resting motor threshold for 1200 pulses.

Period Title: Overall Study
Started 5 4
Completed 4 4
Not Completed 1 0
Reason Not Completed
Lost to Follow-up             1             0
Arm/Group Title rTMS + Sensorimotor Retraining, rTMS + CTL rTMS + CTL, rTMS + Sensorimotor Retraining Total
Hide Arm/Group Description

Repetitive transcranial magnetic (rTMS) stimulation and sensorimotor retraining for the first phase, then rTMS with control therapy (CTL). CTL therapy was non-specific therapy that includes stretching, massage, range of motion.

Repetitive Transcranial Magnetic Stimulation (Magstim): Applied to the premotor cortex at 1 Hz at 80% resting motor threshold for 1200 pulses.

Sensorimotor Retraining: For sensorimotor retraining, a subset of the Learning-based Sensorimotor Training program was followed

Repetitive transcranial magnetic stimulation (rTMS) with control therapy (CTL). CTL therapy was non-specific therapy that includes stretching, massage, range of motion for the first phase, then rTMS with sensorimotor retraining.

Repetitive Transcranial Magnetic Stimulation (Magstim): Applied to the premotor cortex at 1 Hz at 80% resting motor threshold for 1200 pulses.

Total of all reporting groups
Overall Number of Baseline Participants 5 4 9
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 5 participants 4 participants 9 participants
48  (13.55359731) 44  (6.751543034) 46  (10.64320336)
Gender  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5 participants 4 participants 9 participants
Female
2
  40.0%
1
  25.0%
3
  33.3%
Male
3
  60.0%
3
  75.0%
6
  66.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 5 participants 4 participants 9 participants
5 4 9
1.Primary Outcome
Title Change From Baseline in Global Rating of Change at Posttest (Day 5)
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who completed the first phase were included in the analysis. Data were only analyzed in the first intervention period of the study because there was a lack of a washout effect between periods. This lack of washout made data from the second intervention period unreliable.
Arm/Group Title rTMS With Sensorimotor Retraining rTMS With Control Therapy
Hide Arm/Group Description:

Repetitive transcranial magnetic stimulation and sensorimotor retraining

Repetitive Transcranial Magnetic Stimulation (Magstim): Applied to the premotor cortex at 1 Hz at 80% resting motor threshold for 1200 pulses.

Sensorimotor Retraining: For sensorimotor retraining, a subset of the Learning-based Sensorimotor Training program was followed

Repetitive transcranial magnetic stimulation (rTMS) with non-specific therapy that includes stretching, massage, range of motion

Repetitive Transcranial Magnetic Stimulation (Magstim): Applied to the premotor cortex at 1 Hz at 80% resting motor threshold for 1200 pulses.

Overall Number of Participants Analyzed 5 4
Mean (Full Range)
Unit of Measure: units on a scale
1.3
(0 to 3)
1.2
(-4 to 3)
2.Secondary Outcome
Title Change From Baseline in Arm Dystonia Disability Scale at Posttest (Day 5)
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who completed the first phase were included in the analysis. Data were only analyzed in the first intervention period of the study because there was a lack of a washout effect between periods. This lack of washout made data from the second intervention period unreliable.
Arm/Group Title rTMS With Sensorimotor Retraining rTMS With Control Therapy
Hide Arm/Group Description:

Repetitive transcranial magnetic stimulation and sensorimotor retraining

Repetitive Transcranial Magnetic Stimulation (Magstim): Applied to the premotor cortex at 1 Hz at 80% resting motor threshold for 1200 pulses.

Sensorimotor Retraining: For sensorimotor retraining, a subset of the Learning-based Sensorimotor Training program was followed

Repetitive transcranial magnetic stimulation (rTMS) with non-specific therapy that includes stretching, massage, range of motion

Repetitive Transcranial Magnetic Stimulation (Magstim): Applied to the premotor cortex at 1 Hz at 80% resting motor threshold for 1200 pulses.

Overall Number of Participants Analyzed 5 4
Mean (Standard Deviation)
Unit of Measure: percentage of function
71.98  (7.031320694) 71.42  (8.464086657)
3.Secondary Outcome
Title Change From Baseline in Sensation at Posttest (Day 5)
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who completed the first phase were included in the analysis. Data were only analyzed in the first intervention period of the study because there was a lack of a washout effect between periods. This lack of washout made data from the second intervention period unreliable.
Arm/Group Title rTMS With Sensorimotor Retraining rTMS With Control Therapy
Hide Arm/Group Description:

Repetitive transcranial magnetic stimulation and sensorimotor retraining

Repetitive Transcranial Magnetic Stimulation (Magstim): Applied to the premotor cortex at 1 Hz at 80% resting motor threshold for 1200 pulses.

Sensorimotor Retraining: For sensorimotor retraining, a subset of the Learning-based Sensorimotor Training program was followed

Repetitive transcranial magnetic stimulation (rTMS) with non-specific therapy that includes stretching, massage, range of motion

Repetitive Transcranial Magnetic Stimulation (Magstim): Applied to the premotor cortex at 1 Hz at 80% resting motor threshold for 1200 pulses.

Overall Number of Participants Analyzed 5 4
Measure Type: Count of Participants
Unit of Measure: Participants
Improvement
3
  60.0%
2
  50.0%
No Change
2
  40.0%
1
  25.0%
Worsening
0
   0.0%
1
  25.0%
4.Secondary Outcome
Title Change From Baseline in Cortical Silent Period at Posttest (Day 5)
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who completed the first phase were included in the analysis. Data were only analyzed in the first intervention period of the study because there was a lack of a washout effect between periods. This lack of washout made data from the second intervention period unreliable.
Arm/Group Title rTMS With Sensorimotor Retraining rTMS With Control Therapy
Hide Arm/Group Description:

Repetitive transcranial magnetic stimulation and sensorimotor retraining

Repetitive Transcranial Magnetic Stimulation (Magstim): Applied to the premotor cortex at 1 Hz at 80% resting motor threshold for 1200 pulses.

Sensorimotor Retraining: For sensorimotor retraining, a subset of the Learning-based Sensorimotor Training program was followed

Repetitive transcranial magnetic stimulation (rTMS) with non-specific therapy that includes stretching, massage, range of motion

Repetitive Transcranial Magnetic Stimulation (Magstim): Applied to the premotor cortex at 1 Hz at 80% resting motor threshold for 1200 pulses.

Overall Number of Participants Analyzed 5 4
Measure Type: Count of Participants
Unit of Measure: Participants
Improvement
2
  40.0%
1
  25.0%
No Change
2
  40.0%
1
  25.0%
Worsening
1
  20.0%
2
  50.0%
5.Secondary Outcome
Title Change From Baseline for Pressure During Hand Writing at Posttest (Day 5)
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
One participant that did not display symptoms affecting handwriting and did not participate in the handwriting analysis. Data were only analyzed in the first intervention period of the study because there was a lack of a washout effect between periods. This lack of washout made data from the second intervention period unreliable.
Arm/Group Title rTMS With Sensorimotor Retraining rTMS With Control Therapy
Hide Arm/Group Description:

Repetitive transcranial magnetic stimulation and sensorimotor retraining

Repetitive Transcranial Magnetic Stimulation (Magstim): Applied to the premotor cortex at 1 Hz at 80% resting motor threshold for 1200 pulses.

Sensorimotor Retraining: For sensorimotor retraining, a subset of the Learning-based Sensorimotor Training program was followed

Repetitive transcranial magnetic stimulation (rTMS) with non-specific therapy that includes stretching, massage, range of motion

Repetitive Transcranial Magnetic Stimulation (Magstim): Applied to the premotor cortex at 1 Hz at 80% resting motor threshold for 1200 pulses.

Overall Number of Participants Analyzed 5 3
Measure Type: Count of Participants
Unit of Measure: Participants
Improvement
2
  40.0%
2
  66.7%
No Change
3
  60.0%
1
  33.3%
Worsening
0
   0.0%
0
   0.0%
6.Secondary Outcome
Title Change From Baseline for Physician Rated Impairment at Posttest (Day 5)
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who completed the first phase were included in the analysis. Data were only analyzed in the first intervention period of the study because there was a lack of a washout effect between periods. This lack of washout made data from the second intervention period unreliable.
Arm/Group Title rTMS With Sensorimotor Retraining rTMS With Control Therapy
Hide Arm/Group Description:

Repetitive transcranial magnetic stimulation and sensorimotor retraining

Repetitive Transcranial Magnetic Stimulation (Magstim): Applied to the premotor cortex at 1 Hz at 80% resting motor threshold for 1200 pulses.

Sensorimotor Retraining: For sensorimotor retraining, a subset of the Learning-based Sensorimotor Training program was followed

Repetitive transcranial magnetic stimulation (rTMS) with non-specific therapy that includes stretching, massage, range of motion

Repetitive Transcranial Magnetic Stimulation (Magstim): Applied to the premotor cortex at 1 Hz at 80% resting motor threshold for 1200 pulses.

Overall Number of Participants Analyzed 5 4
Measure Type: Count of Participants
Unit of Measure: Participants
Improvement
2
  40.0%
0
   0.0%
No Change
3
  60.0%
3
  75.0%
Worsening
0
   0.0%
1
  25.0%
7.Secondary Outcome
Title Change From Baseline in Physical Function at Posttest (Day 5)
Hide Description Participants completed the full SF-36 assessment with subsection of interest: “physical functioning”.
Time Frame Baseline and Posttest
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who completed the first phase were included in the analysis. Data were only analyzed in the first intervention period of the study because there was a lack of a washout effect between periods. This lack of washout made data from the second intervention period unreliable.
Arm/Group Title rTMS With Sensorimotor Retraining rTMS With Control Therapy
Hide Arm/Group Description:

Repetitive transcranial magnetic stimulation and sensorimotor retraining

Repetitive Transcranial Magnetic Stimulation (Magstim): Applied to the premotor cortex at 1 Hz at 80% resting motor threshold for 1200 pulses.

Sensorimotor Retraining: For sensorimotor retraining, a subset of the Learning-based Sensorimotor Training program was followed

Repetitive transcranial magnetic stimulation (rTMS) with non-specific therapy that includes stretching, massage, range of motion

Repetitive Transcranial Magnetic Stimulation (Magstim): Applied to the premotor cortex at 1 Hz at 80% resting motor threshold for 1200 pulses.

Overall Number of Participants Analyzed 5 4
Measure Type: Count of Participants
Unit of Measure: Participants
Improvement
1
  20.0%
0
   0.0%
No Change
4
  80.0%
2
  50.0%
Worsening
0
   0.0%
2
  50.0%
Time Frame Before and after each session of the intervention phase
Adverse Event Reporting Description Participants were evaluated per-sequence due to the lack of washout effect. Each participant was asked to identify if an event occurred immediately after and the beginning of each session throughout the study. A list of common side-effects was presented to each participant to report 'yes or no' to each side effect.
 
Arm/Group Title rTMS With Sensorimotor Retraining, Then rTMS With CTL rTMS With CTL, Then rTMS With Sensorimotor Retrain
Hide Arm/Group Description

Repetitive transcranial magnetic stimulation (rTMS) and sensorimotor retraining for first phase, then rTMS with control (CTL) therapy.

Repetitive Transcranial Magnetic Stimulation (Magstim): Applied to the premotor cortex at 1 Hz at 80% resting motor threshold for 1200 pulses.

Sensorimotor Retraining: For sensorimotor retraining, a subset of the Learning-based Sensorimotor Training program was followed

Repetitive transcranial magnetic stimulation (rTMS) with control (CTL) non-specific therapy that includes stretching, massage, range of motion for first phase, then rTMS with sensorimotor retraining for second phase.

Repetitive Transcranial Magnetic Stimulation (Magstim): Applied to the premotor cortex at 1 Hz at 80% resting motor threshold for 1200 pulses.

Sensorimotor Retraining: For sensorimotor retraining, a subset of the Learning-based Sensorimotor Training program was followed

All-Cause Mortality
rTMS With Sensorimotor Retraining, Then rTMS With CTL rTMS With CTL, Then rTMS With Sensorimotor Retrain
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
rTMS With Sensorimotor Retraining, Then rTMS With CTL rTMS With CTL, Then rTMS With Sensorimotor Retrain
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/5 (0.00%)      0/4 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
rTMS With Sensorimotor Retraining, Then rTMS With CTL rTMS With CTL, Then rTMS With Sensorimotor Retrain
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/5 (60.00%)      2/4 (50.00%)    
Musculoskeletal and connective tissue disorders     
Neck Pain *  0/5 (0.00%)  0 2/4 (50.00%)  2
Nervous system disorders     
Headache * [1]  0/5 (0.00%)  0 2/4 (50.00%)  8
Decreased balance * [2]  2/5 (40.00%)  2 0/4 (0.00%)  0
Psychiatric disorders     
Abnormal Sleep Pattern *  1/5 (20.00%)  2 0/4 (0.00%)  0
Mood change *  1/5 (20.00%)  1 0/4 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
[1]
Mild headache sometimes accompanied by dizziness
[2]
Feeling dizzy, off-balance
Small sample size may have underpowered the study. The high variance seen in our single subject analysis is not unusual as a current conundrum in neuromodulation is the variable response between subjects to many different types of neuromodulation.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Dr. Teresa Kimberley
Organization: University of Minnesota
Phone: 612-626-4096
EMail: tjk@umn.edu
Responsible Party: University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier: NCT01738581     History of Changes
Other Study ID Numbers: DSS0608M91226
First Submitted: September 18, 2012
First Posted: November 30, 2012
Results First Submitted: May 19, 2015
Results First Posted: June 28, 2016
Last Update Posted: February 20, 2017