NCT01738581|CompletedPhase 1/2ResultsDMC
rTMS and Retraining in Focal Hand Dystonia
DSS
Effectiveness of rTMS and Retraining in the Treatment of Focal Hand Dystonia
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Sponsor study identifier
interventional
9
1 country
2
Study Start
November 2011
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
June 2015
Actual (reported)Study Completion
June 2015
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 2015
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
November 2011
Date type not reportedThis date has not been verified as actual or estimated.
September 18, 2012
Actual (reported)November 30, 2012
Actual (reported)June 2015
Actual (reported)June 2015
Actual (reported)June 28, 2016
Actual (reported)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).
Baseline and Posttest
Change From Baseline in Arm Dystonia Disability Scale at Posttest (Day 5)
Baseline and Posttest
Change From Baseline in Sensation at Posttest (Day 5)
Baseline and Posttest
Change From Baseline in Cortical Silent Period at Posttest (Day 5)
Baseline and Posttest
Change From Baseline for Pressure During Hand Writing at Posttest (Day 5)
Baseline and Posttest
Change From Baseline for Physician Rated Impairment at Posttest (Day 5)
Baseline and Posttest
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).
Applied to the premotor cortex at 1 Hz at 90% resting motor threshold for 1200 pulses.
University of Minnesota, Program in Physical Therapy
Minneapolis, Minnesota, 55414, United States
Program in Physical Therapy, University of Minnesota
Minneapolis, Minnesota, 55455, United States
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.
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.
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.
Teresa J Kimberley, PhD, PT
University of Minnesota, Program in Physical Therapy
9 participants (actual enrollment reported by the registry).
First Submitted
September 18, 2012
First Posted
November 30, 2012
Study Start
November 2011
Date type not reportedThis date has not been verified as actual or estimated.
EEG and EMG Studies of Hand Dystonia
Oral Zinc Supplementation to Enhance Botulinum Neurotoxin Response
For sensorimotor retraining, a subset of the Learning-based Sensorimotor Training program was followed
A non-specific massage and stretching program directed to the hand, wrist and forearm
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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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.
Primary Completion
June 2015
Actual (reported)Study Completion
June 2015
Actual (reported)Last Updated
November 18, 2019
Results First Posted
June 28, 2016
Record last verified: 2019-10
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Source: ClinicalTrials.gov.
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