rTMS and Retraining in Focal Hand Dystonia
DSS
Effectiveness of rTMS and Retraining in the Treatment of Focal Hand Dystonia
1 other identifier
interventional
9
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Nov 2011
Typical duration for phase_1
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2011
CompletedFirst Submitted
Initial submission to the registry
September 18, 2012
CompletedFirst Posted
Study publicly available on registry
November 30, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2015
CompletedResults Posted
Study results publicly available
June 28, 2016
CompletedNovember 18, 2019
October 1, 2019
3.6 years
September 18, 2012
May 19, 2015
October 30, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (6)
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
- +1 more secondary outcomes
Study Arms (2)
rTMS + SMR, then rTMS + CTL
EXPERIMENTALFirst 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).
rTMS + CTL, then rTMS + SMR
EXPERIMENTALFirst 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
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
A non-specific massage and stretching program directed to the hand, wrist and forearm
Eligibility Criteria
You may qualify if:
- Greater than 18 years of age
- Symptoms of focal hand dystonia or writer's cramp
You may not qualify if:
- History of seizure or other neurologic disorder
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
University of Minnesota, Program in Physical Therapy
Minneapolis, Minnesota, 55414, United States
Program in Physical Therapy, University of Minnesota
Minneapolis, Minnesota, 55455, United States
Related Publications (3)
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.
PMID: 14586919BACKGROUNDKimberley 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.
PMID: 23340117BACKGROUNDKimberley 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.
PMID: 26217209RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
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.
Results Point of Contact
- Title
- Dr. Teresa Kimberley
- Organization
- University of Minnesota
Study Officials
- PRINCIPAL INVESTIGATOR
Teresa J Kimberley, PhD, PT
University of Minnesota, Program in Physical Therapy
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 18, 2012
First Posted
November 30, 2012
Study Start
November 1, 2011
Primary Completion
June 1, 2015
Study Completion
June 1, 2015
Last Updated
November 18, 2019
Results First Posted
June 28, 2016
Record last verified: 2019-10
Data Sharing
- IPD Sharing
- Will not share