Clinical trial NCT01738581: rTMS and Retraining in Focal Hand Dystonia
Official title: Effectiveness of rTMS and Retraining in the Treatment of Focal Hand Dystonia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Focal Dystonia
Keywords: focal hand dystonia (FHD)
repetitive transcranial magnetic stimulation (rTMS)
sensorimotor retraining
Lead sponsor: University of Minnesota
Sponsor class: OTHER
First posted: 2012-11-30
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change From Baseline in Global Rating of Change at Posttest (Day 5)
timeFrame: Baseline and Posttest
Secondary outcomes:
measure: Change From Baseline in Arm Dystonia Disability Scale at Posttest (Day 5)
timeFrame: Baseline and Posttest
measure: Change From Baseline in Sensation at Posttest (Day 5)
timeFrame: Baseline and Posttest
measure: Change From Baseline in Cortical Silent Period at Posttest (Day 5)
timeFrame: Baseline and Posttest
measure: Change From Baseline for Pressure During Hand Writing at Posttest (Day 5)
timeFrame: Baseline and Posttest
measure: Change From Baseline for Physician Rated Impairment at Posttest (Day 5)
timeFrame: Baseline and Posttest
measure: Change From Baseline in Physical Function at Posttest (Day 5)
timeFrame: Baseline and Posttest
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota, Program in Physical Therapy
state: Minnesota
city: Minneapolis
country: United States
facility: Program in Physical Therapy, University of Minnesota
state: Minnesota
Study officials:
affiliation: University of Minnesota, Program in Physical Therapy
name: Teresa J Kimberley, PhD, PT
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.