NCT01738581

rTMS and Retraining in Focal Hand Dystonia

Effectiveness of rTMS and Retraining in the Treatment of Focal Hand Dystonia

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 9 (actual)
• Sponsor: University of Minnesota · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Focal Dystonia

Interventions

Type	Name	Description
DEVICE	Repetitive Transcranial Magnetic Stimulation	Applied to the premotor cortex at 1 Hz at 90% resting motor threshold for 1200 pulses.
BEHAVIORAL	Sensorimotor Retraining	For sensorimotor retraining, a subset of the Learning-based Sensorimotor Training program was followed
BEHAVIORAL	Non-specific Therapy	A non-specific massage and stretching program directed to the hand, wrist and forearm

Timeline

• Start date: 2011-11-01
• Primary completion: 2015-06-01
• Completion: 2015-06-01
• First posted: 2012-11-30
• Last updated: 2019-11-18
• Results posted: 2016-06-28

Locations

2 sites across 1 country: United States