rTMS and Retraining in Focal Hand Dystonia (DSS)

University of Minnesota (UMN)

Status and phase: Completed; Phase 2; Phase 1

Conditions: Focal Dystonia

Treatments: Behavioral: Sensorimotor Retraining; Device: Repetitive Transcranial Magnetic Stimulation; Behavioral: Non-specific Therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT01738581

0608M91226-2

Details and patient eligibility

About

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.

Full 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.

Enrollment: 9 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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9 participants in 2 patient groups

rTMS + SMR, then rTMS + CTL

Experimental group

Description:

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).

Treatment:

Behavioral: Non-specific Therapy

Device: Repetitive Transcranial Magnetic Stimulation

Behavioral: Sensorimotor Retraining

rTMS + CTL, then rTMS + SMR

Experimental group

Description:

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).

Treatment:

Behavioral: Non-specific Therapy

Device: Repetitive Transcranial Magnetic Stimulation

Behavioral: Sensorimotor Retraining