rTMS and Retraining in Focal Hand Dystonia

NCT ID: NCT01738581

Last Updated: 2019-11-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 9 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-11-30
• Study Completion Date: 2015-06-30

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.

Conditions

Focal Dystonia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

rTMS + SMR, then rTMS + CTL

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).

Group Type: EXPERIMENTAL

Repetitive Transcranial Magnetic Stimulation

Intervention Type: DEVICE

Applied to the premotor cortex at 1 Hz at 90% resting motor threshold for 1200 pulses.

Sensorimotor Retraining

Intervention Type: BEHAVIORAL

For sensorimotor retraining, a subset of the Learning-based Sensorimotor Training program was followed

Non-specific Therapy

Intervention Type: BEHAVIORAL

A non-specific massage and stretching program directed to the hand, wrist and forearm

rTMS + CTL, then rTMS + SMR

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).

Group Type: EXPERIMENTAL

Repetitive Transcranial Magnetic Stimulation

Intervention Type: DEVICE

Applied to the premotor cortex at 1 Hz at 90% resting motor threshold for 1200 pulses.

Sensorimotor Retraining

Intervention Type: BEHAVIORAL

For sensorimotor retraining, a subset of the Learning-based Sensorimotor Training program was followed

Non-specific Therapy

Intervention Type: BEHAVIORAL

A non-specific massage and stretching program directed to the hand, wrist and forearm

Interventions

Repetitive Transcranial Magnetic Stimulation

Applied to the premotor cortex at 1 Hz at 90% resting motor threshold for 1200 pulses.

Intervention Type: DEVICE

Sensorimotor Retraining

For sensorimotor retraining, a subset of the Learning-based Sensorimotor Training program was followed

Intervention Type: BEHAVIORAL

Non-specific Therapy

A non-specific massage and stretching program directed to the hand, wrist and forearm

Intervention Type: BEHAVIORAL

Other Intervention Names

Magstim stimulator (Magstim Co. LTD, Whitland,UK); Neuromodulation; Learning-based Sensorimotor Training program,; Sensory and motor Retraining; Massage; Stretching

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Minnesota

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Teresa J Kimberley, PhD, PT

Role: PRINCIPAL_INVESTIGATOR

University of Minnesota, Program in Physical Therapy

Locations

University of Minnesota, Program in Physical Therapy

Minneapolis, Minnesota, United States

Program in Physical Therapy, University of Minnesota

Minneapolis, Minnesota, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 14586919 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 23340117 (View on PubMed)

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.

Reference Type: RESULT

PMID: 26217209 (View on PubMed)

Other Identifiers

0608M91226-2

Identifier Type: -

Identifier Source: org_study_id