NCT00579033

Brief Summary

Patients with focal dystonia experience uncontrollable movements of the hand during certain types of skilled movements. Though the origin of the disorder is not fully understood, it is thought that brain areas involved in moving the hands and receiving touch information from the hands, are involved. For example, patients with dystonia affecting the hand show changes in their ability to perceive touch - this is something that typically escapes the patients own awareness. Further, the area of the brain receiving touch information has a disrupted representation of the finger skin surfaces. The goal of our research is to improve dystonia symptoms in patients with hand dystonia. We will attempt to achieve this goal by implementing an intensive training treatment that requires patients to attend to, and use touch information applied to specific fingertips. Previous work has attempted to alter touch perception using sensory training and improvements in motor control (hand writing) of dystonia patients were observed. For example, learning to read Braille improves tactile perception and handwriting in focal hand dystonia. A different approach to treat focal hand dystonia involves a technique called repetitive transcranial magnetic stimulation (rTMS), and this can also temporarily improve hand writing in dystonia patients. The proposed research will attempt to alter touch processing using touch training alone, or in combination with rTMS. Rather than train using Braille reading, the sensory training will be applied using a systematic, experimenter controlled stimulus set that focuses on touch stimuli applied to individual digits. Importantly patients will have to associate certain types of touch information with rewards and other touch input with the lack of a reward. The study will first involve measuring the location and representation of the touch in the brain using multiple brain mapping tools. These tools include functional magnetic resonance imaging and magnetoencephalography; when both tools are used a very accurate picture of finger representation can be obtained, and we also know what brain areas respond to touch stimuli. Dystonia symptoms and touch perception will also be assessed. Next, patients will participate in a training intervention that involves 15 days(2.5 hr/day) of touch training applied to the fingertips of the dystonia affected hand. Patients will identify the touch targets amongst distractors and receive on-line performance feedback. The goal of the training is to provide the cortex with regular boundaries of fingers and in this way, attempt to re-shape the sensory cortex to accept these boundaries. Another group of patients will receive rTMS. The goal of the rTMS is to create an environment in sensory cortex that is open or 'ready' to accept changes induced by tactile stimulation. The rTMS will be immediately followed by the tactile training. A third group of patients will receive a placebo version of rTMS followed by tactile training. The latter group will allow us to understand if rTMS has a definite effect on the physiology of the patient. Following the 15-day training, we will assess the brains representation of fingertips, changes in dystonia symptoms and changes in the perception of touch stimuli. This research will advance the treatment of focal hand dystonia and assist the design of precise remediation training tailored to the dystonia patient.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2007

Geographic Reach
1 country

1 active site

Status
unknown

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

May 1, 2007

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

December 17, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 21, 2007

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2008

Completed
Last Updated

December 21, 2007

Status Verified

March 1, 2007

First QC Date

December 17, 2007

Last Update Submit

December 19, 2007

Conditions

Keywords

somatosensorycortexneuroimagingtactilecortical plasticitydystonia

Outcome Measures

Primary Outcomes (1)

  • Dystonia Rating Scale

    4 weeks

Secondary Outcomes (1)

  • Neuroimaging maps of digit representation

    4 weeks

Study Arms (2)

1

SHAM COMPARATOR
Other: Tactile training + sham rTMS

2

ACTIVE COMPARATOR
Other: Tactile training + rTMS

Interventions

tactile training for 2.5/hr/day for 15 days - this plus the sham rTMS

1

tactile training 2.5/hr/day for 15 days plus daily 5Hz rTMS

2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of focal hand dystonia including any but not limited to the following:
  • Writer's cramp,
  • Musician's cramp,
  • Dystonic cramp.

You may not qualify if:

  • Other neurological conditions
  • Epilepsy
  • Carpal tunnel or disorders of peripheral nerves
  • Psychiatric illness

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Toronto Western Hosptial

Toronto, Ontario, M5T2S8, Canada

RECRUITING

MeSH Terms

Conditions

Dystonia, Focal, Task-SpecificDystonic DisordersDystonia

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Movement DisordersCentral Nervous System DiseasesNervous System DiseasesDyskinesiasNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Magnetic Field TherapyTherapeutics

Study Officials

  • Aimee J Nelson, PhD

    Toronto Western Research Institute, University of Waterloo

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Aimee J Nelson, PhD

CONTACT

Robert Chen, MD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 17, 2007

First Posted

December 21, 2007

Study Start

May 1, 2007

Study Completion

July 1, 2008

Last Updated

December 21, 2007

Record last verified: 2007-03

Locations