Somatosensory Processing in Focal Hand Dystonia

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2007 by University Health Network, Toronto.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Dystonia Medical Research Foundation
Information provided by:
University Health Network, Toronto
ClinicalTrials.gov Identifier:
NCT00579033
First received: December 17, 2007
Last updated: December 19, 2007
Last verified: March 2007
  Purpose

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.


Condition Intervention
Focal Hand Dystonia
Musician's Dystonia
Writer's Cramp
Dystonic Cramp
Other: Tactile training + sham rTMS
Other: Tactile training + rTMS

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Tactile Operant Conditioning To Alleviate Focal Hand Dystonia Symptoms

Resource links provided by NLM:


Further study details as provided by University Health Network, Toronto:

Primary Outcome Measures:
  • Dystonia Rating Scale [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Neuroimaging maps of digit representation [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 24
Study Start Date: May 2007
Estimated Study Completion Date: July 2008
Arms Assigned Interventions
Sham Comparator: 1 Other: Tactile training + sham rTMS
tactile training for 2.5/hr/day for 15 days - this plus the sham rTMS
Active Comparator: 2 Other: Tactile training + rTMS
tactile training 2.5/hr/day for 15 days plus daily 5Hz rTMS

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of focal hand dystonia including any but not limited to the following:

    • Writer's cramp,
    • Musician's cramp,
    • Dystonic cramp.

Exclusion Criteria:

  • Other neurological conditions
  • Epilepsy
  • Carpal tunnel or disorders of peripheral nerves
  • Psychiatric illness
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00579033

Contacts
Contact: Aimee J Nelson, PhD 416-603-5792 anelson@uhnres.utoronto.ca
Contact: Robert Chen, MD 416-603-5424 robert.chen@uhn.on.ca

Locations
Canada, Ontario
Toronto Western Hosptial Recruiting
Toronto, Ontario, Canada, M5T2S8
Contact: Aimee J Nelson, PhD    416-603-5792    anelson@uhnres.utoronto.ca   
Contact: Carolyn Gunraj, MSc    416-603-5792    carolyn.gunraj@uhn.on.ca   
Principal Investigator: Aimee J Nelson, PhD         
Principal Investigator: Chen Robert, MSc, MBB CHir         
Sponsors and Collaborators
University Health Network, Toronto
Dystonia Medical Research Foundation
Investigators
Principal Investigator: Aimee J Nelson, PhD Toronto Western Research Institute, University of Waterloo
  More Information

No publications provided

Responsible Party: Aimee Nelson, Assistant Professor, Toronto Western Research Institute, University of Waterloo
ClinicalTrials.gov Identifier: NCT00579033     History of Changes
Other Study ID Numbers: 05-0959-A, 05-0959-A
Study First Received: December 17, 2007
Last Updated: December 19, 2007
Health Authority: Canada: Health Canada

Keywords provided by University Health Network, Toronto:
somatosensory
cortex
neuroimaging
tactile
cortical plasticity
dystonia

Additional relevant MeSH terms:
Dystonia
Dystonic Disorders
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Movement Disorders
Central Nervous System Diseases

ClinicalTrials.gov processed this record on September 16, 2014