Somatosensory Processing in Focal Hand Dystonia
Primary Purpose
Focal Hand Dystonia, Musician's Dystonia, Writer's Cramp
Status
Unknown status
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Tactile training + sham rTMS
Tactile training + rTMS
Sponsored by
About this trial
This is an interventional treatment trial for Focal Hand Dystonia focused on measuring somatosensory, cortex, neuroimaging, tactile, cortical plasticity, dystonia
Eligibility 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
Sites / Locations
- Toronto Western HosptialRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Sham Comparator
Active Comparator
Arm Label
1
2
Arm Description
Outcomes
Primary Outcome Measures
Dystonia Rating Scale
Secondary Outcome Measures
Neuroimaging maps of digit representation
Full Information
NCT ID
NCT00579033
First Posted
December 17, 2007
Last Updated
December 19, 2007
Sponsor
University Health Network, Toronto
Collaborators
Dystonia Medical Research Foundation
1. Study Identification
Unique Protocol Identification Number
NCT00579033
Brief Title
Somatosensory Processing in Focal Hand Dystonia
Official Title
Tactile Operant Conditioning To Alleviate Focal Hand Dystonia Symptoms
Study Type
Interventional
2. Study Status
Record Verification Date
March 2007
Overall Recruitment Status
Unknown status
Study Start Date
May 2007 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
July 2008 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
University Health Network, Toronto
Collaborators
Dystonia Medical Research Foundation
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Focal Hand Dystonia, Musician's Dystonia, Writer's Cramp, Dystonic Cramp
Keywords
somatosensory, cortex, neuroimaging, tactile, cortical plasticity, dystonia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
24 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Sham Comparator
Arm Title
2
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
Tactile training + sham rTMS
Intervention Description
tactile training for 2.5/hr/day for 15 days - this plus the sham rTMS
Intervention Type
Other
Intervention Name(s)
Tactile training + rTMS
Intervention Description
tactile training 2.5/hr/day for 15 days plus daily 5Hz rTMS
Primary Outcome Measure Information:
Title
Dystonia Rating Scale
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Neuroimaging maps of digit representation
Time Frame
4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Aimee J Nelson, PhD
Phone
416-603-5792
Email
anelson@uhnres.utoronto.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Robert Chen, MD
Phone
416-603-5424
Email
robert.chen@uhn.on.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aimee J Nelson, PhD
Organizational Affiliation
Toronto Western Research Institute, University of Waterloo
Official's Role
Principal Investigator
Facility Information:
Facility Name
Toronto Western Hosptial
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5T2S8
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Aimee J Nelson, PhD
Phone
416-603-5792
Email
anelson@uhnres.utoronto.ca
First Name & Middle Initial & Last Name & Degree
Carolyn Gunraj, MSc
Phone
416-603-5792
Email
carolyn.gunraj@uhn.on.ca
First Name & Middle Initial & Last Name & Degree
Aimee J Nelson, PhD
First Name & Middle Initial & Last Name & Degree
Chen Robert, MSc, MBB CHir
12. IPD Sharing Statement
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Somatosensory Processing in Focal Hand Dystonia
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