Somatosensory Processing in Focal Hand Dystonia

Focal Hand Dystonia Clinical Trial

Official title:

Tactile Operant Conditioning To Alleviate Focal Hand Dystonia Symptoms

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00579033
• Other study ID #: 05-0959-A
• Secondary ID: 05-0959-A
• Status: Recruiting
• Phase: N/A
• First received: December 17, 2007
• Last updated: December 19, 2007
• Start date: May 2007
• Est. completion date: July 2008

Study information

• Verified date: March 2007
• Source: University Health Network, Toronto
• Contact: Aimee J Nelson, PhD
• Phone: 416-603-5792
• Email: anelson[@]uhnres.utoronto.ca
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 24
• Est. completion date: July 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dystonia
• Dystonic Cramp
• Dystonic Disorders
• Focal Hand Dystonia
• Musician's Dystonia
• Writer's Cramp

Intervention

Other:
• Tactile training + sham rTMS
tactile training for 2.5/hr/day for 15 days - this plus the sham rTMS
• Tactile training + rTMS
tactile training 2.5/hr/day for 15 days plus daily 5Hz rTMS

Locations

Country	Name	City	State
Canada	Toronto Western Hosptial	Toronto	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
University Health Network, Toronto	Dystonia Medical Research Foundation

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dystonia Rating Scale		4 weeks	No
Secondary	Neuroimaging maps of digit representation		4 weeks	No