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Focal Hand DystoniaNCT00579033

Somatosensory Processing in Focal Hand Dystonia

A study testing Tactile training + rTMS in people with Focal Hand Dystonia and Musician's Dystonia, run by University Health Network, Toronto at 1 site in Canada.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

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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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Tactile training + rTMS
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
24 participants
Where
1 siteCanada
Study dates
May 2007to Jul 2008
Phase
Interventional

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Aimee J Nelson, PhD contact

416-603-5792

anelson@uhnres.utoronto.ca

Robert Chen, MD contact

416-603-5424

robert.chen@uhn.on.ca

Canada1 site, 1 recruiting
  • Toronto Western Hosptial

    Toronto, Ontario, M5T2S8

    Aimee J Nelson, PhD, 416-603-5792, anelson@uhnres.utoronto.ca

    Carolyn Gunraj, MSc, 416-603-5792, carolyn.gunraj@uhn.on.ca

    Recruiting

Other trials in Canada

About this study

Official title: Tactile Operant Conditioning To Alleviate Focal Hand Dystonia Symptoms

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.

Read more

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.

Being tested
Tactile training + sham rTMS, Tactile training + rTMS
Keywords
somatosensory, cortex, neuroimaging, tactile, cortical plasticity, dystonia
Medical subject headings
Dystonia, Focal, Task-Specific, Dystonic Disorders, Dystonia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Tactile training + sham rTMSOther

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

  • Tactile training + rTMSOther

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

Study groups in NCT00579033
Study groupRoleWhat they receive
1Sham comparatorNot described
Receives: Other: Tactile training + sham rTMS
2Active comparatorNot described
Receives: Other: Tactile training + rTMS

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Dystonia Rating Scale

    Measured: 4 weeks

Secondary outcomes (1)
  1. Neuroimaging maps of digit representation

    Measured: 4 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Dec 2007 (estimated)
  2. Study startMay 2007
  3. Study completionJul 2008 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
24 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00579033
Sponsor's protocol ID
05-0959-A
Other IDs
05-0959-A
Status last verified
Mar 2007
First submitted
17 Dec 2007
Last updated
21 Dec 2007
Results posted
No
Data monitoring committee
No

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