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.
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
- Conditions the study is for
- Focal Hand Dystonia, Musician's Dystonia, Writer's Cramp
- 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
- Are there results?
- None posted in the registry
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.
Canada1 site, 1 recruiting
- 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
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 group | Role | What they receive |
|---|---|---|
| 1 | Sham comparator | Not described Receives: Other: Tactile training + sham rTMS |
| 2 | Active comparator | Not described Receives: Other: Tactile training + rTMS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dystonia Rating Scale
Measured: 4 weeks
Secondary outcomes (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.
- First posted21 Dec 2007 (estimated)
- Study startMay 2007
- Study completionJul 2008 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Focal Hand DystoniaStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- Dystonia Medical Research Foundation
- Investigators
- Aimee J Nelson, PhD, Principal investigator, Toronto Western Research Institute, University of Waterloo
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
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tactile Operant Conditioning To Alleviate Focal Hand Dystonia Symptoms
- ClinicalTrials.gov ID
- NCT00579033
- Acronym / sponsor ID
- 05-0959-A
- Keywords
- somatosensory, cortex, neuroimaging, tactile, cortical plasticity, dystonia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Collaborators
- Dystonia Medical Research Foundation
- Study start
- May 2007
- Study completion
- Jul 2008 (estimated)
- First posted
- 21 Dec 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Sham comparator | Other: Tactile training + sham rTMS |
| 2 | Active comparator | Other: Tactile training + rTMS |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Diagnosis of focal hand dystonia including any but not limited to the following:
Key exclusion criteria (4 listed)
- Other neurological conditions
- Epilepsy
- Carpal tunnel or disorders of peripheral nerves
- Psychiatric illness
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tactile training + sham rTMStactile training for 2.5/hr/day for 15 days - this plus the sham rTMS | Other | 1 |
| Tactile training + rTMStactile training 2.5/hr/day for 15 days plus daily 5Hz rTMS | Other | 2 |
Primary outcome
Dystonia Rating Scale
Time frame: 4 weeks
1 secondary outcome
Neuroimaging maps of digit representation
Time frame: 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2007.
Related trials for Focal Hand Dystonia
Active, not recruitingPhase 1/2
Deep Brain Stimulation Surgery for Focal Hand Dystonia
Dystonia, Focal Dystonia
Not yet recruiting
VTS Sensorimotor Neuromodulation in WC
Writer's Cramp, Dystonias
Active, not recruiting
Accelerated TMS for Focal Hand Dystonia
Isolated Focal Hand Dystonia
RecruitingPhase 3
IncobotulinumtoxinA (Xeomin) to Treat Focal Hand Dystonia
Focal Hand Dystonia
Recruiting
MRgFUS Pallidotomy for the Treatment of Task Specific Focal Hand Dystonia (TSFD)
Task-Specific Focal Dystonia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aimee J Nelson, PhD principal investigator
Toronto Western Research Institute, University of Waterloo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Dec 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Aimee J Nelson, PhD (416-603-5792, anelson@uhnres.utoronto.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dystonia Rating Scale (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Dec 2007.