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Procedure
Accelerated TMS for Hand Dystonia
N/A
Recruiting
Led By Noreen Bukhari-Parlakturk, MD PhD
Research Sponsored by Duke University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
18yrs and older
Be older than 18 years old
Must not have
History of seizure disorder
Other neurological movement disorders diagnoses including other types of dystonia, Parkinsonism, or essential tremor
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 0 days, 2 weeks and 12 weeks post-tms
Summary
This trial studies the effects of a type of brain stimulation on people with focal hand dystonia to improve behavior and understand brain changes from the treatment.
Who is the study for?
This trial is for adults over 18 with isolated focal hand dystonia, confirmed by a neurologist. Participants must be right-handed, able to give informed consent and literate. Excluded are those with other movement disorders or seizure history, recent drug use or certain treatments like TMS therapy, botulinum toxin injections, specific medications for dystonia symptoms, and recent hand therapy.
What is being tested?
The study tests accelerated transcranial magnetic stimulation (TMS) on patients with focal hand dystonia. It involves four TMS sessions in one day and assesses the impact on brain function and writing behavior immediately after, at two weeks and twelve weeks post-treatment using functional MRI scans.
What are the potential side effects?
While TMS is generally safe when following guidelines, the main potential side effect of concern is seizures; however, risks are minimized through careful participant screening and adherence to safety protocols.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have a history of seizures.
Select...
I have been diagnosed with a movement disorder other than dystonia.
Select...
I am not taking any medications that can lower my seizure threshold.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 0 days, 2 weeks and 12 weeks post-tms
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~0 days, 2 weeks and 12 weeks post-tms
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in behavioral writing measure
Change in brain connectivity in the motor network
Trial Design
3Treatment groups
Active Control
Placebo Group
Group I: TMS to premotor cortexActive Control1 Intervention
Participants receive TMS at premotor cortex
Group II: TMS to primary somatosensory cortexActive Control1 Intervention
Participants received TMS sessions at primary somatosensory cortex
Group III: TMS at low amplitude to primary somatosensory cortexPlacebo Group1 Intervention
Participants receive TMS at a cortical target at smaller amplitude
Find a Location
Who is running the clinical trial?
Duke UniversityLead Sponsor
2,463 Previous Clinical Trials
2,981,840 Total Patients Enrolled
1 Trials studying Isolated Focal Hand Dystonia
12 Patients Enrolled for Isolated Focal Hand Dystonia
American Academy of NeurologyOTHER
11 Previous Clinical Trials
352 Total Patients Enrolled
Noreen Bukhari-Parlakturk, MD PhDPrincipal InvestigatorDuke Health
2 Previous Clinical Trials
62 Total Patients Enrolled
1 Trials studying Isolated Focal Hand Dystonia
12 Patients Enrolled for Isolated Focal Hand Dystonia