- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01435681
Can Short Latency Afferent Inhibition Give us Clues to Better DYT 1 Dystonia Treatments?
Can Short Latency Afferent Inhibition Give us Clues to Better Dystonia Treatments?
This is a research study using transcranial magnetic stimulation (TMS) to investigate interactions between the sensory system and the motor cortex in primary generalized dystonia (DYT1 dystonia) subjects who undergo deep brain stimulation (DBS) surgery.
The sensory system is the body's sense organs - smell, sight, sound, etc. - and the motor cortex is the part of your brain where nerve impulses control voluntary muscle activity.
Study Overview
Detailed Description
The cause of DYT1 dystonia is not clear. DYT1 dystonia symptoms include abnormal posture or repetitive twisting movements affecting one body part; in some patients, the entire body can twist and contort painfully. Magnetic resonance imaging (MRI) studies are normally used to evaluate changes in brain structure in DYT1 dystonia. Transcranial magnetic stimulation (TMS) is a painless, non-invasive method to test how your brain conducts electrical messages to the rest of your body, including your muscles.
If you are a DYT1 dystonia patient, then this study involves up to three visits. The first visit (before DBS surgery) will last about 4 hours and the second and third visits (after DBS surgery) will last about 4 hours as well. These visits will include a complete physical and neurological exam, video recorded dystonia and mood rating scales, followed by electromyography (EMG) and TMS sessions. Subjects who have already undergone DBS surgery may participate in applicable visits based on the length of time since their DBS surgery.
If you are a control subject, this study involves one visit, about 4 hours long. This visit will include TMS and EMG sessions.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Florida
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Gainesville, Florida, United States, 32607
- UF Center for Movement Disorders and Neurorestoration
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
INCLUSION CRITERIA:
- Between the ages of 10 and 80 years. (CONTROL SUBJECTS between 18-80 years)
- Diagnosis and genetic test results confirming diagnosis of DYT1 dystonia.
- Currently treated with medications and enrolled in evaluation process for DBS surgery to confirm candidacy - OR -
- Previous DBS surgery
EXCLUSION CRITERIA:
- Implanted pacemaker, medication pump, vagal stimulator, Transcutaneous electrical nerve stimulation (TENS) unit or ventriculoperitoneal shunt.
- Family or personal history of medication refractory epilepsy.
- Pregnancy: due to the frequent visits over a prolonged period and the lack of Information on the safety of TMS during pregnancy, pregnant women will not be eligible to participate in this study. Women of childbearing potential will be eligible to participate, provided that they are using adequate contraception during TMS treatments.
This study is accepting healthy volunteers, aged 18-80, as control subjects. Control subjects will not undergo DBS surgery.
EXCLUSION CRITERIA (as it applies to healthy control subjects):
- Cannot have family history or personal history of medication refractory epilepsy
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
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DYT-1 Postive
This group includes those participants who enroll having a genetically confirmed primary generalized dystonia diagnosis.
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Control
This group includes healthy subjects between the ages of 18 and 80.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in amplitude, at 3 and 6+ months, of motor evoked potentials (MEPs) with median nerve stimulation (SAI) and simultaneous median nerve and ulnar nerve stimulation (SAIdualstim)
Time Frame: 3 and 6+ months post-DBS surgery
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Surface electromyography (EMG) will be recorded from the first dorsal interosseous muscle to determine the amplitude of potentials evoked in two ways - SAI and SAIdualstim.
For SAI, potentials will be evoked with median nerve stimulation preceding TMS by the N20 latency plus 3 ms.
For SAI dualstim, simultaneous stimulation of median and ulnar nerves will precede TMS by the N20 latency plus 3 ms.
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3 and 6+ months post-DBS surgery
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Correlation of change in evoked potential amplitudes and clinical measures at 3 and 6+ months
Time Frame: 3- and 6+-months post-DBS surgery
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The changes, from baseline to 3 and 6+ months post-operation, in amplitudes recorded during SAI and SAIdualstim testing will will be correlated with the changes in the clinical measures taken at the same timepoints.
The Spearman correlation test will be used for this analysis.
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3- and 6+-months post-DBS surgery
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Aparna Wagle Shukla, M.D., University of Florida
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 405-2011
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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