Can Short Latency Afferent Inhibition Give us Clues to Better DYT 1 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 Design:||Observational Model: Case Control
Time Perspective: Prospective
|Official Title:||Can Short Latency Afferent Inhibition Give us Clues to Better Dystonia Treatments?|
- 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 ] [ Designated as safety issue: No ]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.
- Correlation of change in evoked potential amplitudes and clinical measures at 3 and 6+ months [ Time Frame: 3- and 6+-months post-DBS surgery ] [ Designated as safety issue: No ]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.
|Study Start Date:||May 2012|
|Estimated Study Completion Date:||December 2015|
|Estimated Primary Completion Date:||December 2015 (Final data collection date for primary outcome measure)|
This group includes those participants who enroll having a genetically confirmed primary generalized dystonia diagnosis.
This group includes healthy subjects between the ages of 18 and 80.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01435681
|Contact: Amanda Eilers, BAfirstname.lastname@example.org|
|Contact: Julie Segura, B.A.||352-273-5566||Julie.Segura@neurology.ufl.edu|
|United States, Florida|
|UF Center for Movement Disorders and Neurorestoration||Recruiting|
|Gainesville, Florida, United States, 32607|
|Contact: Julie Segura, B.A. 352-273-5566 Julie.Segura@neurology.ufl.edu|
|Contact: Aparna Wagle Shukla, MD 352-273-5500 email@example.com|
|Sub-Investigator: Kelly D. Foote, M.D.|
|Sub-Investigator: Michael S. Okun, M.D.|
|Sub-Investigator: Irene AC Malaty, M.D.|
|Sub-Investigator: Nikolaus McFarland, M.D., PhD.|
|Principal Investigator:||Aparna Wagle Shukla, M.D.||University of Florida|