Can Short Latency Afferent Inhibition Give us Clues to Better DYT 1 Dystonia Treatments?
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|ClinicalTrials.gov Identifier: NCT01435681|
Recruitment Status : Completed
First Posted : September 19, 2011
Last Update Posted : September 8, 2016
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.
|Condition or disease|
|DYT-1 DYT1 DYT 1 Dystonia|
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 :||Observational|
|Actual Enrollment :||5 participants|
|Observational Model:||Case Control|
|Official Title:||Can Short Latency Afferent Inhibition Give us Clues to Better Dystonia Treatments?|
|Study Start Date :||May 2012|
|Primary Completion Date :||October 2014|
|Study Completion Date :||August 2016|
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.
- 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 ]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 ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01435681
|United States, Florida|
|UF Center for Movement Disorders and Neurorestoration|
|Gainesville, Florida, United States, 32607|
|Principal Investigator:||Aparna Wagle Shukla, M.D.||University of Florida|