Can Short Latency Afferent Inhibition Give us Clues to Better DYT 1 Dystonia Treatments?

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01435681
Recruitment Status : Completed
First Posted : September 19, 2011
Last Update Posted : September 8, 2016
Brain and Spinal Cord Injury Research Trust Fund
Information provided by (Responsible Party):
University of Florida

Brief Summary:

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

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 : Observational
Actual Enrollment : 5 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: Can Short Latency Afferent Inhibition Give us Clues to Better Dystonia Treatments?
Study Start Date : May 2012
Actual Primary Completion Date : October 2014
Actual Study Completion Date : August 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dystonia
U.S. FDA Resources

DYT-1 Postive
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.

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   10 Years to 80 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Subjects scheduled to undergo pallidal deep brain stimulation surgery for DYT1 dystonia will be enrolled up to 12 months for this pilot trial. Genetic test results confirming DYT1 gene mutation will be reviewed prior to consenting research subjects. Patients who are diagnosed with DYT1 dystonia and are candidates for DBS surgery will be indentified as candidates for the research study. Additionally, subjects who have already undergone DBS surgery will be identified as candidates.


  • 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


  • 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

Information from the National Library of Medicine

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 identifier (NCT number): NCT01435681

United States, Florida
UF Center for Movement Disorders and Neurorestoration
Gainesville, Florida, United States, 32607
Sponsors and Collaborators
University of Florida
Brain and Spinal Cord Injury Research Trust Fund
Principal Investigator: Aparna Wagle Shukla, M.D. University of Florida

Additional Information:
Responsible Party: University of Florida Identifier: NCT01435681     History of Changes
Other Study ID Numbers: 405-2011
First Posted: September 19, 2011    Key Record Dates
Last Update Posted: September 8, 2016
Last Verified: September 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

Keywords provided by University of Florida:
deep brain stimulation
transcranial magnetic stimulation

Additional relevant MeSH terms:
Dystonic Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Movement Disorders
Central Nervous System Diseases