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

This study is currently recruiting participants.
Verified March 2014 by University of Florida
Sponsor:
Collaborator:
Brain and Spinal Cord Injury Research Trust Fund (BSCIRTF)
Information provided by (Responsible Party):
University of Florida
ClinicalTrials.gov Identifier:
NCT01435681
First received: September 14, 2011
Last updated: March 24, 2014
Last verified: March 2014
  Purpose

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
DYT-1
DYT1
DYT 1
Dystonia

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Can Short Latency Afferent Inhibition Give us Clues to Better Dystonia Treatments?

Resource links provided by NLM:


Further study details as provided by University of Florida:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 18
Study Start Date: May 2012
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
DYT-1 Postive
This group includes those participants who enroll having a genetically confirmed primary generalized dystonia diagnosis.
Control
This group includes healthy subjects between the ages of 18 and 80.

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.

  Eligibility

Ages Eligible for Study:   10 Years to 80 Years
Genders Eligible for Study:   Both
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 within the past 6 months and healthy controls will be identified as candidates.

Criteria

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.
  • Enrolled in evaluation process for DBS surgery.
  • Currently treated with medications and, in the view of the treating neurologist, have not responded well and are therefore deemed a candidate for 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01435681

Contacts
Contact: Amanda Eilers, BA 352-294-5434 amanda.eilers@neurology.ufl.edu
Contact: Simone Roberts, BS 352-273-5566 simone.roberts@neurology.ufl.edu

Locations
United States, Florida
UF Center for Movement Disorders and Neurorestoration Recruiting
Gainesville, Florida, United States, 32607
Contact: Stacy Merritt, MA    352-273-5614    stacy.merritt@neurology.ufl.edu   
Contact: Aparna Wagle Shukla, MD    352-273-5500    aparna.shukla@neurology.ufl.edu   
Sub-Investigator: Kelly D. Foote, M.D.         
Sub-Investigator: Michael S. Okun, M.D.         
Sub-Investigator: Ramon L. Rodriguez, M.D.         
Sub-Investigator: Irene AC Malaty, M.D.         
Sub-Investigator: Nikolaus McFarland, M.D., PhD.         
Sponsors and Collaborators
University of Florida
Brain and Spinal Cord Injury Research Trust Fund (BSCIRTF)
Investigators
Principal Investigator: Aparna Wagle Shukla, M.D. University of Florida
  More Information

Additional Information:
No publications provided

Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT01435681     History of Changes
Other Study ID Numbers: 405-2011
Study First Received: September 14, 2011
Last Updated: March 24, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Florida:
DYT-1
DYT1
DYT 1
dystonia
DBS
deep brain stimulation
TMS
transcranial magnetic stimulation

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

ClinicalTrials.gov processed this record on April 17, 2014