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

NCT01435681 | Completed DMC

• 1 other identifier: 405-2011
• Study Type: observational
• Target: 5
• Locations: 1 country
• Sites: 1

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.

Conditions

DYT1; DYT 1; Dystonia

Keywords

DYT-1; DYT1; DYT 1; dystonia; DBS; deep brain stimulation; TMS; transcranial magnetic stimulation

Outcome Measures

Primary Outcomes (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)

  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.

  3 and 6+ months post-DBS surgery

Secondary Outcomes (1)

• Correlation of change in evoked potential amplitudes and clinical measures at 3 and 6+ months

  3- and 6+-months post-DBS surgery

Study Arms (2)

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.

Eligibility Criteria

• Age: 10 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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.
• Cannot have family history or personal history of medication refractory epilepsy

Sponsors & Collaborators

• University of Florida: lead
• Brain and Spinal Cord Injury Research Trust Fund: collaborator

Study Sites (1)

UF Center for Movement Disorders and Neurorestoration

Gainesville, Florida, 32607, United States

Location

Related Links

• UF Center for Movement Disorders \& Neurorestoration

MeSH Terms

Conditions

Dystonia musculorum deformans type 1; Dystonia

Condition Hierarchy (Ancestors)

Dyskinesias; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Aparna Wagle Shukla, M.D.

  University of Florida

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 14, 2011
• First Posted: September 19, 2011
• Study Start: May 1, 2012
• Primary Completion: October 1, 2014
• Study Completion: August 1, 2016
• Last Updated: September 8, 2016

Record last verified: 2016-09

Data Sharing

• IPD Sharing: Will share

Locations

US (1)