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

Dystonia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01435681
• Other study ID #: 405-2011
• Status: Completed
• Phase: N/A
• First received: September 14, 2011
• Last updated: September 7, 2016
• Start date: May 2012
• Est. completion date: August 2016

Study information

• Verified date: September 2016
• Source: University of Florida
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5
• Est. completion date: August 2016
• Est. primary completion date: October 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 10 Years to 80 Years

Eligibility

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.

• Currently treated with medications and enrolled in evaluation process for DBS surgery to confirm candidacy - OR -

• Previous 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

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Dystonia
• Dystonic Disorders
• DYT 1
• DYT-1
• DYT1

Locations

Country	Name	City	State
United States	UF Center for Movement Disorders and Neurorestoration	Gainesville	Florida

Sponsors (2)

Lead Sponsor	Collaborator
University of Florida	Brain and Spinal Cord Injury Research Trust Fund

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Correlation of change in evoked potential amplitudes and clinical measures at 3 and 6+ months	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.	3- and 6+-months post-DBS surgery	No

External Links

•   UF Center for Movement Disorders & Neurorestoration