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NCT Number: NCT01435681

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

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.

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Key information

Conditions

DYT-1 DYT 1 DYT1 Dyskinesias Dystonia Dystonia musculorum deformans type 1 Nervous System Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

10 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

UF Center for Movement Disorders and Neurorestoration

Gainesville, Florida, 32607, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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)

    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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

University of Florida

Other

Collaborators

  • Brain and Spinal Cord Injury Research Trust Fund

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2014
Study completion
2016
First posted
Sep 19, 2011
Registry last updated
Sep 8, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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