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

NCT ID: NCT01435681

Last Updated: 2016-09-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

5 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-05-31

Study Completion Date

2016-08-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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DYT-1 DYT1 DYT 1 Dystonia

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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DYT-1 Postive

This group includes those participants who enroll having a genetically confirmed primary generalized dystonia diagnosis.

No interventions assigned to this group

Control

This group includes healthy subjects between the ages of 18 and 80.

No interventions assigned to this group

Eligibility Criteria

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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.


* Cannot have family history or personal history of medication refractory epilepsy
Minimum Eligible Age

10 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Brain and Spinal Cord Injury Research Trust Fund

OTHER

Sponsor Role collaborator

University of Florida

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Aparna Wagle Shukla, M.D.

Role: PRINCIPAL_INVESTIGATOR

University of Florida

Locations

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UF Center for Movement Disorders and Neurorestoration

Gainesville, Florida, United States

Site Status

Countries

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United States

Related Links

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http://movementdisorders.ufhealth.org/

UF Center for Movement Disorders \& Neurorestoration

Other Identifiers

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405-2011

Identifier Type: -

Identifier Source: org_study_id

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