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Cervical Dystonia | Insights Into Deep Brain Stimulation (DBS) for Cervical Dystonia

Cervical Dystonia research study

What is the primary objective of this study?

The purpose of this research study is to determine the physical brain changes in people with cervical dystonia after deep brain stimulation (DBS) surgery and as compared to healthy controls. We will do this by measuring your body's response to transcranial magnetic stimulation (TMS) before and/or after DBS surgery. TMS is a non-invasive procedure during which you sit in a chair that looks like one you would find at the dentist's office. A nerve stimulator is placed on the wrist of the right hand to stimulate the median nerve; the intensity of the nerve stimulator is gradually increased until the right thumb begins to twitch. A magnetic coil is placed on the scalp on one side of the head, overlying the brain's motor cortex, to stimulate the brain's output to the muscles in the opposite hand. If you are a control subject, and therefore will not/have not have DBS surgery, we will measure the body's response to TMS for comparison purposes. We expect that the electrical differences in the brain may be related to the physical benefits some patients with primary cervical dystonia receive from DBS surgery.

Who is eligible to participate?

Inclusion criteria FOR ALL: - Between the ages of 18-80 years Inclusion criteria FOR CERVICAL DYSTONIA SUBJECTS ONLY: - Diagnosis confirming primary (or predominantly primary) cervical dystonia - Currently treated with medications and (in view of the treating neurologist) has not responded well and is deemed a candidate for DBS surgery; enrolled in the evaluation process for DBS surgery, or - DBS surgery within the last 3 months, or - DBS surgery 6 months or more prior, or - Ineligible or not planning to undergo DBS surgery (dystonia control cohort only) Exclusion Criteria FOR ALL: - Implanted pacemaker, medication pump, vagal stimulator, TENS unit or ventriculoperitoneal shunt - Family or personal history of medication refractory epilepsy - Pregnancy

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Cervical Dystonia

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Procedure:Transcranial magnetic stimulation (TMS)We will test the sensory system and its interaction with the motor cortex by using TMS. For these tests, you will sit in a chair that looks like one you would find at the dentist's office. A nerve stimulator will be placed on the wrist of your right hand to stimulate the median and ulnar nerves. The intensity of the nerve stimulator will be gradually increased until the right thumb begins to twitch. A magnetic coil will be placed on the scalp on the left side of your head, overlying the brain's motor cortex, to stimulate the brain's output to the muscles in the opposite hand. This procedure will be repeated using the left wrist and the right side of your head.

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

Cervical Dystonia: DBS SubjectsSubjects who have undergone or plan to undergo DBS surgery for cervical dystonia

Cervical Dystonia: Control SubjectsSubjects who DO NOT plan to undergo DBS surgery for cervical dystonia

Healthy ControlsHealthy control subjects who do not have dystonia.

Study Status

Completed

Start Date: August 2012

Completed Date: June 2016

Phase:

Type: Observational

Design:

Primary Outcome: The body's response to transcranial magnetic stimulation (TMS)

Secondary Outcome: Clinical assessment of dystonia severity

Study sponsors, principal investigator, and references

Principal Investigator: Aparna Wagle Shukla, MD

Lead Sponsor: University of Florida

Collaborator: National Institutes of Health (NIH)

More information:https://clinicaltrials.gov/show/NCT01671527

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