Insights Into Deep Brain Stimulation (DBS) for Cervical Dystonia
Pathophysiological Insights Into STN DBS for Primary Cervical Dystonia
2 other identifiers
observational
29
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Aug 2012
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2012
CompletedFirst Submitted
Initial submission to the registry
August 20, 2012
CompletedFirst Posted
Study publicly available on registry
August 23, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2016
CompletedJune 13, 2016
June 1, 2016
3.6 years
August 20, 2012
June 9, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The body's response to transcranial magnetic stimulation (TMS)
The purpose of this research study is to determine the physical brain changes in people with cervical dystonia after deep brain stimulation (DBS) surgery. We will do this by measuring your body's response to transcranial magnetic stimulation (TMS) before and/or after DBS surgery, unless you are a control subject. If you are a dystonia control subject (not planning DBS), we will measure your body's response to TMS on two occasions. If you are healthy control subject, we will measure your body's response to TMS on one occasion. These tests should help us learn whether the electrical changes in the brain have any relation to the physical benefits some patients with primary cervical dystonia receive from DBS surgery.
From 1 day to 10 months, based on eligibility
Secondary Outcomes (1)
Clinical assessment of dystonia severity
10 minutes at each study visit
Study Arms (3)
Cervical Dystonia: DBS Subjects
Subjects who have undergone or plan to undergo DBS surgery for cervical dystonia
Cervical Dystonia: Control Subjects
Subjects who DO NOT plan to undergo DBS surgery for cervical dystonia
Healthy Controls
Healthy control subjects who do not have dystonia.
Interventions
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.
Eligibility Criteria
Subjects will be recruited from the University of Florida Center for Movement Disorders \& Neurorestoration out-patient population, patient care meetings, the UFMDC research database, and during the course of normal clinical care. Additionally, we plan to enroll subjects from other DBS centers. Patients who are diagnosed with primary (or predominantly primary) cervical dystonia and are candidates for DBS surgery, or who have already had DBS surgery, will be identified as candidates for this research study. Control subjects will be recruited via advertising flyers in the local community.
You may qualify if:
- Between the ages of 18-80 years
- 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)
You may not qualify if:
- Implanted pacemaker, medication pump, vagal stimulator, TENS unit or ventriculoperitoneal shunt
- Family or personal history of medication refractory epilepsy
- Pregnancy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Floridalead
- National Institutes of Health (NIH)collaborator
- Dystonia Coalitioncollaborator
Study Sites (1)
University of Florida
Gainesville, Florida, 32607, United States
Related Publications (1)
Wagle Shukla A, Ostrem JL, Vaillancourt DE, Chen R, Foote KD, Okun MS. Physiological effects of subthalamic nucleus deep brain stimulation surgery in cervical dystonia. J Neurol Neurosurg Psychiatry. 2018 Dec;89(12):1296-1300. doi: 10.1136/jnnp-2017-317098. Epub 2018 Jan 11.
PMID: 29326293DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Aparna Wagle Shukla, MD
University of Florida
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 20, 2012
First Posted
August 23, 2012
Study Start
August 1, 2012
Primary Completion
March 1, 2016
Study Completion
June 1, 2016
Last Updated
June 13, 2016
Record last verified: 2016-06