Insights Into Deep Brain Stimulation (DBS) for Cervical Dystonia

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by University of Florida
Sponsor:
Collaborators:
Dystonia Coalition
Information provided by (Responsible Party):
University of Florida
ClinicalTrials.gov Identifier:
NCT01671527
First received: August 20, 2012
Last updated: May 13, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention
Cervical Dystonia
Procedure: Transcranial magnetic stimulation (TMS)

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Pathophysiological Insights Into STN DBS for Primary Cervical Dystonia

Resource links provided by NLM:


Further study details as provided by University of Florida:

Primary Outcome Measures:
  • The body's response to transcranial magnetic stimulation (TMS) [ Time Frame: From 1 day to 10 months, based on eligibility ] [ Designated as safety issue: No ]

    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.



Secondary Outcome Measures:
  • Clinical assessment of dystonia severity [ Time Frame: 10 minutes at each study visit ] [ Designated as safety issue: No ]
    Dystonia will be evaluated at each study visit using: the Toronto Western Cervical Dystonia Rating Scale (TWSTRS); the Visual Analogue Scale (VAS) for assessment of dystonia pain and severity


Estimated Enrollment: 70
Study Start Date: August 2012
Estimated Study Completion Date: July 2015
Estimated Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Cervical Dystonia: DBS Subjects
Subjects who have undergone or plan to undergo DBS surgery for cervical dystonia
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.
Cervical Dystonia: Control Subjects
Subjects who DO NOT plan to undergo DBS surgery for cervical dystonia
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.
Healthy Controls
Healthy control subjects who do not have dystonia.
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.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

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.

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01671527

Contacts
Contact: Amanda Eilers, BA 352-294-5434 amanda.eilers@neurology.ufl.edu
Contact: Stacy Merritt, MA 352-273-5614 stacy.merritt@neurology.ufl.edu

Locations
United States, Florida
University of Florida Recruiting
Gainesville, Florida, United States, 32607
Principal Investigator: Aparna Wagle Shukla, MD         
Sponsors and Collaborators
University of Florida
Dystonia Coalition
Investigators
Principal Investigator: Aparna Wagle Shukla, MD University of Florida
  More Information

Additional Information:
No publications provided

Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT01671527     History of Changes
Other Study ID Numbers: 3142012
Study First Received: August 20, 2012
Last Updated: May 13, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Florida:
Deep Brain Stimulation
DBS
Transcranial Magnetic Stimulation
TMS
Cervical Dystonia
Dystonia
Control
Healthy

Additional relevant MeSH terms:
Dystonia
Dystonic Disorders
Torticollis
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Movement Disorders
Central Nervous System Diseases

ClinicalTrials.gov processed this record on July 23, 2014