Insights Into Deep Brain Stimulation (DBS) for Cervical Dystonia
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Neurology, Orthopedic, Women's Studies |
| Therapuetic Areas: | Neurology, Orthopedics / Podiatry, Reproductive |
| Healthy: | No |
| Age Range: | 18 - 80 |
| Updated: | 4/23/2016 |
| Start Date: | August 2012 |
| End Date: | June 2016 |
Pathophysiological Insights Into STN DBS for Primary Cervical Dystonia
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.
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.
Subjects will participate in 1-3 visits, based on eligibility, as described below:
Study Visit 1: Baseline
- This visit applies to subjects with cervical dystonia who are planning DBS surgery in
the next 1-4 weeks
- This visit applies to subjects with cervical dystonia who are not planning DBS surgery
- This visit (except #3) applies to healthy control subjects; this is the only visit for
healthy control subjects
1. A neurological examination with special attention to the sensory system will be
performed. The sensory system is the system by which the brain receives and
perceives feelings from different parts of the body.
2. Women of child-bearing potential will be given a urine pregnancy test to evaluate
pregnancy status.
3. DYSTONIA SUBJECTS ONLY: Clinical assessment of dystonia will be performed by
administering several scales and measures, including: the Toronto Western Cervical
Dystonia Rating Scale (TWSTRS), the Short Form (SF-36) scale for quality of life
assessment, Visual Analog Scale (VAS) for assessment of dystonia and pain
severity, the Mini Mental Status Examination (MMSE) for cognitive testing, and the
Beck Depression Inventory (BDI II), for evaluation of mood.
4. We will determine your individual motor evoked potential (MEP) threshold before
beginning the study treatment. Your MEP will be recorded from a muscle located
between the right thumb and index finger on your right hand, and then on your left
hand. MEP threshold refers to the amount of stimulation to the brain that is
required to activate muscle cells enough to appear on an electromyography (EMG),
which records electrical potential in muscle through electrodes placed on the
skin.
5. We will test your sensory system and its interaction with the motor cortex by
using transcranial magnetic Stimulation (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 at 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.
6. We will spend an additional 30 minutes performing a protocol that allows for
testing of plasticity changes in the brain. This protocol is called paired
associative stimulation (PAS). The median nerve in your wrist and the TMS coil
over your head undergo repeated paired stimulation. Such repeated pairing builds
plasticity effect in the motor cortex. MEP, as explained earlier, is recorded
before and after this protocol.
7. Subjects who have provided consent will be videotaped during this visit.
Study Visit 2:
- This visit will be identical to Visit 1 for subjects with cervical dystonia who are not
planning DBS
- This visit, as described below, applies to subjects with cervical dystonia who have had
DBS less than 3 months prior
1. This study visit involves 2 conditions and will be performed approximately 3
months after DBS surgery over a span of up to 3 days. For each condition your DBS
stimulator will be kept either ON or OFF.
2. A physical examination, including the clinical dystonia rating scales and TMS
tests used during Visit 1, will be administered and recorded for both conditions.
3. PAS, as described above for Visit 1, will be performed both ON and OFF stimulation
to test the plasticity effects of DBS surgery.
4. Additionally, women of childbearing potential will be given a urine pregnancy test
to evaluate pregnancy status.
5. Subjects who have provided consent will be videotaped.
Visit 3:
- This visit applies to subjects who have had DBS surgery 6 months or more prior
1. The method and plan will be identical to that used during Visit 2.
Study Visit 1: Baseline
- This visit applies to subjects with cervical dystonia who are planning DBS surgery in
the next 1-4 weeks
- This visit applies to subjects with cervical dystonia who are not planning DBS surgery
- This visit (except #3) applies to healthy control subjects; this is the only visit for
healthy control subjects
1. A neurological examination with special attention to the sensory system will be
performed. The sensory system is the system by which the brain receives and
perceives feelings from different parts of the body.
2. Women of child-bearing potential will be given a urine pregnancy test to evaluate
pregnancy status.
3. DYSTONIA SUBJECTS ONLY: Clinical assessment of dystonia will be performed by
administering several scales and measures, including: the Toronto Western Cervical
Dystonia Rating Scale (TWSTRS), the Short Form (SF-36) scale for quality of life
assessment, Visual Analog Scale (VAS) for assessment of dystonia and pain
severity, the Mini Mental Status Examination (MMSE) for cognitive testing, and the
Beck Depression Inventory (BDI II), for evaluation of mood.
4. We will determine your individual motor evoked potential (MEP) threshold before
beginning the study treatment. Your MEP will be recorded from a muscle located
between the right thumb and index finger on your right hand, and then on your left
hand. MEP threshold refers to the amount of stimulation to the brain that is
required to activate muscle cells enough to appear on an electromyography (EMG),
which records electrical potential in muscle through electrodes placed on the
skin.
5. We will test your sensory system and its interaction with the motor cortex by
using transcranial magnetic Stimulation (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 at 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.
6. We will spend an additional 30 minutes performing a protocol that allows for
testing of plasticity changes in the brain. This protocol is called paired
associative stimulation (PAS). The median nerve in your wrist and the TMS coil
over your head undergo repeated paired stimulation. Such repeated pairing builds
plasticity effect in the motor cortex. MEP, as explained earlier, is recorded
before and after this protocol.
7. Subjects who have provided consent will be videotaped during this visit.
Study Visit 2:
- This visit will be identical to Visit 1 for subjects with cervical dystonia who are not
planning DBS
- This visit, as described below, applies to subjects with cervical dystonia who have had
DBS less than 3 months prior
1. This study visit involves 2 conditions and will be performed approximately 3
months after DBS surgery over a span of up to 3 days. For each condition your DBS
stimulator will be kept either ON or OFF.
2. A physical examination, including the clinical dystonia rating scales and TMS
tests used during Visit 1, will be administered and recorded for both conditions.
3. PAS, as described above for Visit 1, will be performed both ON and OFF stimulation
to test the plasticity effects of DBS surgery.
4. Additionally, women of childbearing potential will be given a urine pregnancy test
to evaluate pregnancy status.
5. Subjects who have provided consent will be videotaped.
Visit 3:
- This visit applies to subjects who have had DBS surgery 6 months or more prior
1. The method and plan will be identical to that used during Visit 2.
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
We found this trial at
1
site
Gainesville, Florida 32610
(352) 392-3261
Principal Investigator: Aparna Wagle Shukla, MD
University of Florida The University of Florida (UF) is a major, public, comprehensive, land-grant, research...
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