Ignite Creation Date:
2024-05-06 @ 12:51 AM
Last Modification Date:
2024-10-26 @ 10:55 AM
Study NCT ID:
NCT01671527
Status:
COMPLETED
Last Update Posted:
2016-06-13
First Post:
2012-08-20
Brief Title:
Insights Into Deep Brain Stimulation DBS for Cervical Dystonia
Sponsor:
University of Florida
Organization:
University of Florida
Study Overview
Official Title:
Pathophysiological Insights Into STN DBS for Primary Cervical Dystonia
Status:
COMPLETED
Status Verified Date:
2016-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 bodys response to transcranial magnetic stimulation TMS before andor 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 dentists 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 brains motor cortex to stimulate the brains output to the muscles in the opposite hand
If you are a control subject and therefore will nothave not have DBS surgery we will measure the bodys 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
TMS is a non-invasive procedure during which you sit in a chair that looks like one you would find at the dentists 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 brains motor cortex to stimulate the brains output to the muscles in the opposite hand
If you are a control subject and therefore will nothave not have DBS surgery we will measure the bodys 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
Detailed Description:
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 dentists 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 brains motor cortex to stimulate the brains 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 dentists 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 brains motor cortex to stimulate the brains 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| KL2TR000065 | NIH | None | httpsreporternihgovquickSearchKL2TR000065 |