Ignite Creation Date:
2024-05-05 @ 4:50 PM
Last Modification Date:
2024-10-26 @ 9:24 AM
Study NCT ID:
NCT00323765
Status:
COMPLETED
Last Update Posted:
2017-07-02
First Post:
2006-05-09
Brief Title:
Plasticity in Cervical Dystonia
Sponsor:
National Institute of Neurological Disorders and Stroke NINDS
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Plasticity in Cervical Dystonia
Status:
COMPLETED
Status Verified Date:
2008-05-20
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:
This study will identify changes that occur in the part of the brain that controls hand movements in patients with cervical neck dystonia Patients with dystonia have muscle spasms that cause abnormal postures while trying to perform a movement In focal dystonia just one part of the body such as the hand neck or face is involved The study will compare findings in healthy volunteers and patients with cervical dystonia to learn more about the condition
Healthy volunteers and patients with cervical dystonia 18 years of age and older may be eligible to participate Candidates are screened with a medical history and physical examination Participants undergo the following tests
Somatosensory evoked potentials Visits 1 and 2
This test examines how sensory information travels from the nerves to the spinal cord and brain An electrode placed on an arm or leg delivers a small electrical stimulus and additional electrodes placed on the scalp neck and over the collarbone record how the impulse from the stimulus travels over the nerve pathways
Transcranial Magnetic Stimulation Visits 2 3 and 4
This procedure maps brain function A wire coil is held on the scalp A brief electrical current passes through the coil creating a magnetic pulse that stimulates the brain The stimulation may cause a twitch in muscles of the face arm or leg and the subject may hear a click and feel a pulling sensation on the skin under the coil
Nerve conduction studies Visits 2 3 and 4
This test measures how fast nerves conduct electrical impulses and the strength of the connection between the nerve and the muscle Nerves are stimulated through small wire electrodes attached to the skin and the response is recorded and analyzed
Surface electromyography Visits 2 3 and 4
Electrodes are placed on the front and back of the neck muscles to measure the electrical activity of the muscles
Healthy volunteers and patients with cervical dystonia 18 years of age and older may be eligible to participate Candidates are screened with a medical history and physical examination Participants undergo the following tests
Somatosensory evoked potentials Visits 1 and 2
This test examines how sensory information travels from the nerves to the spinal cord and brain An electrode placed on an arm or leg delivers a small electrical stimulus and additional electrodes placed on the scalp neck and over the collarbone record how the impulse from the stimulus travels over the nerve pathways
Transcranial Magnetic Stimulation Visits 2 3 and 4
This procedure maps brain function A wire coil is held on the scalp A brief electrical current passes through the coil creating a magnetic pulse that stimulates the brain The stimulation may cause a twitch in muscles of the face arm or leg and the subject may hear a click and feel a pulling sensation on the skin under the coil
Nerve conduction studies Visits 2 3 and 4
This test measures how fast nerves conduct electrical impulses and the strength of the connection between the nerve and the muscle Nerves are stimulated through small wire electrodes attached to the skin and the response is recorded and analyzed
Surface electromyography Visits 2 3 and 4
Electrodes are placed on the front and back of the neck muscles to measure the electrical activity of the muscles
Detailed Description:
Objectives
The main objective of this proposal is to evaluate plasticity in patients with cervical dystonia Neither abnormal Hebbian nor non-Hebbian plasticity has been studied for cervical dystonia
Our specific objectives are to show that
1 In patients with cervical dystonia Hebbian plasticity can be induced by using paired associative stimulation PAS of the dystonic sternocleidomastoid muscle SCM muscle and will be enhanced compared to that of healthy subjects
2 In patients with cervical dystonia non-Hebbian plasticity can be induced by using transcutaneous electrical nerve stimulation TENS of the dystonic SCM muscle and will be enhanced compared to that of healthy subjects
3 In patients with cervical dystonia Hebbian and non-Hebbian plasticity can be induced by dual stimulation DS of the dystonic SCM muscle this effect will be greater than PAS or TENS alone and it will be enhanced compared to that of healthy subjects
Study Population
We will study 22 patients with cervical dystonia and 22 healthy subjects for a total of 44 subjects
Study Design
Subjects will participate in 4 different sessions
Visit 1 clinical screening 1 hour and sensory evoked potential SEP assessment 2 hours total of 3 hours
Visit 2 PAS session of the target muscle and monitoring of cortical excitability before T0 immediately after T1 45 minutes after T2 and 90 minutes after T3 Total of 4 hours
Visit 3 TENS session of the target muscle and monitoring of cortical excitability before T0 immediately after T1 45 minutes after T2 and 90 minutes after T3 Total of 4 hours
Visit 4 DS session of the target and monitoring of cortical excitability before T0 immediately after T1 45 minutes after T2 and 90 minutes after T3 Total of 4 hours
Outcome Measures
The electrophysiological effects of the interventions will be assessed by the size of motor evoked potentials MEP resting and active motor threshold RMT and AMT and a transcranial magnetic stimulation TMS input-output curve The activity of intracortical interneurons mediating long intracortical inhibition LICI will be assessed by paired-pulse TMS The effect of afferent input on intracortical processes long afferent inhibition LAI will be assessed by stimulating the skin overlying the sternocleidomastoid muscle SCM
The main objective of this proposal is to evaluate plasticity in patients with cervical dystonia Neither abnormal Hebbian nor non-Hebbian plasticity has been studied for cervical dystonia
Our specific objectives are to show that
1 In patients with cervical dystonia Hebbian plasticity can be induced by using paired associative stimulation PAS of the dystonic sternocleidomastoid muscle SCM muscle and will be enhanced compared to that of healthy subjects
2 In patients with cervical dystonia non-Hebbian plasticity can be induced by using transcutaneous electrical nerve stimulation TENS of the dystonic SCM muscle and will be enhanced compared to that of healthy subjects
3 In patients with cervical dystonia Hebbian and non-Hebbian plasticity can be induced by dual stimulation DS of the dystonic SCM muscle this effect will be greater than PAS or TENS alone and it will be enhanced compared to that of healthy subjects
Study Population
We will study 22 patients with cervical dystonia and 22 healthy subjects for a total of 44 subjects
Study Design
Subjects will participate in 4 different sessions
Visit 1 clinical screening 1 hour and sensory evoked potential SEP assessment 2 hours total of 3 hours
Visit 2 PAS session of the target muscle and monitoring of cortical excitability before T0 immediately after T1 45 minutes after T2 and 90 minutes after T3 Total of 4 hours
Visit 3 TENS session of the target muscle and monitoring of cortical excitability before T0 immediately after T1 45 minutes after T2 and 90 minutes after T3 Total of 4 hours
Visit 4 DS session of the target and monitoring of cortical excitability before T0 immediately after T1 45 minutes after T2 and 90 minutes after T3 Total of 4 hours
Outcome Measures
The electrophysiological effects of the interventions will be assessed by the size of motor evoked potentials MEP resting and active motor threshold RMT and AMT and a transcranial magnetic stimulation TMS input-output curve The activity of intracortical interneurons mediating long intracortical inhibition LICI will be assessed by paired-pulse TMS The effect of afferent input on intracortical processes long afferent inhibition LAI will be assessed by stimulating the skin overlying the sternocleidomastoid muscle SCM
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 |
|---|---|---|---|
| 06-N-0157 | None | None | None |