Ignite Creation Date:
2024-05-06 @ 7:15 AM
Last Modification Date:
2024-10-26 @ 11:46 AM
Study NCT ID:
NCT02504905
Status:
COMPLETED
Last Update Posted:
2024-01-11
First Post:
2015-07-21
Brief Title:
Propensity to Develop Plasticity in the Parieto-Motor Networks in Dystonia From the Perspective of Abnormal High-Order Motor Processing
Sponsor:
National Institute of Neurological Disorders and Stroke NINDS
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Propensity to Develop Plasticity in the Parieto-motor Network in Dystonia From the Perspective of Abnormal High-Order Motor Processing
Status:
COMPLETED
Status Verified Date:
2024-09-09
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:
Background
- People with dystonia have muscle contractions they can t control These cause slow repeated motions or abnormal postures People with dystonia have abnormalities in certain parts of the brain Researchers want to study the activity of two different brain areas in people with writer s cramp and cervical dystonia
Objective
- To compare brain activity in people with dystonia to that in healthy people
Eligibility
Right-handed people ages of 18-65 with cervical dystonia or writer s cramp
Healthy volunteers the same ages
Design
Participants will be screened with a physical exam They will answer questions about being right- or left-handed
At study visit 1 participants willTAB
Have a neurological exam
Answer questions about how their disease impacts their daily activities
Have a structural magnetic resonance imaging MRI scan Participants will lie on a table that can slide TABin and out of a metal cylinder This is surrounded by a strong magnetic field
Do 2 simple computer tasks
At study visit 2
Participants will have transcranial magnetic stimulations TMS at 2 places on the head Two wire coils will be held on the scalp A brief electrical current creates a magnetic pulse that affects brain activity Muscles of the face arm or leg might twitch Participants may have to tense certain muscles or do simple tasks during TMS They may be asked to rate any discomfort caused by TMS
Muscle activity in the right hand will be recorded by electrodes stuck to the skin of that hand
- People with dystonia have muscle contractions they can t control These cause slow repeated motions or abnormal postures People with dystonia have abnormalities in certain parts of the brain Researchers want to study the activity of two different brain areas in people with writer s cramp and cervical dystonia
Objective
- To compare brain activity in people with dystonia to that in healthy people
Eligibility
Right-handed people ages of 18-65 with cervical dystonia or writer s cramp
Healthy volunteers the same ages
Design
Participants will be screened with a physical exam They will answer questions about being right- or left-handed
At study visit 1 participants willTAB
Have a neurological exam
Answer questions about how their disease impacts their daily activities
Have a structural magnetic resonance imaging MRI scan Participants will lie on a table that can slide TABin and out of a metal cylinder This is surrounded by a strong magnetic field
Do 2 simple computer tasks
At study visit 2
Participants will have transcranial magnetic stimulations TMS at 2 places on the head Two wire coils will be held on the scalp A brief electrical current creates a magnetic pulse that affects brain activity Muscles of the face arm or leg might twitch Participants may have to tense certain muscles or do simple tasks during TMS They may be asked to rate any discomfort caused by TMS
Muscle activity in the right hand will be recorded by electrodes stuck to the skin of that hand
Detailed Description:
Objective
The purpose of this protocol is to improve understanding of the pathophysiology of dystonia by performing an electrophysiological study using plasticity induction protocols based on dual-site transcranial magnetic stimulation TMS We hypothesize that dystonic patients have enhanced responsiveness to plasticity induction in the parieto-motor network The clinical significance of such an enhanced plasticity will be evaluated by correlating the plasticity measurements with subjects performance on two tasks engaging high-order motor processing and involving the parietal cortex
Study population
This study will explore the parieto-motor network PAR study There will be two independent arms in each study one will compare patients with writer s cramp WC and age-matched healthy volunteers HV and the other one will compare patients with cervical dystonia CD with age-matched HVs The power analysis of thePAR study indicates that we need to enroll 17 patients and 17 healthy volunteers in each arm with an additional 3 added to account for drop-outs Therefore we request a maximum of 20 subjects per patient group and 40 subjects for the control groups
Design
Subjects will come for one screening visit and two outpatient study visits During the first study visit patients will be scored clinically for dystonia They will also undergo a structural magnetic resonance imaging MRI to locate the parietal target during the stimulation session At least 24 hours later during study visit two subjects will receive TMS TMS-induced electromyographic EMG activity of hand muscles will be recorded as motor evoked potentials MEPs Using single TMS shocks we will measure at baseline the input-output I-O curve for the right first dorsal interosseous FDI muscle MEPs Then the subjects will receive a plasticity induction protocol aiming to induce plasticity in the pathway linking the posterior parietal PP cortex and the primary motor cortex M1 To that end transcranial stimulation will be applied repeatedly 100 pairs to the left angular gyrus in the PP cortex and to the left M1 At the end of the intervention the I-O curve will be measured again over the next 50 minutes
Outcome measures
The amplitude of the MEPs in the I-O curves gives information about corticospinal excitability as a function of TMS stimulation The primary outcome measure will be the relative change of the MEP size with respect to time before and 15-20 min after the plasticity intervention The difference in MEP size will be compared between the HV and the patient groups using a T test
The purpose of this protocol is to improve understanding of the pathophysiology of dystonia by performing an electrophysiological study using plasticity induction protocols based on dual-site transcranial magnetic stimulation TMS We hypothesize that dystonic patients have enhanced responsiveness to plasticity induction in the parieto-motor network The clinical significance of such an enhanced plasticity will be evaluated by correlating the plasticity measurements with subjects performance on two tasks engaging high-order motor processing and involving the parietal cortex
Study population
This study will explore the parieto-motor network PAR study There will be two independent arms in each study one will compare patients with writer s cramp WC and age-matched healthy volunteers HV and the other one will compare patients with cervical dystonia CD with age-matched HVs The power analysis of thePAR study indicates that we need to enroll 17 patients and 17 healthy volunteers in each arm with an additional 3 added to account for drop-outs Therefore we request a maximum of 20 subjects per patient group and 40 subjects for the control groups
Design
Subjects will come for one screening visit and two outpatient study visits During the first study visit patients will be scored clinically for dystonia They will also undergo a structural magnetic resonance imaging MRI to locate the parietal target during the stimulation session At least 24 hours later during study visit two subjects will receive TMS TMS-induced electromyographic EMG activity of hand muscles will be recorded as motor evoked potentials MEPs Using single TMS shocks we will measure at baseline the input-output I-O curve for the right first dorsal interosseous FDI muscle MEPs Then the subjects will receive a plasticity induction protocol aiming to induce plasticity in the pathway linking the posterior parietal PP cortex and the primary motor cortex M1 To that end transcranial stimulation will be applied repeatedly 100 pairs to the left angular gyrus in the PP cortex and to the left M1 At the end of the intervention the I-O curve will be measured again over the next 50 minutes
Outcome measures
The amplitude of the MEPs in the I-O curves gives information about corticospinal excitability as a function of TMS stimulation The primary outcome measure will be the relative change of the MEP size with respect to time before and 15-20 min after the plasticity intervention The difference in MEP size will be compared between the HV and the patient groups using a T test
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
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 |
|---|---|---|---|
| 15-N-0167 | None | None | None |