Ignite Creation Date:
2024-05-06 @ 10:25 AM
Last Modification Date:
2024-10-26 @ 12:30 PM
Study NCT ID:
NCT03253731
Status:
WITHDRAWN
Last Update Posted:
2018-11-20
First Post:
2017-08-17
Brief Title:
Interhemispheric Interaction of Parieto-Motor Cortico-Cortical Plasticity
Sponsor:
National Institute of Neurological Disorders and Stroke NINDS
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Interhemispheric Interaction of Parieto-Motor Cortico-Cortical Plasticity in Human Brain
Status:
WITHDRAWN
Status Verified Date:
2018-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Investigator left the NIH
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Background
The two hemispheres of the brain are connected Changes in one hemisphere affect the other through this connection Research has shown that training new skills in one hand improves the same skills for the other hand Researchers want to learn more about how the brain works to transfer the skills to the other hand
Objective
To learn how changes on one side of the brain affect the other side To study the activity of the left and right sides of the brain in healthy adults
Eligibility
Healthy volunteers ages 18-55 years old who are right-handed
Design
Participants will be screened with a medical history and physical exam They will complete a questionnaire about their handedness This may be done on paper or on a computer Participants may have urine pregnancy tests
Participants will have 2 study visits
Participants will have a structural magnetic resonance imaging MRI scan MRI uses a strong magnetic field and radio waves to take pictures of the brain The scanner is a metal cylinder in a strong magnetic field Participants will lie on a table that slides in and out of the cylinder
Participants will have transcranial magnetic stimulation TMS Two wire coils will be placed on the scalp A brief electrical current passes through the coil and creates a magnetic pulse that affects brain activity Participants may be asked to tense certain muscles or do simple tasks during TMS
Participants will have electromyography Small sticky pad electrodes will be attached to the skin on the hands Muscle activity will be recorded during the TMS procedure
The two hemispheres of the brain are connected Changes in one hemisphere affect the other through this connection Research has shown that training new skills in one hand improves the same skills for the other hand Researchers want to learn more about how the brain works to transfer the skills to the other hand
Objective
To learn how changes on one side of the brain affect the other side To study the activity of the left and right sides of the brain in healthy adults
Eligibility
Healthy volunteers ages 18-55 years old who are right-handed
Design
Participants will be screened with a medical history and physical exam They will complete a questionnaire about their handedness This may be done on paper or on a computer Participants may have urine pregnancy tests
Participants will have 2 study visits
Participants will have a structural magnetic resonance imaging MRI scan MRI uses a strong magnetic field and radio waves to take pictures of the brain The scanner is a metal cylinder in a strong magnetic field Participants will lie on a table that slides in and out of the cylinder
Participants will have transcranial magnetic stimulation TMS Two wire coils will be placed on the scalp A brief electrical current passes through the coil and creates a magnetic pulse that affects brain activity Participants may be asked to tense certain muscles or do simple tasks during TMS
Participants will have electromyography Small sticky pad electrodes will be attached to the skin on the hands Muscle activity will be recorded during the TMS procedure
Detailed Description:
Objective
The purpose of this study is to evaluate the effect of long-term potentiation LTP-like cortical plasticity induced by parieto-motor cortico-cortical paired associative stimulation cc-PAS on the contralateral hemisphere and interhemispheric interactions in normal brain using dual-site transcranial magnetic stimulation TMS We will explore the ipsilateral and contralateral effects of cc-PAS over the left primary motor cortex M1 We hypothesize that the motor evoked potential MEP at S50 the motor evoked potential will change after cc-PAS in the left hemisphere which stimulates M1 after PPC effective cc-PAS not only on the right first dorsal interosseous FDI muscle but also the left FDI muscle
In addition we hypothesize that the MEP at S50 will change after cc-PAS in the left hemisphere which stimulates PPC after M1 ineffective cc-PAS on the right FDI muscle but not the left FDI muscle
Study population
We intend to study 15 healthy-volunteers to have 12 who complete the study Subjects will complete up to one screening visit and two study visits involving two intervention
Design
Subjects will come for one screening visit and two outpatient study visits The screening visit and the first study visit can be performed the same day The second study visit will be done approximately 1 week after the first one TMS-induced electromyographic EMG activity of hand muscles will be recorded as MEPs Using single TMS measure on both the left and right M1 we will measure MEPs and input-out I-O curve for the right and left FDI muscle and abductor digiti minimi ADM muscle respectively Using a paired-pulse TMS paradigm interhemispheric inhibition IHI from the left M1 to the right M1 short-interval intracortical inhibition SICI and intracortical facilitation ICF will be measured on the left FDI and ADM muscles Then the subjects will undergo two plasticity induction procedures of the parieto-motor cc-PAS sessions One of those is the hypothesized efficacious cc-PAS session and the other one is the control a hypothesized ineffective cc-PAS session The two sessions will be separated by approximately one week Each session consists of 100 pairs of double stimulation to the left PPC and left M1 MEPs I-O curve on the bilateral M1 IHI from the left M1 to the right M1 SICI and ICF will be remeasured during the 60 min after receiving cc-PAS
Outcome measures
Primary outcome
The primary outcome measure will be MEP amplitude from the bilateral M1 with respect to time before immediately and 30-45 min after intervention after induction of cc-PAS plasticity over the left hemisphere in each session The amplitude of MEPs on each side of M1 will be compared between before and after cc-PAS with respect to time using ANOVA in each session
Secondary outcome
The degree of IHI from the left M1 to the right M1 SICI and ICF with respect to time before immediately and 30-45 min after intervention will be compared by the ANOVA test The degree of IHI and the change of IHI will be correlated with the primary outcome as measured with a correlation analysis
The purpose of this study is to evaluate the effect of long-term potentiation LTP-like cortical plasticity induced by parieto-motor cortico-cortical paired associative stimulation cc-PAS on the contralateral hemisphere and interhemispheric interactions in normal brain using dual-site transcranial magnetic stimulation TMS We will explore the ipsilateral and contralateral effects of cc-PAS over the left primary motor cortex M1 We hypothesize that the motor evoked potential MEP at S50 the motor evoked potential will change after cc-PAS in the left hemisphere which stimulates M1 after PPC effective cc-PAS not only on the right first dorsal interosseous FDI muscle but also the left FDI muscle
In addition we hypothesize that the MEP at S50 will change after cc-PAS in the left hemisphere which stimulates PPC after M1 ineffective cc-PAS on the right FDI muscle but not the left FDI muscle
Study population
We intend to study 15 healthy-volunteers to have 12 who complete the study Subjects will complete up to one screening visit and two study visits involving two intervention
Design
Subjects will come for one screening visit and two outpatient study visits The screening visit and the first study visit can be performed the same day The second study visit will be done approximately 1 week after the first one TMS-induced electromyographic EMG activity of hand muscles will be recorded as MEPs Using single TMS measure on both the left and right M1 we will measure MEPs and input-out I-O curve for the right and left FDI muscle and abductor digiti minimi ADM muscle respectively Using a paired-pulse TMS paradigm interhemispheric inhibition IHI from the left M1 to the right M1 short-interval intracortical inhibition SICI and intracortical facilitation ICF will be measured on the left FDI and ADM muscles Then the subjects will undergo two plasticity induction procedures of the parieto-motor cc-PAS sessions One of those is the hypothesized efficacious cc-PAS session and the other one is the control a hypothesized ineffective cc-PAS session The two sessions will be separated by approximately one week Each session consists of 100 pairs of double stimulation to the left PPC and left M1 MEPs I-O curve on the bilateral M1 IHI from the left M1 to the right M1 SICI and ICF will be remeasured during the 60 min after receiving cc-PAS
Outcome measures
Primary outcome
The primary outcome measure will be MEP amplitude from the bilateral M1 with respect to time before immediately and 30-45 min after intervention after induction of cc-PAS plasticity over the left hemisphere in each session The amplitude of MEPs on each side of M1 will be compared between before and after cc-PAS with respect to time using ANOVA in each session
Secondary outcome
The degree of IHI from the left M1 to the right M1 SICI and ICF with respect to time before immediately and 30-45 min after intervention will be compared by the ANOVA test The degree of IHI and the change of IHI will be correlated with the primary outcome as measured with a correlation analysis
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 |
|---|---|---|---|
| 17-N-0151 | None | None | None |