Ignite Creation Date:
2024-05-06 @ 10:33 AM
Last Modification Date:
2024-10-26 @ 12:31 PM
Study NCT ID:
NCT03288220
Status:
RECRUITING
Last Update Posted:
2024-05-06
First Post:
2017-09-19
Brief Title:
Influence of Brain Oscillation-Dependent TMS on Motor Function
Sponsor:
National Institute of Neurological Disorders and Stroke NINDS
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Influence of Brain Oscillation-Dependent TMS on Motor Function
Status:
RECRUITING
Status Verified Date:
2024-07-31
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
When people have a stroke they often have difficulty moving their arms and hands Transcranial magnetic stimulation TMS can improve how well people with and without stroke can move their arms and hands But the effects of TMS are minor and it doesn t work for everyone Researchers want to study how to time brain stimulation so that the effects are more consistent
Objective
To understand how the brain responds to transcranial magnetic stimulation so that treatments for people with stroke can be improved
Eligibility
Adults ages 18 and older who had a stroke at least 6 months ago
Healthy volunteers ages 50 and older
Design
Participants will have up to 5 visits
At visit 1 participants will be screened with medical history and physical exam Participants with stroke will also have TMS and surface electromyography sEMG
For TMS a brief electrical current will pass through a wire coil on the scalp Participants may hear a click and feel a pull Muscles may twitch Participants may be asked to do simple movements during TMS
For sEMG small electrodes will be attached to the skin and muscle activity will be recorded
At visit 2 participants will have magnetic resonance imaging MRI They will lie on a table that slides into a metal cylinder in a strong magnetic field They will get earplugs for the loud noise
At visit 3 participants will have TMS sEMG and electroencephalography EEG For EEG small electrodes on the scalp will record brainwaves Participants will sit still watch a movie or do TMS
Participants may be asked to have 2 extra visits to redo procedures
When people have a stroke they often have difficulty moving their arms and hands Transcranial magnetic stimulation TMS can improve how well people with and without stroke can move their arms and hands But the effects of TMS are minor and it doesn t work for everyone Researchers want to study how to time brain stimulation so that the effects are more consistent
Objective
To understand how the brain responds to transcranial magnetic stimulation so that treatments for people with stroke can be improved
Eligibility
Adults ages 18 and older who had a stroke at least 6 months ago
Healthy volunteers ages 50 and older
Design
Participants will have up to 5 visits
At visit 1 participants will be screened with medical history and physical exam Participants with stroke will also have TMS and surface electromyography sEMG
For TMS a brief electrical current will pass through a wire coil on the scalp Participants may hear a click and feel a pull Muscles may twitch Participants may be asked to do simple movements during TMS
For sEMG small electrodes will be attached to the skin and muscle activity will be recorded
At visit 2 participants will have magnetic resonance imaging MRI They will lie on a table that slides into a metal cylinder in a strong magnetic field They will get earplugs for the loud noise
At visit 3 participants will have TMS sEMG and electroencephalography EEG For EEG small electrodes on the scalp will record brainwaves Participants will sit still watch a movie or do TMS
Participants may be asked to have 2 extra visits to redo procedures
Detailed Description:
Study Description
We will study if corticospinal excitability intracortical inhibition and intracortical facilitation vary across different sensorimotor alpha and beta electroencephalography EEG waveform oscillation phases in healthy adults and chronic stroke patients In young healthy adults sensorimotor cortical neuronal spiking is highest at sensorimotor alpha oscillation troughs and lowest at sensorimotor alpha oscillation peaks Short interval cortical inhibition SICI is unaffected by alpha phase consistent with alpha phase representing a form of transient pulsed excitation unaffected by gamma-aminobutyric acid GABA-mediated inhibition In contrast to sensorimotor alpha motor evoked potential MEP amplitudes are not maximal at the trough phase of the sensorimotor beta rhythm
Objectives
TMS is a potential adjunct therapy for post-stroke neurorehabilitation So far it has been customarily applied uncoupled from brain oscillatory activity resulting in variability in the biological response to each stimulus small effect sizes and significant inter-individual variability Alpha band oscillatory activity is linked to cortical excitation and inhibition motor function and cognitive processing It is possible that TMS effects could be more consistent when applied to specific phases or phase angles of ongoing brain oscillatory activity For example corticospinal excitability as measured with TMS in healthy humans varies depending on the sensorimotor alpha and beta oscillatory phase during which TMS is delivered There is no information available on intracortical facilitation and inhibition as a function of beta phase angle in healthy humans In Experiments 1 and 3 we have been assessing alpha phase-dependent corticospinal excitability measures In Experiment 2 we will assess beta and secondarily alpha phase-dependent intracortical inhibitory and facilitatory circuits in young and older adults
Endpoints
For experiments 1 and 3 the primary outcome measure is corticospinal excitability For Experiment 2 the primary outcome is SICI Exploratory outcome measures may include MEP amplitude variability SICI short intracortical facilitation SICF and intracortical facilitation ICF and TMS-induced oscillations
We will study if corticospinal excitability intracortical inhibition and intracortical facilitation vary across different sensorimotor alpha and beta electroencephalography EEG waveform oscillation phases in healthy adults and chronic stroke patients In young healthy adults sensorimotor cortical neuronal spiking is highest at sensorimotor alpha oscillation troughs and lowest at sensorimotor alpha oscillation peaks Short interval cortical inhibition SICI is unaffected by alpha phase consistent with alpha phase representing a form of transient pulsed excitation unaffected by gamma-aminobutyric acid GABA-mediated inhibition In contrast to sensorimotor alpha motor evoked potential MEP amplitudes are not maximal at the trough phase of the sensorimotor beta rhythm
Objectives
TMS is a potential adjunct therapy for post-stroke neurorehabilitation So far it has been customarily applied uncoupled from brain oscillatory activity resulting in variability in the biological response to each stimulus small effect sizes and significant inter-individual variability Alpha band oscillatory activity is linked to cortical excitation and inhibition motor function and cognitive processing It is possible that TMS effects could be more consistent when applied to specific phases or phase angles of ongoing brain oscillatory activity For example corticospinal excitability as measured with TMS in healthy humans varies depending on the sensorimotor alpha and beta oscillatory phase during which TMS is delivered There is no information available on intracortical facilitation and inhibition as a function of beta phase angle in healthy humans In Experiments 1 and 3 we have been assessing alpha phase-dependent corticospinal excitability measures In Experiment 2 we will assess beta and secondarily alpha phase-dependent intracortical inhibitory and facilitatory circuits in young and older adults
Endpoints
For experiments 1 and 3 the primary outcome measure is corticospinal excitability For Experiment 2 the primary outcome is SICI Exploratory outcome measures may include MEP amplitude variability SICI short intracortical facilitation SICF and intracortical facilitation ICF and TMS-induced oscillations
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 |
|---|---|---|---|
| 17-N-0168 | None | None | None |