Ignite Creation Date:
2024-05-05 @ 5:13 PM
Last Modification Date:
2024-10-26 @ 9:29 AM
Study NCT ID:
NCT00413842
Status:
COMPLETED
Last Update Posted:
2017-07-02
First Post:
2006-12-19
Brief Title:
Effects of tDCS Over the Cerebellum on Motor Function
Sponsor:
National Institute of Neurological Disorders and Stroke NINDS
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Effects of tDCS Over the Cerebellum on Motor Function
Status:
COMPLETED
Status Verified Date:
2008-08-20
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 evaluate whether applying electrical stimulation on the cerebellum posterior and lower part of the brain can influence brain excitability and hand movement performance
A new technique became available to stimulate the brain transcranial direct current stimulation tDCS which could improve the ability to learn Researchers do not know whether applying tDCS over the cerebellum could also influence motor function and they want to examine changes in brain excitability by using transcranial magnetic stimulation TMS
Patients ages 18 to 40 who are not pregnant may be eligible for this study They will come to NIH for a medical history and completing a questionnaire about memory and attention There will be five experiments each up to 5 hours for about 1 to 5 weeks in which patients perform tasks like pinching a special device between the thumb and index fingers or reaching for target objects on the computer screen Patients will receive mild electrical stimulation over a different part of the head each day Some experiments are done without the electrical current but patients will not know which ones are with or without stimulation There are also short questionnaires about attention fatigue and mood to be completed before during and after each experiment
Patients will be connected to an electromyography EMG machine to measure electrical activity of muscles Electrodes are taped to the skin over one small hand muscle TMS allows electrical pulses to pass through the brain to stimulate it TMS is used at the beginning of each experiment to determine the precise location on the scalp of two target areas cerebellum and motor cortex TMS is a safe procedure Discomfort headache or nausea can occur but all symptoms usually go away promptly During motor learning under tDCS also a safe procedure patients sit in a comfortable chair and the arm and wrist and arm are kept still Sponge electrodes are applied on the chin back of the head neck collarbone lateral part of the head or above the eyebrow A small electrical current is passed between electrodes Patients may feel an itching or tingling sensation under the electrodes or see slight light flashes tDCS is applied for 20 to 30 minutes A magnetic resonance imaging MRI scan which may also be involved uses a strong magnetic field and radio waves to obtain images of body organs and tissues Patients lie on a table in a cylinder and may be asked to lie still for up to 60 minutes at a time
This study will not have a direct benefit for participants However knowledge gained may help researchers identify ways to improve movement in people with a brain injury such as chronic stroke
A new technique became available to stimulate the brain transcranial direct current stimulation tDCS which could improve the ability to learn Researchers do not know whether applying tDCS over the cerebellum could also influence motor function and they want to examine changes in brain excitability by using transcranial magnetic stimulation TMS
Patients ages 18 to 40 who are not pregnant may be eligible for this study They will come to NIH for a medical history and completing a questionnaire about memory and attention There will be five experiments each up to 5 hours for about 1 to 5 weeks in which patients perform tasks like pinching a special device between the thumb and index fingers or reaching for target objects on the computer screen Patients will receive mild electrical stimulation over a different part of the head each day Some experiments are done without the electrical current but patients will not know which ones are with or without stimulation There are also short questionnaires about attention fatigue and mood to be completed before during and after each experiment
Patients will be connected to an electromyography EMG machine to measure electrical activity of muscles Electrodes are taped to the skin over one small hand muscle TMS allows electrical pulses to pass through the brain to stimulate it TMS is used at the beginning of each experiment to determine the precise location on the scalp of two target areas cerebellum and motor cortex TMS is a safe procedure Discomfort headache or nausea can occur but all symptoms usually go away promptly During motor learning under tDCS also a safe procedure patients sit in a comfortable chair and the arm and wrist and arm are kept still Sponge electrodes are applied on the chin back of the head neck collarbone lateral part of the head or above the eyebrow A small electrical current is passed between electrodes Patients may feel an itching or tingling sensation under the electrodes or see slight light flashes tDCS is applied for 20 to 30 minutes A magnetic resonance imaging MRI scan which may also be involved uses a strong magnetic field and radio waves to obtain images of body organs and tissues Patients lie on a table in a cylinder and may be asked to lie still for up to 60 minutes at a time
This study will not have a direct benefit for participants However knowledge gained may help researchers identify ways to improve movement in people with a brain injury such as chronic stroke
Detailed Description:
Objectives
Non-invasive brain stimulation can modulate motor function in healthy volunteers and stroke patients when applied over the primary motor cortex M1 M1 is an evident target for therapeutic interventions given its key role in motor control and learning However given the wide variety of motor dysfunctions following focal neurological injuries such as stroke it is desirable to find out whether alternative neuronal structures could also be responsive to non-invasive brain stimulation for enhancing motor recovery The cerebellum is an attractive target for therapeutic non-invasive brain stimulation since i the cerebellum plays a pivotal role in motor learning of reaching and movement synchronization tasks ii the deep cerebellar nuclei are involved in the regulation of M1 neuronal activity through their excitatory drive to M1 and iii the cerebellum may be adaptively recruited after brain injury
The purpose of this study is to find out if application of non-invasive transcranial DC stimulation tDCS can modulate motor cortical function We hypothesize that tDCS of the cerebellar hemisphere ipsilateral Cerebellum IPSI to the target hand will modulate corticomotor excitability and motor function in healthy volunteers
Study Population
40 healthy volunteers 18-40 years
Design
This proof of principle study will determine if tDCS applied over the cerebellum can modulate focally motor excitability as assessed by TMS and motor performance The stimulation parameters to be studied are polarity anodal cathodal and sham tDCS and intensity 1 mA and 2 mA The focality of stimulation will be addressed by applying tDCS over the neck and over M1 in separate control sessions and by monitoring changes in cerebello-cortical excitability with paired-pulse TMS
The outcome measures will be changes in motor cortical excitability as measured with TMS and in performance of an isometric pinch force task a reaching task and a motor sequence timing task Attention and mood will be assessed to rule out nonspecific arousal effects Paired-pulse TMS will be used to demonstrate modulations in cerebello-cortical connections and to characterize changes in intra-cortical excitability
Non-invasive brain stimulation can modulate motor function in healthy volunteers and stroke patients when applied over the primary motor cortex M1 M1 is an evident target for therapeutic interventions given its key role in motor control and learning However given the wide variety of motor dysfunctions following focal neurological injuries such as stroke it is desirable to find out whether alternative neuronal structures could also be responsive to non-invasive brain stimulation for enhancing motor recovery The cerebellum is an attractive target for therapeutic non-invasive brain stimulation since i the cerebellum plays a pivotal role in motor learning of reaching and movement synchronization tasks ii the deep cerebellar nuclei are involved in the regulation of M1 neuronal activity through their excitatory drive to M1 and iii the cerebellum may be adaptively recruited after brain injury
The purpose of this study is to find out if application of non-invasive transcranial DC stimulation tDCS can modulate motor cortical function We hypothesize that tDCS of the cerebellar hemisphere ipsilateral Cerebellum IPSI to the target hand will modulate corticomotor excitability and motor function in healthy volunteers
Study Population
40 healthy volunteers 18-40 years
Design
This proof of principle study will determine if tDCS applied over the cerebellum can modulate focally motor excitability as assessed by TMS and motor performance The stimulation parameters to be studied are polarity anodal cathodal and sham tDCS and intensity 1 mA and 2 mA The focality of stimulation will be addressed by applying tDCS over the neck and over M1 in separate control sessions and by monitoring changes in cerebello-cortical excitability with paired-pulse TMS
The outcome measures will be changes in motor cortical excitability as measured with TMS and in performance of an isometric pinch force task a reaching task and a motor sequence timing task Attention and mood will be assessed to rule out nonspecific arousal effects Paired-pulse TMS will be used to demonstrate modulations in cerebello-cortical connections and to characterize changes in intra-cortical excitability
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 |
|---|---|---|---|
| 07-N-0049 | None | None | None |