HealthyNCT00413842
Effects of tDCS Over the Cerebellum on Motor Function
An observational study of Healthy, run by National Institute of Neurological Disorders and Stroke (NINDS) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Healthy
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Dec 2006to 20 Aug 2008
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- age between 18-40 years
- able to perform tasks required by the study
- willing and able to give consent
Who cannot join
- unable to perform the tasks required by the study
- history of severe alcohol or drug abuse, psychiatric illness like severe depression, or severe language disturbances, particularly of receptive nature or with serious cognitive deficits (defined as equivalent to a mini-mental state exam score [MMSE] of 23 or less), or degenerative brain processes such as Alzheimer's disease
- severe uncontrolled medical problems (e.g., cardiovascular disease, severe rheumatoid arthritis, active joint deformity of arthritic origin, active cancer or renal disease, any kind of end-stage pulmonary or cardiovascular disease, or a deteriorated condition due to age, uncontrolled epilepsy or others), more than moderate to severe microangiopathy, polyneuropathy, diabetes mellitus, or ischemic peripheral disease
- problems with movement of the hands
- receiving drugs acting primarily on the central nervous system, which lower the seizure threshold, such as antipsychotic drugs (chlorpromazine, clozapine) or tricyclic antidepressants (for the TMS component only)
- pregnant (for the MRI component only)
- medical or technical contraindications to MRI procedures or devices producing artifacts that impair MRI signal (e.g., pacemakers, implanted medication pumps, cochlear devices, neural stimulators, metal in the cranium, surgical clips, and other metal/magnetic implants, claustrophobia)
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892
About this study
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).
Read more
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.
Read the 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.
- Conditions
- Healthy
- Keywords
- Transcranial Direct Current Stimulation (tDCS), Plasticity, Primary Motor Cortex, Cerebellum, Transcranial Magnetic Stimulation (TMS), Healthy Volunteer, HV
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2006 (estimated)
- Study start14 Dec 2006
- Study completion20 Aug 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by National Institute of Neurological Disorders and Stroke (NINDS)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Enrolment
- 40 participants
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00413842
- Sponsor's protocol ID
- 070049
- Other IDs
- 07-N-0049
- Status last verified
- 20 Aug 2008
- First submitted
- 19 Dec 2006
- Last updated
- 2 Jul 2017
- Results posted
- No
Publications
Fregni F, Boggio PS, Nitsche M, Bermpohl F, Antal A, Feredoes E, Marcolin MA, Rigonatti SP, Silva MT, Paulus W, Pascual-Leone A. Anodal transcranial direct current stimulation of prefrontal cortex enhances working memory. Exp Brain Res. 2005 Sep;166(1):23-30. doi: 10.1007/s00221-005-2334-6. Epub 2005 Jul 6.
PubMed 15999258Antal A, Nitsche MA, Kincses TZ, Kruse W, Hoffmann KP, Paulus W. Facilitation of visuo-motor learning by transcranial direct current stimulation of the motor and extrastriate visual areas in humans. Eur J Neurosci. 2004 May;19(10):2888-92. doi: 10.1111/j.1460-9568.2004.03367.x.
PubMed 15147322Khedr EM, Ahmed MA, Fathy N, Rothwell JC. Therapeutic trial of repetitive transcranial magnetic stimulation after acute ischemic stroke. Neurology. 2005 Aug 9;65(3):466-8. doi: 10.1212/01.wnl.0000173067.84247.36.
PubMed 16087918
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of tDCS Over the Cerebellum on Motor Function
- ClinicalTrials.gov ID
- NCT00413842
- Acronym / sponsor ID
- 070049
- Conditions
- Healthy
- Keywords
- Transcranial Direct Current Stimulation (tDCS), Plasticity, Primary Motor Cortex, Cerebellum, Transcranial Magnetic Stimulation (TMS), Healthy Volunteer, HV
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants
- Lead sponsor
- National Institute of Neurological Disorders and Stroke (NINDS)US National Institutes of Health
- Study start
- 14 Dec 2006
- Study completion
- 20 Aug 2008
- First posted
- 20 Dec 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- age between 18-40 years
- able to perform tasks required by the study
- willing and able to give consent
Key exclusion criteria (7 listed)
- unable to perform the tasks required by the study
- history of severe alcohol or drug abuse, psychiatric illness like severe depression, or severe language disturbances, particularly of receptive nature or with serious cognitive deficits (defined as equivalent to a mini-mental state exam score [MMSE] of 23 or less), or degenerative brain processes such as Alzheimer's disease
- severe uncontrolled medical problems (e.g., cardiovascular disease, severe rheumatoid arthritis, active joint deformity of arthritic origin, active cancer or renal disease, any kind of end-stage pulmonary or cardiovascular disease, or a deteriorated condition due to age, uncontrolled epilepsy or others), more than moderate to severe microangiopathy, polyneuropathy, diabetes mellitus, or ischemic peripheral disease
- problems with movement of the hands
- receiving drugs acting primarily on the central nervous system, which lower the seizure threshold, such as antipsychotic drugs (chlorpromazine, clozapine) or tricyclic antidepressants (for the TMS component only)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2017.
- Background: PubMed 15999258Fregni F, Boggio PS, Nitsche M, Bermpohl F, Antal A, Feredoes E, Marcolin MA, Rigonatti SP, Silva MT, Paulus W, Pascual-Leone A. Anodal transcranial direct current stimulation of prefrontal cortex enhances working memory. Exp Brain Res. 2005 Sep;166(1):23-30. doi: 10.1007/s00221-005-2334-6. Epub 2005 Jul 6.
- Background: PubMed 15147322Antal A, Nitsche MA, Kincses TZ, Kruse W, Hoffmann KP, Paulus W. Facilitation of visuo-motor learning by transcranial direct current stimulation of the motor and extrastriate visual areas in humans. Eur J Neurosci. 2004 May;19(10):2888-92. doi: 10.1111/j.1460-9568.2004.03367.x.
- Background: PubMed 16087918Khedr EM, Ahmed MA, Fathy N, Rothwell JC. Therapeutic trial of repetitive transcranial magnetic stimulation after acute ischemic stroke. Neurology. 2005 Aug 9;65(3):466-8. doi: 10.1212/01.wnl.0000173067.84247.36.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy, run by National Institute of Neurological Disorders and Stroke (NINDS) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00413842, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2017.