Motor ActivityNCT03481309
Modulation of Motor Cortex Excitability by TMS and tDCS (MAGS1)
A study testing anodal tDCS and cathodal tDCS in people with Motor Activity and Motor Neuroplasticity, run by University of North Carolina, Chapel Hill at 1 site in United States.
Trial summary
Investigating modulation of motor cortex excitability by transcranial magnetic stimulation and transcranial direct current stimulation. Read more about this study
- Who is it for?
- Ages 18 to 35 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Motor Activity, Motor Neuroplasticity
- What is being tested?
- anodal tDCS and cathodal tDCS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 19 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Aug 2018to 1 Feb 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 35 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male
- Between the ages of 18 and 35
- Right-handed
- Capacity to understand all relevant risks and potential benefits of the study (informed consent)
- Willing to comply with all study procedures and be available for the duration of the study
- Speak and understand English
Who cannot join
- Prior concussion
- Diagnosis of eating disorder (current or within the past 6 months)
- Diagnosis of obsessive compulsive disorder (lifetime)
- Attention-deficit/hyperactivity disorder (currently under treatment)
- Neurological disorders and conditions, including, but not limited to:
- History of epilepsy
Show all 18Show fewer
- Seizures (except childhood febrile seizures and electroconvulsive therapy-induced seizures)
- Dementia
- History of stroke
- Parkinson's disease
- Multiple sclerosis
- Cerebral aneurysm
- Brain tumors
- Medical or neurological illness or treatment for a medical disorder that could interfere with study participation (e.g., unstable cardiac disease, HIV/AIDS, malignancy, liver or renal impairment)
- Prior brain surgery
- Any brain devices/implants, including cochlear implants and aneurysm clips
- Traumatic brain injury
- Anything that, in the opinion of the investigator, would place the participant at increased risk or preclude the participant's full compliance with or completion of the study
Trial locations and contacts
1 site in 1 country.
United States1 site
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599
About this study
Official title: Modulation of Motor Cortex Excitability by Transcranial Magnetic Stimulation and Transcranial Direct Current Stimulation
Investigating modulation of motor cortex excitability by transcranial magnetic stimulation and transcranial direct current stimulation.
Read the detailed description
Purpose of this pilot study is to modulate the motor cortex excitability by transcranial magnetic stimulation and transcranial direct current stimulation. Electromyography will be recorded on right abductor digiti minimi muscle to find the motor threshold and measure motor evoked potentials for each healthy participant. In addition, electroencephalography (EEG) data will be collected on the scalp with a high-density EEG net. Eighteen healthy participants will be in this study. Each participant will be seated in a reclining chair and applied non-invasive magnetic and electrical stimulations on the scalp. At baseline, the participant's resting motor threshold (RMT) will be estimated by adjusting the intensity of TMS applied on the left motor cortex to achieve motor-evoked potentials of about 50 uV with 10 TMS pulses at a rate of 0.25 Hz. Then a 3-condition, 3-session, 6-sequence randomized crossover experiment will be used to characterize and compare three versions of tDCS stimulation: anode, cathode, sham. Before and after a 10-min tDCS condition is applied, TMS pulses at 120% of RMT intensity will be applied for 10 minutes and TMS-evoked potential and motor-evoked potential amplitudes will be measured. Each session has at least 1-day gap to remove outlasting effects. We will also be collecting structural magnetic resonance imaging (sMRI) to target primary motor cortex precisely.
- Conditions
- Motor Activity, Motor Neuroplasticity
- Being tested
- anodal tDCS, cathodal tDCS, sham tDCS
- Keywords
- transcranial magnetic stimulation (TMS), transcranial direct current stimulation (tDCS), electroencephalography (EEG)
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
anodal tDCSDevice
The participant will receive anodal tDCS with 2 mA for 10 minutes on the left motor cortex.
cathodal tDCSDevice
The participant will receive cathodal tDCS with -2 mA for 10 minutes on the left motor cortex.
sham tDCSDevice
The participant will receive sham tDCS with 2 mA for 40 seconds on the left motor cortex which mimics the skin sensations as active tDCS interventions.
| Study group | Role | What they receive |
|---|---|---|
| anodal tDCS | Active comparator | Two electrodes will be applied to the scalp (one on the left motor cortex, one on the right supraorbital cortex). This anodal tDCS on the left motor cortex will be stimulated with 2mA for 10 minutes. Receives: Device: anodal tDCS |
| cathodal tDCS | Active comparator | Two electrodes will be applied to the scalp (one on the left motor cortex, one on the right supraorbital cortex). This cathodal tDCS on the left motor cortex will be stimulated with -2mA for 10 minutes. Receives: Device: cathodal tDCS |
| sham tDCS | Sham comparator | Two electrodes will be applied to the scalp (one on the left motor cortex, one on the right supraorbital cortex). Sham stimulation with 2mA for 40 seconds will be applied. Receives: Device: sham tDCS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Motor-evoked Potentials Ratios
The investigators will record motor-evoked potentials and calculate changes in between before and after 2mA tDCS stimulation for 10 minutes.
Measured: right before and after 2mA tDCS stimulation for 10 minutes at each session
Changes in TMS-evoked Potentials Ratios
The investigators will record TMS-evoked potentials using EEG and calculate changes in between before and after 2mA tDCS stimulation for 10 minutes.
Measured: right before and after 2mA tDCS stimulation for 10 minutes at each session
Secondary outcomes (1)
Changes in Resting-state EEG Dynamics Ratios
The investigators will record participants' resting state for 4 minutes using EEG (2 minutes for eyes-closed and 2 minutes for eyes-open)
Measured: 4 minutes recordings before and after each 2mA tDCS stimulation for 10 minutes at each session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2018
- Study start24 Aug 2018
- Primary completion31 Jan 2019
- Study completion1 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Motor ActivityStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Each participant will be assigned to 2 active and sham conditions on a different day.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- Flavio Frohlich, PhD, Principal investigator, University of North Carolina at Chapel Hill - Department of Psychiatry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03481309
- Sponsor's protocol ID
- 17-0149
- Other IDs
- R01MH101547
- Status last verified
- Feb 2021
- First submitted
- 9 Mar 2018
- Last updated
- 4 Mar 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Modulation of Motor Cortex Excitability by Transcranial Magnetic Stimulation and Transcranial Direct Current Stimulation
- ClinicalTrials.gov ID
- NCT03481309
- Acronym / sponsor ID
- 17-0149
- Conditions
- Motor Activity, Motor Neuroplasticity
- Keywords
- transcranial magnetic stimulation (TMS), transcranial direct current stimulation (tDCS), electroencephalography (EEG)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 24 Aug 2018 (actual)
- Primary completion
- 31 Jan 2019 (actual)
- Study completion
- 1 Feb 2019 (actual)
- First posted
- 29 Mar 2018 (actual)
- Results
- Posted 23 Oct 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Investigating modulation of motor cortex excitability by transcranial magnetic stimulation and transcranial direct current stimulation.
Detailed description
Purpose of this pilot study is to modulate the motor cortex excitability by transcranial magnetic stimulation and transcranial direct current stimulation. Electromyography will be recorded on right abductor digiti minimi muscle to find the motor threshold and measure motor evoked potentials for each healthy participant. In addition, electroencephalography (EEG) data will be collected on the scalp with a high-density EEG net. Eighteen healthy participants will be in this study. Each participant will be seated in a reclining chair and applied non-invasive magnetic and electrical stimulations on the scalp. At baseline, the participant's resting motor threshold (RMT) will be estimated by adjusting the intensity of TMS applied on the left motor cortex to achieve motor-evoked potentials of about 50 uV with 10 TMS pulses at a rate of 0.25 Hz. Then a 3-condition, 3-session, 6-sequence randomized crossover experiment will be used to characterize and compare three versions of tDCS stimulation: anode, cathode, sham. Before and after a 10-min tDCS condition is applied, TMS pulses at 120% of RMT intensity will be applied for 10 minutes and TMS-evoked potential and motor-evoked potential amplitudes will be measured. Each session has at least 1-day gap to remove outlasting effects. We will also be collecting structural magnetic resonance imaging (sMRI) to target primary motor cortex precisely.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Each participant will be assigned to 2 active and sham conditions on a different day.
| Arm | Type | Receives |
|---|---|---|
| anodal tDCS | Active comparator | Device: anodal tDCSTwo electrodes will be applied to the scalp (one on the left motor cortex, one on the right supraorbital cortex). This anodal tDCS on the left motor cortex will be stimulated with 2mA for 10 minutes. |
| cathodal tDCS | Active comparator | Device: cathodal tDCSTwo electrodes will be applied to the scalp (one on the left motor cortex, one on the right supraorbital cortex). This cathodal tDCS on the left motor cortex will be stimulated with -2mA for 10 minutes. |
| sham tDCS | Sham comparator | Device: sham tDCSTwo electrodes will be applied to the scalp (one on the left motor cortex, one on the right supraorbital cortex). Sham stimulation with 2mA for 40 seconds will be applied. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Male
- Between the ages of 18 and 35
- Right-handed
- Capacity to understand all relevant risks and potential benefits of the study (informed consent)
- Willing to comply with all study procedures and be available for the duration of the study
Key exclusion criteria (18 listed)
- Prior concussion
- Diagnosis of eating disorder (current or within the past 6 months)
- Diagnosis of obsessive compulsive disorder (lifetime)
- Attention-deficit/hyperactivity disorder (currently under treatment)
- Neurological disorders and conditions, including, but not limited to:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| anodal tDCSThe participant will receive anodal tDCS with 2 mA for 10 minutes on the left motor cortex. | Device | anodal tDCS |
| cathodal tDCSThe participant will receive cathodal tDCS with -2 mA for 10 minutes on the left motor cortex. | Device | cathodal tDCS |
| sham tDCSThe participant will receive sham tDCS with 2 mA for 40 seconds on the left motor cortex which mimics the skin sensations as active tDCS interventions. | Device | sham tDCS |
Primary outcome
Changes in Motor-evoked Potentials Ratios
Time frame: right before and after 2mA tDCS stimulation for 10 minutes at each session
The investigators will record motor-evoked potentials and calculate changes in between before and after 2mA tDCS stimulation for 10 minutes.
Changes in TMS-evoked Potentials Ratios
Time frame: right before and after 2mA tDCS stimulation for 10 minutes at each session
The investigators will record TMS-evoked potentials using EEG and calculate changes in between before and after 2mA tDCS stimulation for 10 minutes.
1 secondary outcome
Changes in Resting-state EEG Dynamics Ratios
Time frame: 4 minutes recordings before and after each 2mA tDCS stimulation for 10 minutes at each session
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Flavio Frohlich, PhD principal investigator
University of North Carolina at Chapel Hill - Department of Psychiatry
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing anodal tDCS and cathodal tDCS in people with Motor Activity and Motor Neuroplasticity, run by University of North Carolina, Chapel Hill 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 6 inclusion and 18 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 4 Mar 2021. 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. Some participants in this study may receive a placebo. 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?
Yes. Results are posted in the registry (first posted 23 Oct 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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.
What does the primary outcome measure?
Changes in Motor-evoked Potentials Ratios (time frame: right before and after 2mA tDCS stimulation for 10 minutes at each session). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Mar 2021.