HealthyNCT04586387
The Effect of Brain Anatomy on the Efficacy of Brain Stimulation Therapy
A study of Healthy, run by Virginia Commonwealth University at 1 site in United States.
Trial summary
The purpose of this research study is to determine whether brain anatomy impacts the efficacy of transcranial magnetic stimulation (TMS) which is a form of non-invasive brain stimulation. TMS is used to stimulate different areas of the brain and it is well tolerated and generally a safe procedure. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Nov 2020to 8 Jul 2022
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- nonimpaired individuals
- free of contraindications for MRI and TMS
Who cannot join
- musculoskeletal injury of the arm
- neurologic deficit affecting motor or sensory function
- concurrent severe medical illness
- diagnosis of SARS-CoV2, or symptoms consistent with COVID-19, or close contact with someone with SARS-CoV2 in the past 3 weeks
Trial locations and contacts
1 site in 1 country.
United States1 site
Virginia Commonwealth University
Richmond, Virginia, 23298
About this study
The purpose of this research study is to determine whether brain anatomy impacts the efficacy of transcranial magnetic stimulation (TMS) which is a form of non-invasive brain stimulation. TMS is used to stimulate different areas of the brain and it is well tolerated and generally a safe procedure. It has been studied by researchers for 20 plus years. This brain stimulation device and technique used in this study is an investigational device that has not been approved by the U.S. FDA for treating any muscle or nerve problems. A copy of the device brochure can be found at: https://www.magstim.com/product/rapid-family/
- Conditions
- Healthy
- Being tested
- intermittent theta burst stimulation (iTBS) with sham and then active stimulation over bicep muscle, intermittent theta burst stimulation (iTBS) with sham and then active stimulation over finger muscle
- Keywords
- transcranial magnetic stimulation, non-invasive brain stimulation, magnetic resonance imaging
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intermittent theta burst stimulation (iTBS) with sham and then active stimulation over bicep muscleDevice
repetitive non-invasive brain stimulation protocol which feels like many quick, light taps on your head
intermittent theta burst stimulation (iTBS) with sham and then active stimulation over finger muscleDevice
repetitive non-invasive brain stimulation protocol which feels like many quick, light taps on your head
| Study group | Role | What they receive |
|---|---|---|
| Brain stimulation over bicep muscle than finger (FDI) muscle. | Experimental | Brain stimulation will occur over two sessions. Both sessions will occur with sham stimulation then active stimulation. There will be a 3 day rest period between the two muscle groups. Receives: Device: intermittent theta burst stimulation (iTBS) with sham and then active stimulation over bicep muscle; Device: intermittent theta burst stimulation (iTBS) with sham and then active stimulation over finger muscle |
| Brain stimulation over than finger (FDI) muscle than bicep muscle. | Experimental | Brain stimulation will occur over two sessions. Both sessions will occur with sham stimulation then active stimulation. There will be a 3 day rest period between the two muscle groups. Receives: Device: intermittent theta burst stimulation (iTBS) with sham and then active stimulation over bicep muscle; Device: intermittent theta burst stimulation (iTBS) with sham and then active stimulation over finger muscle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Corticomotor Excitability With Active Stimulation on Bicep Muscle
The amplitude the motor evoked potentials (MEPS) will be used to determine level of corticomotor excitability
Measured: approximately 7 days
Change in Corticomotor Excitability With Sham Stimulation on Bicep Muscle
The amplitude the motor evoked potentials (MEPS) will be used to determine level of corticomotor excitability
Measured: approximately 7 days
Change in Corticomotor Excitability With Active Stimulation on Finger Muscle
The amplitude the motor evoked potentials (MEPS) will be used to determine level of corticomotor excitability
Measured: approximately 7 days
Change in Corticomotor Excitability With Sham Stimulation on Finger Muscle
The amplitude the motor evoked potentials (MEPS) will be used to determine level of corticomotor excitability
Measured: approximately 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2020
- Study start9 Nov 2020
- Primary completion8 Jul 2022
- Study completion8 Jul 2022
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 HealthyStudies of the same condition, open and under way.
- More trials run by Virginia Commonwealth UniversityThe 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
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Virginia Commonwealth University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Carrie Peterson, PhD, Principal investigator, Virginia Commonwealth University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04586387
- Sponsor's protocol ID
- HM20018505
- Status last verified
- May 2024
- First submitted
- 7 Oct 2020
- Last updated
- 3 May 2024
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Brain Anatomy on the Efficacy of Brain Stimulation Therapy
- ClinicalTrials.gov ID
- NCT04586387
- Acronym / sponsor ID
- HM20018505
- Conditions
- Healthy
- Keywords
- transcranial magnetic stimulation, non-invasive brain stimulation, magnetic resonance imaging
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Virginia Commonwealth UniversityUniversity, hospital or other
- Study start
- 9 Nov 2020 (actual)
- Primary completion
- 8 Jul 2022 (actual)
- Study completion
- 8 Jul 2022 (actual)
- First posted
- 14 Oct 2020 (actual)
- Results
- Posted 18 Dec 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this research study is to determine whether brain anatomy impacts the efficacy of transcranial magnetic stimulation (TMS) which is a form of non-invasive brain stimulation. TMS is used to stimulate different areas of the brain and it is well tolerated and generally a safe procedure. It has been studied by researchers for 20 plus years. This brain stimulation device and technique used in this study is an investigational device that has not been approved by the U.S. FDA for treating any muscle or nerve problems. A copy of the device brochure can be found at: https://www.magstim.com/product/rapid-family/
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Brain stimulation over bicep muscle than finger (FDI) muscle. | Experimental | Device: intermittent theta burst stimulation (iTBS) with sham and then active stimulation over bicep muscle, Device: intermittent theta burst stimulation (iTBS) with sham and then active stimulation over finger muscleBrain stimulation will occur over two sessions. Both sessions will occur with sham stimulation then active stimulation. There will be a 3 day rest period between the two muscle groups. |
| Brain stimulation over than finger (FDI) muscle than bicep muscle. | Experimental | Device: intermittent theta burst stimulation (iTBS) with sham and then active stimulation over bicep muscle, Device: intermittent theta burst stimulation (iTBS) with sham and then active stimulation over finger muscleBrain stimulation will occur over two sessions. Both sessions will occur with sham stimulation then active stimulation. There will be a 3 day rest period between the two muscle groups. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- nonimpaired individuals
- free of contraindications for MRI and TMS
Key exclusion criteria (4 listed)
- musculoskeletal injury of the arm
- neurologic deficit affecting motor or sensory function
- concurrent severe medical illness
- diagnosis of SARS-CoV2, or symptoms consistent with COVID-19, or close contact with someone with SARS-CoV2 in the past 3 weeks
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 |
|---|---|---|
| intermittent theta burst stimulation (iTBS) with sham and then active stimulation over bicep musclerepetitive non-invasive brain stimulation protocol which feels like many quick, light taps on your head | Device | Brain stimulation over bicep muscle than finger (FDI) muscle., Brain stimulation over than finger (FDI) muscle than bicep muscle. |
| intermittent theta burst stimulation (iTBS) with sham and then active stimulation over finger musclerepetitive non-invasive brain stimulation protocol which feels like many quick, light taps on your head | Device | Brain stimulation over bicep muscle than finger (FDI) muscle., Brain stimulation over than finger (FDI) muscle than bicep muscle. |
Primary outcome
Change in Corticomotor Excitability With Active Stimulation on Bicep Muscle
Time frame: approximately 7 days
The amplitude the motor evoked potentials (MEPS) will be used to determine level of corticomotor excitability
Change in Corticomotor Excitability With Sham Stimulation on Bicep Muscle
Time frame: approximately 7 days
The amplitude the motor evoked potentials (MEPS) will be used to determine level of corticomotor excitability
Change in Corticomotor Excitability With Active Stimulation on Finger Muscle
Time frame: approximately 7 days
The amplitude the motor evoked potentials (MEPS) will be used to determine level of corticomotor excitability
Change in Corticomotor Excitability With Sham Stimulation on Finger Muscle
Time frame: approximately 7 days
The amplitude the motor evoked potentials (MEPS) will be used to determine level of corticomotor excitability
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Carrie Peterson, PhD principal investigator
Virginia Commonwealth University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Healthy, run by Virginia Commonwealth University 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 2 inclusion and 4 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 3 May 2024. 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?
Yes. Results are posted in the registry (first posted 18 Dec 2023). 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?
Change in Corticomotor Excitability With Active Stimulation on Bicep Muscle (time frame: approximately 7 days). The study lists 4 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 3 May 2024.