HealthyNCT03244501
Transcranial Static Magnetic Field Stimulation of Frontal Cortex
A study testing Active tSMS in people with Healthy, run by University of North Carolina, Chapel Hill at 1 site in United States.
Trial summary
The purpose of this study is to see if a new brain stimulation technique, static magnetic field stimulation (tSMS), which involves holding a static neodymium magnet over the scalp, can influence normal rhythms of brain activity. Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Active tSMS
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Aug 2017to 15 Sep 2017
- Phase
- Interventional
- 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 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Right-handed, healthy, 18+ years old
- 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
- Medical history of Psychological/Emotional Disorders (depression, anxiety, bipolar, etc.)
- (For females) Pregnancy or breast feeding
- 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 19Show 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
- Any metal in/on the body, e.g., dental braces, glasses, piercings
- Traumatic brain injury
- Thick hair that would create distance between the magnet and the scalp
- Taking hormonal birth control or hormonal supplements (e.g., testosterone injections) - 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.
About this study
Official title: Modulation of Frontal Cortical Activity With Transcranial Static Magnetic Field Stimulation
The purpose of this study is to see if a new brain stimulation technique, static magnetic field stimulation (tSMS), which involves holding a static neodymium magnet over the scalp, can influence normal rhythms of brain activity.
Read the detailed description
The investigator's primary objective is to determine the feasibility of modifying frontal brain activity using static magnetic fields. The investigator's will be examining the effects of static magnetic field of the spectral power of EEG data with healthy human participants.
This is a within-subjects design, where each participant will receive sham and active stimulation on the left and right frontal cortex. EEG data will be collected during each stimulation.
- Conditions
- Healthy
- Being tested
- Active tSMS, Sham tSMS
- Keywords
- tSMS, Transcranial Static Magnetic Field Stimulation, healthy control
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active tSMSOther
A cylindrical neodymium magnet is placed above the scalp.
Sham tSMSOther
A cylindrical piece of nonferrous metal (brass). This is not attracted to magnets, and is identical in weight and appearance to active magnets.
| Study group | Role | What they receive |
|---|---|---|
| Left Frontal | Experimental | An active magnet (active tSMS) will be placed over the left frontal cortex, while a sham magnet (sham tSMS, a nonmagnetic metal cylinder made of brass) will be placed over the right frontal cortex. Receives: Other: Active tSMS |
| Right Frontal | Experimental | An active magnet (active tSMS) will be placed over the right frontal cortex, while a sham magnet (sham tSMS, a nonmagnetic metal cylinder made of brass) will be placed over the left frontal cortex. Receives: Other: Active tSMS |
| Sham Frontal | Sham comparator | Sham magnets (sham tSMS, a nonmagnetic metal cylinder made of brass) will be placed over the left and right frontal cortex. Receives: Other: Sham tSMS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Electroencephalogram (EEG) Spectral Power
Changes in the spectral power of the EEG before (2 min eyes-closed, 2 min eyes-open), during (eyes-open), and after stimulation (eyes-open)
Measured: 4 minutes before stimulation, 10 minutes during stimulation, and 2 minutes after stimulation
Secondary outcomes (1)
Heart Rate Variability
Change in the ratio between the power in low frequency band and the power in high frequency band. As this outcome variable is a ratio between two items that are measured in microvolt^2, the ratio does not have a unit of measure.
Measured: 4 minutes before stimulation, 10 minutes during stimulation, and 2 minutes after stimulation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2017
- Study start8 Aug 2017
- Primary completion15 Sep 2017
- Study completion15 Sep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- All participants will receive three stimulations: left frontal, right frontal, and sham tSMS.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Flavio Frohlich, PhD, Study director, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03244501
- Sponsor's protocol ID
- 17-1022
- Status last verified
- Oct 2017
- First submitted
- 3 Aug 2017
- Last updated
- 26 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Modulation of Frontal Cortical Activity With Transcranial Static Magnetic Field Stimulation
- ClinicalTrials.gov ID
- NCT03244501
- Acronym / sponsor ID
- 17-1022
- Conditions
- Healthy
- Keywords
- tSMS, Transcranial Static Magnetic Field Stimulation, healthy control
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Study start
- 8 Aug 2017 (actual)
- Primary completion
- 15 Sep 2017 (actual)
- Study completion
- 15 Sep 2017 (actual)
- First posted
- 9 Aug 2017 (actual)
- 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.
The purpose of this study is to see if a new brain stimulation technique, static magnetic field stimulation (tSMS), which involves holding a static neodymium magnet over the scalp, can influence normal rhythms of brain activity.
Detailed description
The investigator's primary objective is to determine the feasibility of modifying frontal brain activity using static magnetic fields. The investigator's will be examining the effects of static magnetic field of the spectral power of EEG data with healthy human participants.
This is a within-subjects design, where each participant will receive sham and active stimulation on the left and right frontal cortex. EEG data will be collected during each stimulation.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
- Model description
- All participants will receive three stimulations: left frontal, right frontal, and sham tSMS.
| Arm | Type | Receives |
|---|---|---|
| Left Frontal | Experimental | Other: Active tSMSAn active magnet (active tSMS) will be placed over the left frontal cortex, while a sham magnet (sham tSMS, a nonmagnetic metal cylinder made of brass) will be placed over the right frontal cortex. |
| Right Frontal | Experimental | Other: Active tSMSAn active magnet (active tSMS) will be placed over the right frontal cortex, while a sham magnet (sham tSMS, a nonmagnetic metal cylinder made of brass) will be placed over the left frontal cortex. |
| Sham Frontal | Sham comparator | Other: Sham tSMSSham magnets (sham tSMS, a nonmagnetic metal cylinder made of brass) will be placed over the left and right frontal cortex. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Right-handed, healthy, 18+ years old
- 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
Key exclusion criteria (19 listed)
- Medical history of Psychological/Emotional Disorders (depression, anxiety, bipolar, etc.)
- (For females) Pregnancy or breast feeding
- 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 |
|---|---|---|
| Active tSMSA cylindrical neodymium magnet is placed above the scalp. | Other | Left Frontal, Right Frontal |
| Sham tSMSA cylindrical piece of nonferrous metal (brass). This is not attracted to magnets, and is identical in weight and appearance to active magnets. | Other | Sham Frontal |
Primary outcome
Electroencephalogram (EEG) Spectral Power
Time frame: 4 minutes before stimulation, 10 minutes during stimulation, and 2 minutes after stimulation
Changes in the spectral power of the EEG before (2 min eyes-closed, 2 min eyes-open), during (eyes-open), and after stimulation (eyes-open)
1 secondary outcome
Heart Rate Variability
Time frame: 4 minutes before stimulation, 10 minutes during stimulation, and 2 minutes after stimulation
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 26 Oct 2017.
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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 study director
University of North Carolina, Chapel Hill
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active tSMS in people with Healthy, 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 3 inclusion and 19 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 26 Oct 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. 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?
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.
What does the primary outcome measure?
Electroencephalogram (EEG) Spectral Power (time frame: 4 minutes before stimulation, 10 minutes during stimulation, and 2 minutes after stimulation). 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 26 Oct 2017; AzTrials last refreshed its copy on 4 Nov 2026.