HealthyAIMS1NCT03178344
Effect of tACS Stimulation on Alpha Oscillations
A study testing XCSITE100 Stimulator tACS in people with Healthy, run by University of North Carolina, Chapel Hill at 1 site in United States.
Trial summary
Transcranial Alternating Current Stimulation (tACS) is one method that has been demonstrated to enhance alpha oscillations in healthy participants by applying weak electrical currents to the scalp to modulate rhythmic brain activity patterns. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- XCSITE100 Stimulator tACS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2017to 4 Nov 2017
- 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
- Ages 18-65
- Capacity to understand all relevant risks and potential benefits of the study (informed consent)
- Negative pregnancy test for female participants
Who cannot join
- History of major neurological or psychiatric illness, including epilepsy
- Medication use associated with neurological or psychiatric illnesses
- Currently undergoing counseling or psychotherapy treatment for depression, anxiety, eating disorders, PTSD or other behavioral conditions
- First degree relative (parent, sibling, child) with major neurological or psychiatric illness
- Prior brain surgery
- Major head injury
Show all 14Show fewer
- Any brain devices/implants (including cochlear implants and aneurysm clips)
- Braids or other hair styling that prevents direct access to the scalp (if removal not possible)
- Skin allergies or very sensitive skin
- Pregnant or nursing females
- Failure to pass a urinary drug test at the first session
- Use of hormonal birth control or supplements in the past two weeks
- Non English speakers
- Cardiovascular disease
Trial locations and contacts
1 site in 1 country.
United States1 site
University of North Carolina Chapel Hill
Chapel Hill, North Carolina, 27514
About this study
Official title: Rational Optimization of tACS for Targeting Thalamo-Cortical Oscillations (Experiment 2)
Transcranial Alternating Current Stimulation (tACS) is one method that has been demonstrated to enhance alpha oscillations in healthy participants by applying weak electrical currents to the scalp to modulate rhythmic brain activity patterns. This study will involve tACS-induced frontal alpha oscillations, EEG recordings, and other physiological and biological measures.
- Conditions
- Healthy
- Being tested
- XCSITE100 Stimulator tACS, XCSITE100 Stimulator Sham
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
XCSITE100 Stimulator tACSDevice
Also called tACS
Transcranial alternating current stimulation (tACS) is a method of noninvasive brain stimulation in which weak electrical current are applied to the scalp in a sine wave pattern to induce cortical oscillations at the frequency at which they are applied.
XCSITE100 Stimulator ShamDevice
Also called Sham tACS
The participant will receive up to one minute of tACS stimulation until the stimulation fades. Sham stimulation mimics the skin sensations a participant would experience during a tACS session.
| Study group | Role | What they receive |
|---|---|---|
| Sham Stimulation, then Alpha Stimulation | Experimental | Participants receive sham stimulation at the first session, followed by a 5-9 day washout period and alpha stimulation at the second session.
Sham Stimulation mimics the physical effects of stimulation, with up to one minute of stimulation during the session. Sham stimulation is delivered using the XCSITE100 Stimulator Sham.
Participants will receive 2 mA of alternating current stimulation at a frequency of 10 Hz for 40 minutes. tACS stimulation is delivered using the XCSITE100 Stimulator tACS. Receives: Device: XCSITE100 Stimulator tACS; Device: XCSITE100 Stimulator Sham |
| Alpha Stimulation, then Sham Stimulation | Experimental | Participants receive alpha stimulation at the first session, followed by a 5-9 day washout period and sham stimulation at the second session.
Participants will receive 2 mA of alternating current stimulation at a frequency of 10 Hz for 40 minutes. tACS stimulation is delivered using the XCSITE100 Stimulator tACS.
Sham Stimulation mimics the physical effects of stimulation, with up to one minute of stimulation during the session. Sham stimulation is delivered using the XCSITE100 Stimulator Sham. Receives: Device: XCSITE100 Stimulator tACS; Device: XCSITE100 Stimulator Sham |
What is being measured
The primary outcome is the main question the study is designed to answer.
Salivary Alpha Amylase
Change after stimulation
Measured: Before and after 40-minute stimulation at each session.
Salivary Cortisol
Change before and after stimulation
Measured: Before and after 40 minutes of stimulation
Secondary outcomes (3)
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: Before and after 40-minute stimulation at each session.
Percent Change in Respiration
Respiration rate, measured via a belt placed around the participant's abdomen as breaths per second.
Measured: Before and after 40-minute stimulation at each session.
Electroencephalogram (EEG)
The investigators will compare alpha oscillation power from resting-state EEG recordings before and after stimulation/sham at each session.
Measured: Before and after 40-minute stimulation 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 posted6 Jun 2017
- Study start1 Aug 2017
- Primary completion4 Nov 2017
- Study completion4 Nov 2017
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.
- 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 receive sham stimulation or 10 Hz tACS stimulation at two separate sessions. The order will be randomized (ie, half the participants will receive sham stimulation at the first session and 10 Hz tACS stimulation at the second session, and the other half will receive 10 Hz tACS stimulation at the first session and sham stimulation at the second session).
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- Flavio Frohlich, PhD, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03178344
- Sponsor's protocol ID
- 16-1911a
- Other IDs
- R01MH111889-01
- Acronym
- AIMS1
- Status last verified
- Feb 2018
- First submitted
- 2 Jun 2017
- Last updated
- 26 Feb 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: IPD will not be shared with other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rational Optimization of tACS for Targeting Thalamo-Cortical Oscillations (Experiment 2)
- ClinicalTrials.gov ID
- NCT03178344
- Acronym / sponsor ID
- AIMS1 / 16-1911a
- Conditions
- Healthy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute of Mental Health (NIMH)
- Study start
- 1 Aug 2017 (actual)
- Primary completion
- 4 Nov 2017 (actual)
- Study completion
- 4 Nov 2017 (actual)
- First posted
- 6 Jun 2017 (actual)
- Results
- Posted 7 Dec 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Transcranial Alternating Current Stimulation (tACS) is one method that has been demonstrated to enhance alpha oscillations in healthy participants by applying weak electrical currents to the scalp to modulate rhythmic brain activity patterns. This study will involve tACS-induced frontal alpha oscillations, EEG recordings, and other physiological and biological measures.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Each participant will receive sham stimulation or 10 Hz tACS stimulation at two separate sessions. The order will be randomized (ie, half the participants will receive sham stimulation at the first session and 10 Hz tACS stimulation at the second session, and the other half will receive 10 Hz tACS stimulation at the first session and sham stimulation at the second session).
| Arm | Type | Receives |
|---|---|---|
| Sham Stimulation, then Alpha Stimulation | Experimental | Device: XCSITE100 Stimulator tACS, Device: XCSITE100 Stimulator ShamParticipants receive sham stimulation at the first session, followed by a 5-9 day washout period and alpha stimulation at the second session. Sham Stimulation mimics the physical effects of stimulation, with up to one minute of stimulation during the session. Sham stimulation is delivered using the XCSITE100 Stimulator Sham. Participants will receive 2 mA of alternating current stimulation at a frequency of 10 Hz for 40 minutes. tACS stimulation is delivered using the XCSITE100 Stimulator tACS. |
| Alpha Stimulation, then Sham Stimulation | Experimental | Device: XCSITE100 Stimulator tACS, Device: XCSITE100 Stimulator ShamParticipants receive alpha stimulation at the first session, followed by a 5-9 day washout period and sham stimulation at the second session. Participants will receive 2 mA of alternating current stimulation at a frequency of 10 Hz for 40 minutes. tACS stimulation is delivered using the XCSITE100 Stimulator tACS. Sham Stimulation mimics the physical effects of stimulation, with up to one minute of stimulation during the session. Sham stimulation is delivered using the XCSITE100 Stimulator Sham. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Ages 18-65
- Capacity to understand all relevant risks and potential benefits of the study (informed consent)
- Negative pregnancy test for female participants
Key exclusion criteria (14 listed)
- History of major neurological or psychiatric illness, including epilepsy
- Medication use associated with neurological or psychiatric illnesses
- Currently undergoing counseling or psychotherapy treatment for depression, anxiety, eating disorders, PTSD or other behavioral conditions
- First degree relative (parent, sibling, child) with major neurological or psychiatric illness
- Prior brain surgery
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 |
|---|---|---|
| XCSITE100 Stimulator tACSAlso: tACSTranscranial alternating current stimulation (tACS) is a method of noninvasive brain stimulation in which weak electrical current are applied to the scalp in a sine wave pattern to induce cortical oscillations at the frequency at which they are applied. | Device | Alpha Stimulation, then Sham Stimulation, Sham Stimulation, then Alpha Stimulation |
| XCSITE100 Stimulator ShamAlso: Sham tACSThe participant will receive up to one minute of tACS stimulation until the stimulation fades. Sham stimulation mimics the skin sensations a participant would experience during a tACS session. | Device | Alpha Stimulation, then Sham Stimulation, Sham Stimulation, then Alpha Stimulation |
Primary outcome
Salivary Alpha Amylase
Time frame: Before and after 40-minute stimulation at each session.
Change after stimulation
Salivary Cortisol
Time frame: Before and after 40 minutes of stimulation
Change before and after stimulation
3 secondary outcomes
Heart Rate Variability
Time frame: Before and after 40-minute stimulation at each session.
Percent Change in Respiration
Time frame: Before and after 40-minute stimulation at each session.
Electroencephalogram (EEG)
Time frame: Before and after 40-minute stimulation at each session.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. IPD will not be shared with other researchers.
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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, 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 XCSITE100 Stimulator tACS 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 14 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 Feb 2019. 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 7 Dec 2018). 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?
Salivary Alpha Amylase (time frame: Before and after 40-minute stimulation 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 26 Feb 2019.