HealthyPACSNCT03135639
Effects of Alpha tACS
A study testing NeuroConn Plus Stimulator tACS in people with Healthy, run by University of North Carolina, Chapel Hill.
Trial summary
**Follow-up Control Study for Creativity Study Purpose: To investigate the effect of transcranial alternating current stimulation (tACS), a form of noninvasive brain stimulation, in healthy subjects. This experiment is a follow-up to previous tACS studies that used a creativity assessment. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- NeuroConn Plus Stimulator tACS
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- No sites listed yet
- Study dates
- Aug 2016to Apr 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Males and females at least 18 years of age
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 behavior conditions
- First degree relative (parent, sibling, child) with neurological or psychiatric illness (past and present)
- Prior brain surgery
- Head injury
Show all 9Show fewer
- Any brain devices/implants (including cochlear implants and aneurysm clips)
- Cardiovascular disease
- Pregnancy
About this study
Official title: Evaluating Transcranial Alternating Current Stimulation (tACS) for Enhancing Creativity
**Follow-up Control Study for Creativity Study
Purpose: To investigate the effect of transcranial alternating current stimulation (tACS), a form of noninvasive brain stimulation, in healthy subjects. This experiment is a follow-up to previous tACS studies that used a creativity assessment.
Read more
Participants: 35 males and females, at least 18 years of age, without history of major psychiatric/neurological disease or associated medication use, or prior brain surgery/implants.
Procedures (methods): This is a cross-over study design. Participants will undergo a control condition of stimulation (sham or individual alpha, 8-12 Hz, tACS) during electroencephalogram recordings. In addition, pupil diameter, heart rate, and respiration will be measured continuously. This is to study the physiological effects of stimulation.
Read the detailed description
Participants will report for a study visit. They will review and sign a consent form.
They will first be fitted with two 5x7cm electrodes placed over occipital and parietal cortex (Cz and Oz). They will also be fitted with ECG electrodes as well as a respiration belt. In addition, they will have a 128-channel EEG net placed on their head and pupillometry glasses. Once the participant is fitted with this equipment, they will complete a 2-minute resting state EEG with their eyes closed to determine their individual alpha frequency. Following the individual alpha frequency determination, the participant will fill out an alertness questionnaire, followed by 3 EEG recordings:
- 5 minute before stimulation recording
- 20 minute recording during stimulation; either at their individual alpha frequency (between 8 and 12 Hz) or sham stimulation.
- 5 minute after stimulation recording
Following these three recordings, the participant will have a 20 minute break in which they will read neutral reading material or converse with the study staff, as well as provide a saliva sample to test for brain derived neurotropic factor (BDNF).
After the 20 minute break, the participant will complete the alertness questionnaire, and the three recordings will be completed again. The participant will then be allowed to clean up, be paid, and leave.
------------------------
Clarification for the Experimental Design:
This part of the study is a control condition that will consist of stimulation over occipital and parietal cortex with electrodes over Cz and Oz. Participants will then receive 2mA alternating current stimulation between 8Hz and 12Hz (based on their individual alpha frequency determined by a 2 min eyes closed recording) or sham stimulation for 20 minutes (approximately the duration of the TTCT test) in a resting condition where they will have to focus on a cross hair on a computer screen. EEG will be collected simultaneously during this.
In both conditions, the participants wear a Pupil eye tracking headset, which is commercially available. This allows to monitor eye movements and to obtain physiological relevant measures of the pupil.
To obtain a measure of the heart rate during both conditions, ECG electrodes as part of the EEG acquisition system are placed on the participant's body. Ideally one electrode below the left collarbone and a second below the right chest.
Respiration Effort is measured in both conditions by a SleepSense sleep-lab sensor that is placed with an elastic band over the participants chest and connected to the EEG acquisition system.
Before each session, a questionnaire will be administered to the participant to assess the alertness state.
The entire procedure will be conducted by study personnel with documented training using brain stimulators and EEG.
- Conditions
- Healthy
- Being tested
- NeuroConn Plus Stimulator tACS, NeuroConn Plus Stimulator Sham
- Keywords
- tACS, transcranial alternating current stimulation, stimulation, healthy control, alpha oscillations, heart rate variability
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NeuroConn Plus Stimulator tACSOther
Also called tACS
Transcranial alternating current stimulation (tACS) is a novel, noninvasive brain stimulation approach in which weak electric currents are applied to the scalp. The electric currents that are applied to the scalp are in a sine-wave pattern.
NeuroConn Plus Stimulator ShamOther
Also called Sham tACS
For sham stimulation, the participant receives up to 1 minute of tACS stimulation until the stimulation fades. This mimics the same skin sensations that a participant would experience during a tACS session.
| Study group | Role | What they receive |
|---|---|---|
| Sham Stim followed by Alpha Stim | Experimental | 20 minutes of sham stimulation (sham stim) is followed by a washout period of 20 minutes. 20 minutes of alpha stimulation (alpha stim) is applied next.
Sham stimulation mimics the physical effects of stimulation, with up to 1 minute of stimulation during the session. Sham stimulation is delivered using the NeuroConn Plus Stimulator Sham.
Participants will receive 2 mA alternating current stimulation at their individual alpha frequency (8-12 Hz, as determined by the 2 minute resting state EEG) for 20 minutes. Alpha stimulation is delivered using the NeuroConn Plus Stimulator tACS. Receives: Other: NeuroConn Plus Stimulator tACS; Other: NeuroConn Plus Stimulator Sham |
| Alpha Stim followed by Sham Stim | Experimental | 20 minutes of alpha stimulation (alpha stim) is followed by a washout period of 20 minutes. 20 minutes of sham stimulation (sham stim) is applied next.
Participants will receive 2 mA alternating current stimulation at their individual alpha frequency (8-12 Hz, as determined by the 2 minute resting state EEG) for 20 minutes. Alpha stimulation is delivered using the NeuroConn Plus Stimulator tACS.
Sham stimulation mimics the physical effects of stimulation, with up to 1 minute of stimulation during the session. Sham stimulation is delivered using the NeuroConn Plus Stimulator Sham. Receives: Other: NeuroConn Plus Stimulator tACS; Other: NeuroConn Plus Stimulator Sham |
What is being measured
The primary outcome is the main question the study is designed to answer.
Electroencephalogram power in alpha band
Changes in the EEG power in the alpha (8-12 Hz) band before and after stimulation sessions.
Measured: 5 minute recordings before and after each 20 minute stimulation session during a single study visit.
Secondary outcomes (2)
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: 5 minute recordings before and after each 20 minute stimulation session during a single study visit.
Pupil diameter
Pupil diameter is associated with arousal. We will look to see what the changes in arousal are before and after stimulation sessions.
Measured: 5 minute recordings before and after each 20 minute stimulation session during a single study visit.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2017
- Study startAug 2016
- Primary completionApr 2017
- Study completionApr 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.
- 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 stimulation at their individual alpha frequency (8-12 Hz) during a study visit. The order is randomized (i.e., half of participants will receive sham stimulation during the first stimulation session and half will receive sham stimulation during the second stimulation session).
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 32 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, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03135639
- Sponsor's protocol ID
- 13-3918
- Acronym
- PACS
- Status last verified
- Apr 2017
- First submitted
- 20 Apr 2017
- Last updated
- 19 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD will be shared upon request.
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating Transcranial Alternating Current Stimulation (tACS) for Enhancing Creativity
- ClinicalTrials.gov ID
- NCT03135639
- Acronym / sponsor ID
- PACS / 13-3918
- Conditions
- Healthy
- Keywords
- tACS, transcranial alternating current stimulation, stimulation, healthy control, alpha oscillations, heart rate variability
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Study start
- Aug 2016 (actual)
- Primary completion
- Apr 2017 (actual)
- Study completion
- Apr 2017 (actual)
- First posted
- 1 May 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.
**Follow-up Control Study for Creativity Study
Purpose: To investigate the effect of transcranial alternating current stimulation (tACS), a form of noninvasive brain stimulation, in healthy subjects. This experiment is a follow-up to previous tACS studies that used a creativity assessment.
Participants: 35 males and females, at least 18 years of age, without history of major psychiatric/neurological disease or associated medication use, or prior brain surgery/implants.
Procedures (methods): This is a cross-over study design. Participants will undergo a control condition of stimulation (sham or individual alpha, 8-12 Hz, tACS) during electroencephalogram recordings. In addition, pupil diameter, heart rate, and respiration will be measured continuously. This is to study the physiological effects of stimulation.
Detailed description
Participants will report for a study visit. They will review and sign a consent form.
They will first be fitted with two 5x7cm electrodes placed over occipital and parietal cortex (Cz and Oz). They will also be fitted with ECG electrodes as well as a respiration belt. In addition, they will have a 128-channel EEG net placed on their head and pupillometry glasses. Once the participant is fitted with this equipment, they will complete a 2-minute resting state EEG with their eyes closed to determine their individual alpha frequency. Following the individual alpha frequency determination, the participant will fill out an alertness questionnaire, followed by 3 EEG recordings:
- 5 minute before stimulation recording
- 20 minute recording during stimulation; either at their individual alpha frequency (between 8 and 12 Hz) or sham stimulation.
- 5 minute after stimulation recording
Following these three recordings, the participant will have a 20 minute break in which they will read neutral reading material or converse with the study staff, as well as provide a saliva sample to test for brain derived neurotropic factor (BDNF).
After the 20 minute break, the participant will complete the alertness questionnaire, and the three recordings will be completed again. The participant will then be allowed to clean up, be paid, and leave.
------------------------
Clarification for the Experimental Design:
This part of the study is a control condition that will consist of stimulation over occipital and parietal cortex with electrodes over Cz and Oz. Participants will then receive 2mA alternating current stimulation between 8Hz and 12Hz (based on their individual alpha frequency determined by a 2 min eyes closed recording) or sham stimulation for 20 minutes (approximately the duration of the TTCT test) in a resting condition where they will have to focus on a cross hair on a computer screen. EEG will be collected simultaneously during this.
In both conditions, the participants wear a Pupil eye tracking headset, which is commercially available. This allows to monitor eye movements and to obtain physiological relevant measures of the pupil.
To obtain a measure of the heart rate during both conditions, ECG electrodes as part of the EEG acquisition system are placed on the participant's body. Ideally one electrode below the left collarbone and a second below the right chest.
Respiration Effort is measured in both conditions by a SleepSense sleep-lab sensor that is placed with an elastic band over the participants chest and connected to the EEG acquisition system.
Before each session, a questionnaire will be administered to the participant to assess the alertness state.
The entire procedure will be conducted by study personnel with documented training using brain stimulators and EEG.
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 stimulation at their individual alpha frequency (8-12 Hz) during a study visit. The order is randomized (i.e., half of participants will receive sham stimulation during the first stimulation session and half will receive sham stimulation during the second stimulation session).
| Arm | Type | Receives |
|---|---|---|
| Sham Stim followed by Alpha Stim | Experimental | Other: NeuroConn Plus Stimulator tACS, Other: NeuroConn Plus Stimulator Sham20 minutes of sham stimulation (sham stim) is followed by a washout period of 20 minutes. 20 minutes of alpha stimulation (alpha stim) is applied next. Sham stimulation mimics the physical effects of stimulation, with up to 1 minute of stimulation during the session. Sham stimulation is delivered using the NeuroConn Plus Stimulator Sham. Participants will receive 2 mA alternating current stimulation at their individual alpha frequency (8-12 Hz, as determined by the 2 minute resting state EEG) for 20 minutes. Alpha stimulation is delivered using the NeuroConn Plus Stimulator tACS. |
| Alpha Stim followed by Sham Stim | Experimental | Other: NeuroConn Plus Stimulator tACS, Other: NeuroConn Plus Stimulator Sham20 minutes of alpha stimulation (alpha stim) is followed by a washout period of 20 minutes. 20 minutes of sham stimulation (sham stim) is applied next. Participants will receive 2 mA alternating current stimulation at their individual alpha frequency (8-12 Hz, as determined by the 2 minute resting state EEG) for 20 minutes. Alpha stimulation is delivered using the NeuroConn Plus Stimulator tACS. Sham stimulation mimics the physical effects of stimulation, with up to 1 minute of stimulation during the session. Sham stimulation is delivered using the NeuroConn Plus Stimulator Sham. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Males and females at least 18 years of age
Key exclusion criteria (9 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 behavior conditions
- First degree relative (parent, sibling, child) with neurological or psychiatric illness (past and present)
- 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 |
|---|---|---|
| NeuroConn Plus Stimulator tACSAlso: tACSTranscranial alternating current stimulation (tACS) is a novel, noninvasive brain stimulation approach in which weak electric currents are applied to the scalp. The electric currents that are applied to the scalp are in a sine-wave pattern. | Other | Alpha Stim followed by Sham Stim, Sham Stim followed by Alpha Stim |
| NeuroConn Plus Stimulator ShamAlso: Sham tACSFor sham stimulation, the participant receives up to 1 minute of tACS stimulation until the stimulation fades. This mimics the same skin sensations that a participant would experience during a tACS session. | Other | Alpha Stim followed by Sham Stim, Sham Stim followed by Alpha Stim |
Primary outcome
Electroencephalogram power in alpha band
Time frame: 5 minute recordings before and after each 20 minute stimulation session during a single study visit.
Changes in the EEG power in the alpha (8-12 Hz) band before and after stimulation sessions.
2 secondary outcomes
Heart Rate Variability
Time frame: 5 minute recordings before and after each 20 minute stimulation session during a single study visit.
Pupil diameter
Time frame: 5 minute recordings before and after each 20 minute stimulation session during a single study visit.
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 19 Aug 2019.
- Individual participant dataSharing planned: Yes. IPD will be shared upon request.
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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
Questions about this trial
What is this clinical trial studying?
A study testing NeuroConn Plus Stimulator tACS in people with Healthy, run by University of North Carolina, Chapel Hill.
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 1 inclusion and 9 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 19 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
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.
What does the primary outcome measure?
Electroencephalogram power in alpha band (time frame: 5 minute recordings before and after each 20 minute stimulation session during a single study visit.). 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 19 Aug 2019.