HealthyNCT02790619
A Pilot Study Investigating Transcranial Direct Current Stimulation (tDCS) to Enhance Mindfulness Meditation
A study testing tDCS via Chattanooga Ionto Iontophoresis System-Phoresor in people with Healthy, run by Medical University of South Carolina.
Trial summary
The purpose of this study is to determine if a new technology applied while listening to a mindfulness meditation tape can affect one's ability to achieve a state of "mindfulness." The new technology is called transcranial direct current stimulation, or tDCS. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- tDCS via Chattanooga Ionto Iontophoresis System-Phoresor
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 15 participants
- Where
- No sites listed yet
- Study dates
- Apr 2015to 21 Mar 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy control volunteers.
- meditation naive
Who cannot join
- Pregnancy,
- History of Mental illness or neurological disorders,
- prior meditative experiences
About this study
The purpose of this study is to determine if a new technology applied while listening to a mindfulness meditation tape can affect one's ability to achieve a state of "mindfulness." The new technology is called transcranial direct current stimulation, or tDCS.
Read the detailed description
Many people initially attempt meditation but cannot get their mind to be still. Or they do not get quick results and find it frustrating. Thus, the number of people benefiting from meditation would increase if there were a method of making it easier to perform. Moreover, establishing the actual brain mechanisms involved in the benefits of meditation would potentially open up synergistic treatments and approaches.
The investigators will investigate the use of a new, non-invasive brain stimulation method called transcranial direct current stimulation (tDCS) to augment a state of mindfulness. tDCS is a safe, inexpensive, non-invasive brain stimulation modality that has the capability of focally increasing or decreasing cortical activity. Anodal stimulation produces positive DC stimulation and is associated with increased cortical activity, whereas Cathodal stimulation produces a negative DC stimulation and is associated with decreased cortical activity. Cortical activity changes occur both during and after stimulation in a dose response fashion (higher current density and longer duration of stimulation produces larger and longer lasting effects).
The investigators will be investigating the use of tDCS to augment mindfulness meditation in a double-blind, crossover, randomized, sham-controlled trial.
- Conditions
- Healthy
- Being tested
- tDCS via Chattanooga Ionto Iontophoresis System-Phoresor, Sham tDCS Chattanooga Ionto Iontophoresis System-Phoresor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tDCS via Chattanooga Ionto Iontophoresis System-PhoresorDevice
Small electrical current delivered non-invasively to the scalp. 1mA electrical current to Meditation and Active Stimulation 1 condition. 2mA to Meditation and Active 2 Stimulation condition.
Sham tDCS Chattanooga Ionto Iontophoresis System-PhoresorDevice
Blinds participants to meditation condition by applying 30 seconds of real stimulation and then turning the device off.
| Study group | Role | What they receive |
|---|---|---|
| Meditation and Active Stimulation 1 | Active comparator | Electrodes will then be placed on the participant and participant will then listen to a meditative recording instructing to focus on participant's breath that will last approximately 5 minutes.Participant will then receive 20 minutes of tDCS with Anode over F8 and cathode over left supraorbital area with 1 milliamp(mA) stimulation with intervention administration delivered by tDCS via Chattanooga Ionto Iontophoresis System-Phoresor. Receives: Device: tDCS via Chattanooga Ionto Iontophoresis System-Phoresor |
| Meditation and Active Stimulation 2 | Active comparator | Electrodes will then be placed on the participant and participant will then listen to a meditative recording instructing to focus on participant's breath that will last approximately 5 minutes.Participant will then receive 20 minutes of tDCS with Anode over F8 and cathode over left supraorbital area with 2 mA stimulation with intervention administration delivered by tDCS via Chattanooga Ionto Iontophoresis System-Phoresor. Receives: Device: tDCS via Chattanooga Ionto Iontophoresis System-Phoresor |
| Meditation and Sham Stimulation | Sham comparator | Electrodes will then be placed on the participant and participant will then listen to a meditative recording instructing to focus on participant's breath that will last approximately 5 minutes.The participants in the sham study will receive Sham tDCS (no stimulation) with Anode over F8 and cathode over left supraorbital area with intervention administration delivered by Sham tDCS Chattanooga Ionto Iontophoresis System-Phoresor Receives: Device: Sham tDCS Chattanooga Ionto Iontophoresis System-Phoresor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline Mood Visual Analog Scale (Mood VAS) at Post Stimulation of Experimental Visit One
During Experimental Visit 1 the participant will complete the Mood Visual Analog Scale before listening to a meditative tape recording and receiving either active tDCS or sham tDCS for 20 minutes. The participant will then fill out the Mood Visual Analog Scale post stimulation.
Measured: Baseline (Visit 1/Week 1) Post Stimulation (Visit 1/Week 1). Through Visit 1 completion, an average of 25 minutes
Change from Baseline Mood Visual Analog Scale (Mood VAS) at Post Stimulation of Experimental Visit Two
During Experimental Visit 2 the participant will complete the Mood Visual Analog Scale before listening to a meditative tape recording and receiving either active tDCS or sham tDCS for 20 minutes. The participant will then fill out the Mood Visual Analog Scale post stimulation.
Measured: Baseline (Visit 2/Week 2) Post Stimulation (Visit 2/Week 2). Through Visit 2 completion, an average of 25 minutes
Change from Baseline Mood Visual Analog Scale (Mood VAS) at Post Stimulation of Experimental Visit Three
During Experimental Visit 3 the participant will complete the Mood Visual Analog Scale before listening to a meditative tape recording and receiving either active tDCS or sham tDCS for 20 minutes. The participant will then fill out the Mood Visual Analog Scale post stimulation.
Measured: Baseline (Visit 3/Week 3) Post Stimulation (Visit 3/Week 3). Through Visit 3 completion, an average of 25 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2016 (estimated)
- Study startApr 2015
- Primary completionAug 2015
- Study completion21 Mar 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 Medical University of South CarolinaThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02790619
- Sponsor's protocol ID
- Pro00042149
- Status last verified
- Jul 2018
- First submitted
- 13 Jul 2015
- Last updated
- 2 Aug 2018
- 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 2 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study Investigating Transcranial Direct Current Stimulation (tDCS) to Enhance Mindfulness Meditation
- ClinicalTrials.gov ID
- NCT02790619
- Acronym / sponsor ID
- Pro00042149
- Conditions
- Healthy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Study start
- Apr 2015
- Primary completion
- Aug 2015 (actual)
- Study completion
- 21 Mar 2017 (actual)
- First posted
- 6 Jun 2016 (estimated)
- 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 determine if a new technology applied while listening to a mindfulness meditation tape can affect one's ability to achieve a state of "mindfulness." The new technology is called transcranial direct current stimulation, or tDCS.
Detailed description
Many people initially attempt meditation but cannot get their mind to be still. Or they do not get quick results and find it frustrating. Thus, the number of people benefiting from meditation would increase if there were a method of making it easier to perform. Moreover, establishing the actual brain mechanisms involved in the benefits of meditation would potentially open up synergistic treatments and approaches.
The investigators will investigate the use of a new, non-invasive brain stimulation method called transcranial direct current stimulation (tDCS) to augment a state of mindfulness. tDCS is a safe, inexpensive, non-invasive brain stimulation modality that has the capability of focally increasing or decreasing cortical activity. Anodal stimulation produces positive DC stimulation and is associated with increased cortical activity, whereas Cathodal stimulation produces a negative DC stimulation and is associated with decreased cortical activity. Cortical activity changes occur both during and after stimulation in a dose response fashion (higher current density and longer duration of stimulation produces larger and longer lasting effects).
The investigators will be investigating the use of tDCS to augment mindfulness meditation in a double-blind, crossover, randomized, sham-controlled trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Meditation and Active Stimulation 1 | Active comparator | Device: tDCS via Chattanooga Ionto Iontophoresis System-PhoresorElectrodes will then be placed on the participant and participant will then listen to a meditative recording instructing to focus on participant's breath that will last approximately 5 minutes.Participant will then receive 20 minutes of tDCS with Anode over F8 and cathode over left supraorbital area with 1 milliamp(mA) stimulation with intervention administration delivered by tDCS via Chattanooga Ionto Iontophoresis System-Phoresor. |
| Meditation and Active Stimulation 2 | Active comparator | Device: tDCS via Chattanooga Ionto Iontophoresis System-PhoresorElectrodes will then be placed on the participant and participant will then listen to a meditative recording instructing to focus on participant's breath that will last approximately 5 minutes.Participant will then receive 20 minutes of tDCS with Anode over F8 and cathode over left supraorbital area with 2 mA stimulation with intervention administration delivered by tDCS via Chattanooga Ionto Iontophoresis System-Phoresor. |
| Meditation and Sham Stimulation | Sham comparator | Device: Sham tDCS Chattanooga Ionto Iontophoresis System-PhoresorElectrodes will then be placed on the participant and participant will then listen to a meditative recording instructing to focus on participant's breath that will last approximately 5 minutes.The participants in the sham study will receive Sham tDCS (no stimulation) with Anode over F8 and cathode over left supraorbital area with intervention administration delivered by Sham tDCS Chattanooga Ionto Iontophoresis System-Phoresor |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Healthy control volunteers.
- meditation naive
Key exclusion criteria (3 listed)
- Pregnancy,
- History of Mental illness or neurological disorders,
- prior meditative experiences
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 |
|---|---|---|
| tDCS via Chattanooga Ionto Iontophoresis System-PhoresorSmall electrical current delivered non-invasively to the scalp. 1mA electrical current to Meditation and Active Stimulation 1 condition. 2mA to Meditation and Active 2 Stimulation condition. | Device | Meditation and Active Stimulation 1, Meditation and Active Stimulation 2 |
| Sham tDCS Chattanooga Ionto Iontophoresis System-PhoresorBlinds participants to meditation condition by applying 30 seconds of real stimulation and then turning the device off. | Device | Meditation and Sham Stimulation |
Primary outcome
Change from Baseline Mood Visual Analog Scale (Mood VAS) at Post Stimulation of Experimental Visit One
Time frame: Baseline (Visit 1/Week 1) Post Stimulation (Visit 1/Week 1). Through Visit 1 completion, an average of 25 minutes
During Experimental Visit 1 the participant will complete the Mood Visual Analog Scale before listening to a meditative tape recording and receiving either active tDCS or sham tDCS for 20 minutes. The participant will then fill out the Mood Visual Analog Scale post stimulation.
Change from Baseline Mood Visual Analog Scale (Mood VAS) at Post Stimulation of Experimental Visit Two
Time frame: Baseline (Visit 2/Week 2) Post Stimulation (Visit 2/Week 2). Through Visit 2 completion, an average of 25 minutes
During Experimental Visit 2 the participant will complete the Mood Visual Analog Scale before listening to a meditative tape recording and receiving either active tDCS or sham tDCS for 20 minutes. The participant will then fill out the Mood Visual Analog Scale post stimulation.
Change from Baseline Mood Visual Analog Scale (Mood VAS) at Post Stimulation of Experimental Visit Three
Time frame: Baseline (Visit 3/Week 3) Post Stimulation (Visit 3/Week 3). Through Visit 3 completion, an average of 25 minutes
During Experimental Visit 3 the participant will complete the Mood Visual Analog Scale before listening to a meditative tape recording and receiving either active tDCS or sham tDCS for 20 minutes. The participant will then fill out the Mood Visual Analog Scale post 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 2 Aug 2018.
Related trials for Healthy
RecruitingObservational study
Survey to Determine Incarcerated Persons' Views on Surrogate Decision Making
Healthy Volunteers
Recruiting
Effects of Urolithin A Supplementation on Glucose Metabolism in Healthy Adults 55 >= Years Old: A Randomized Triple-Masked Controlled Clinical Trial
Healthy Volunteer
Active, not recruitingPhase 3
A Clinical Study to Evaluate the Safety, Tolerability, and Immunogenicity of VAX-31 With Influenza Vaccine in Adults ≥ 50 Years of Age
Pneumococcal Disease
Recruiting
Effect of a Fermented Dairy Protein With Prebiotic Fiber on GI Complaints
Digestive Health, Quality of Life
Not yet recruitingPhase 1
Dynamic Magnetic Resonance Imaging of Human Subarachnoid Space Using Intrathecal Gadolinium Contrast
Healthy Volunteers
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing tDCS via Chattanooga Ionto Iontophoresis System-Phoresor in people with Healthy, run by Medical University of South Carolina.
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 3 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 2 Aug 2018. 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. 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?
Change from Baseline Mood Visual Analog Scale (Mood VAS) at Post Stimulation of Experimental Visit One (time frame: Baseline (Visit 1/Week 1) Post Stimulation (Visit 1/Week 1). Through Visit 1 completion, an average of 25 minutes). The study lists 3 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 2 Aug 2018.