A Pilot Study Investigating Transcranial Direct Current Stimulation (tDCS) to Enhance Mindfulness Meditation
1 other identifier
interventional
15
0 countries
N/A
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable healthy
Started Apr 2015
Typical duration for not_applicable healthy
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2015
CompletedFirst Submitted
Initial submission to the registry
July 13, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2015
CompletedFirst Posted
Study publicly available on registry
June 6, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
March 21, 2017
CompletedAugust 2, 2018
July 1, 2018
4 months
July 13, 2015
July 31, 2018
Conditions
Outcome Measures
Primary Outcomes (3)
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.
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.
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.
Baseline (Visit 3/Week 3) Post Stimulation (Visit 3/Week 3). Through Visit 3 completion, an average of 25 minutes
Study Arms (3)
Meditation and Active Stimulation 1
ACTIVE COMPARATORElectrodes 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 COMPARATORElectrodes 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 COMPARATORElectrodes 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
Interventions
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.
Blinds participants to meditation condition by applying 30 seconds of real stimulation and then turning the device off.
Eligibility Criteria
You may qualify if:
- Healthy control volunteers.
- meditation naive
You may not qualify if:
- Pregnancy,
- History of Mental illness or neurological disorders,
- prior meditative experiences
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 13, 2015
First Posted
June 6, 2016
Study Start
April 1, 2015
Primary Completion
August 1, 2015
Study Completion
March 21, 2017
Last Updated
August 2, 2018
Record last verified: 2018-07