A Pilot Study Investigating Transcranial Direct Current Stimulation (tDCS) to Enhance Mindfulness Meditation

Not Applicable

Completed

• Conditions: Healthy
• Interventions: Device: tDCS via Chattanooga Ionto Iontophoresis System-Phoresor; Device: Sham tDCS Chattanooga Ionto Iontophoresis System-Phoresor

• Registration Number: NCT02790619
• Lead Sponsor: Medical University of South Carolina

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.

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.

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study Start: 2015-04
• Study First Submitted: 2015-07-13
• Primary Completion: 2015-08
• Study First Submitted QC: 2016-05-31
• Study First Posted: 2016-06-06
• Study Completion: 2017-03-21
• Status Verified: 2018-07
• Last Update Submitted: 2018-07-31
• Last Update Posted: 2018-08-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

• Healthy control volunteers.
• meditation naive

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Exclusion Criteria

• Pregnancy,
• History of Mental illness or neurological disorders,
• prior meditative experiences

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Meditation and Active Stimulation 1	tDCS via Chattanooga Ionto Iontophoresis System-Phoresor	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.
Meditation and Sham Stimulation	Sham tDCS Chattanooga Ionto Iontophoresis System-Phoresor	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
Meditation and Active Stimulation 2	tDCS via Chattanooga Ionto Iontophoresis System-Phoresor	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.

Primary Outcome Measures

Name	Time	Method
Change from Baseline Mood Visual Analog Scale (Mood VAS) at Post Stimulation of Experimental Visit One	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	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	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.