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

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02790619
• Other study ID #: Pro00042149
• Status: Completed
• Phase: N/A
• Start date: April 2015
• Est. completion date: March 21, 2017

Study information

• Verified date: July 2018
• Source: Medical University of South Carolina
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: March 21, 2017
• Est. primary completion date: August 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• Healthy control volunteers.

• meditation naive

Exclusion Criteria:

• Pregnancy,

• History of Mental illness or neurological disorders,

• prior meditative experiences

Related Conditions & MeSH terms

• Healthy

Intervention

Device:
• tDCS via Chattanooga Ionto Iontophoresis System-Phoresor
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-Phoresor
Blinds participants to meditation condition by applying 30 seconds of real stimulation and then turning the device off.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of South Carolina

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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