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Home-based tDCS and Mindfulness-based Meditation for Self-management of Clinical Pain and Symptoms

Study Purpose

The purpose of this study is to determine the effects of active transcranial direct current stimulation (tDCS) paired with active mindfulness-based meditation (MBM) on clinical pain,osteo arthritis (OA)-related clinical symptoms, physiopsychological pain processing and participant satisfaction with treatment in patients with knee OA.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Interventional
Eligible Ages 50 Years - 85 Years
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - have symptomatic knee OA based on American College of Rheumatology clinical criteria.
  • - have had knee OA pain in the past 3 months with an average of at least 30 on a 0-100 NRS for pain, - can speak and read English.
  • - have no plan to change medication regimens for pain throughout the trial.

Exclusion Criteria:

  • - history of brain surgery, brain tumor, seizure, stroke, or intracranial metal implantation.
  • - systemic rheumatic disorders, including rheumatoid arthritis,systemic lupus erythematosus, and fibromyalgia.
  • - alcohol/substance abuse.
  • - diminished cognitive function that would interfere with understanding study procedures (i.e., Mini-Mental Status Exam score ≤ 23) - pregnancy or lactation.
  • - prosthetic knee replacement or non-arthroscopic surgery to the affected knee.
  • - hospitalization within the preceding year for psychiatric illness.
  • - no access to a device that can be used for secure videoconferencing for real-time remote supervision.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT04375072
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

 N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 University of Arizona
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 Hyochol Ahn, PhD,RN,MSN
Principal Investigator Affiliation University of Arizona
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Other, NIH
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Osteo Arthritis Knee
Arms & Interventions

Arms

Experimental: active tDCS paired with active MBM,

Active Comparator: sham tDCS paired with active MBM

Active Comparator: active tDCS paired with sham MBM

Sham Comparator: sham tDCS paired with sham MBM

Interventions

Device: - active tDCS paired with active MBM

Active tDCS with a constant current intensity of 2 milli ampere( mA)will be applied for 20 minutes per session daily for 2 weeks via the Soterix 1x1 tDCS mini-CT Stimulator device with headgear and saline-soaked surface sponge electrodes. The meditation intervention will be applied simultaneously with tDCS for 20 minutes per session daily for 2 weeks by a recorded meditation.

Device: - sham tDCS paired with active MBM

For sham stimulation, the electrodes will be placed in the same positions as for active stimulation, but the stimulator will only deliver 2(milli ampere) mA current for 30 seconds. The meditation intervention will be applied simultaneously with tDCS for 20 minutes per session daily for 2 weeks by a recorded meditation.

Device: - active tDCS paired with sham MBM

Active tDCS with a constant current intensity of 2 mA will be applied for 20 minutes per session daily for 2 weeks via the Soterix 1x1 tDCS mini-CT Stimulator device with headgear and saline-soaked surface sponge electrodes. The sham MBM intervention will be delivered via a CD player that will look identical in both active and sham MBM.

Device: - sham tDCS paired with sham MBM

For sham stimulation, the electrodes will be placed in the same positions as for active stimulation, but the stimulator will only deliver 2 mA current for 30 seconds. The sham MBM intervention will be delivered via a CD player that will look identical in both active and sham MBM.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

University of Arizona, Tucson, Arizona

Status

Recruiting

Address

University of Arizona

Tucson, Arizona, 85721

Site Contact

Hyochol Ahn, PhD,RN,MSN

[email protected]

520-626-1769

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