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

NCT04375072 | Completed Results FDA Device

• 3 other identifiers: STUDY00003164R01NR019051R01NR019051-03S1
• Study Type: interventional
• Target: 208
• Locations: 1 country
• Sites: 1

Brief Summary

This clinical trial aims to evaluate whether a 2 week regimen of transcranial direct current stimulation (tDCS) paired with mindfulness-based meditation (MBM) can improve pain modulation, reduce clinical pain, and alleviate osteoarthritis (OA)-related symptoms in patients with knee OA.

Conditions

Osteo Arthritis Knee

Keywords

meditation

Outcome Measures

Primary Outcomes (1)

• Change in Numeric Rating Score (NRS) of Pain

  The Numeric Rating Scale (NRS) is a subjective measure of pain intensity. The NRS total score ranges from 0 (no pain) to 100 (most intense pain imaginable). Change in NRS = Week 2 (post-intervention) NRS - Baseline (pre-intervention) NRS. A decrease in NRS score indicates improvement.

  baseline, week 2 (after 10 tDCS sessions)

Secondary Outcomes (1)

• Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC).

  baseline, week 2 (after 10 tDCS sessions)

Study Arms (4)

active tDCS paired with active MBM,

EXPERIMENTAL

Device: active tDCS paired with active MBM

sham tDCS paired with active MBM

ACTIVE COMPARATOR

Device: sham tDCS paired with active MBM

active tDCS paired with sham MBM

ACTIVE COMPARATOR

Device: active tDCS paired with sham MBM

sham tDCS paired with sham MBM

SHAM COMPARATOR

Device: sham tDCS paired with sham MBM

Interventions

active tDCS paired with active MBM DEVICE

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.

active tDCS paired with active MBM,

sham tDCS paired with active MBM DEVICE

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 during each 20-minute session, conducted daily for 2 weeks. The meditation intervention will be applied simultaneously with tDCS for 20 minutes per session daily for 2 weeks by a recorded meditation.

sham tDCS paired with active MBM

active tDCS paired with sham MBM DEVICE

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 sham MBM intervention will be delivered via a CD player that will look identical in both active and sham MBM.

active tDCS paired with sham MBM

sham tDCS paired with sham MBM DEVICE

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 during each 20-minute session, conducted daily for 2 weeks. The sham MBM intervention will be delivered via a CD player that will look identical in both active and sham MBM.

sham tDCS paired with sham MBM

Eligibility Criteria

• Age: 50 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Arizona: lead
• National Institute of Nursing Research (NINR): collaborator

Study Sites (1)

University of Arizona

Tucson, Arizona, 85721, United States

Location

Results Point of Contact

• Title: Hyochol Brian Ahn
• Organization: The University of Arizona

hbrian@arizona.edu

520.626.1769

Study Officials

• Hyochol Ahn, PhD,RN,MSN

  University of Arizona

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dean & Professor

Study Record Dates

• First Submitted: April 30, 2020
• First Posted: May 5, 2020
• Study Start: August 13, 2020
• Primary Completion: January 30, 2025
• Study Completion: January 30, 2025
• Last Updated: November 12, 2025
• Results First Posted: November 12, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)