Self-Administered Transcranial Direct Current Stimulation for Pain in Older Adults With Knee Osteoarthritis
2 other identifiers
interventional
123
1 country
1
Brief Summary
The purpose of this study is to assess the feasibility, acceptability, and efficacy of self-administered transcranial direct current stimulation (tDCS) in older adults with knee osteoarthritis (OA)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Oct 2019
Typical duration for not_applicable
1 active site
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
First Submitted
Initial submission to the registry
July 9, 2019
CompletedFirst Posted
Study publicly available on registry
July 11, 2019
CompletedStudy Start
First participant enrolled
October 18, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 5, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
November 5, 2021
CompletedResults Posted
Study results publicly available
May 10, 2023
CompletedMay 10, 2023
May 1, 2023
2.1 years
July 9, 2019
October 7, 2022
May 8, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Change in Clinical Pain as Assessed by the Numeric Rating Scale (NRS) for Pain
The Numeric Rating Scale (NRS) total score ranges from 0 (no pain) to 100 (most intense pain imaginable).
baseline, week 3
Secondary Outcomes (4)
Change in Pain Related Cortical Response Using a Continuous Wave, Multichannel Functional Near-infrared Spectroscopy (fNIRS) Imaging System
Baseline, week1, week2, and week 3
Acceptability as Measured by the tDCs Experience Questionnaire
week 3
Number of Participants With Possible Side Effects of Treatment
week 3
Feasibility as Assessed by the Number of Participants That Complete the Full tDCS Protocol
week 3
Study Arms (2)
Active tDCS
EXPERIMENTALSham tDCS
PLACEBO COMPARATORInterventions
tDCS with a constant current intensity of 2 mA will be applied for 20 minutes per session daily for 2 weeks (Monday to Friday) via the Soterix 1x1 tDCS mini-CT Stimulator device (Soterix Medical Inc., NY) with headgear and saline-soaked surface sponge electrodes.
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.
Eligibility Criteria
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:
- prosthetic knee replacement or nonarthroscopic surgery to the affected knee
- 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
- current use of sodium channel blockers, calcium channel blockers and NMDS receptor antagonists
- diminished cognitive function that would interfere with understanding study procedures(i.e., Mini-Mental Status Exam score ≤ 23)
- pregnancy or lactation
- hospitalization within the preceding year for psychiatric illness
- no access to a device with internet access that can be used for secure videoconferencing for real-time remote supervision
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The University of Texas Health Science Center at Houston
Houston, Texas, 77030, United States
Related Publications (3)
Lee C, Park J, Kwoh CK, Fain M, Park L, Ahn H. Home-Based, Remotely Supervised Transcranial Direct Current Stimulation Improves the Overall Pain Experience of Older Adults With Knee Osteoarthritis. Pain Res Manag. 2025 Feb 24;2025:1783171. doi: 10.1155/prm/1783171. eCollection 2025.
PMID: 40040747DERIVEDPark J, Tong H, Kang Y, Miao H, Lin L, Fox RS, Telkes I, Martorella G, Ahn H. Comparison of responders and nonresponders with knee osteoarthritis after transcranial direct current stimulation. Pain Manag. 2024 Sep;14(9):507-518. doi: 10.1080/17581869.2024.2429943. Epub 2024 Nov 16.
PMID: 39548963DERIVEDMartorella G, Mathis K, Miao H, Wang D, Park L, Ahn H. Self-administered transcranial direct current stimulation for pain in older adults with knee osteoarthritis: A randomized controlled study. Brain Stimul. 2022 Jul-Aug;15(4):902-909. doi: 10.1016/j.brs.2022.06.003. Epub 2022 Jun 8.
PMID: 35690388DERIVED
Results Point of Contact
- Title
- Dr. Hyochol Ahn
- Organization
- Florida State University
Study Officials
- PRINCIPAL INVESTIGATOR
Hyochol Ahn, PhD, RN, MSN
The University of Texas Health Science Center, Houston
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
- Associate Dean for Research & Professor
Study Record Dates
First Submitted
July 9, 2019
First Posted
July 11, 2019
Study Start
October 18, 2019
Primary Completion
November 5, 2021
Study Completion
November 5, 2021
Last Updated
May 10, 2023
Results First Posted
May 10, 2023
Record last verified: 2023-05
Data Sharing
- IPD Sharing
- Will not share