Self-Administered Transcranial Direct Current Stimulation for Pain in Older Adults With Knee Osteoarthritis

Study Overview
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Brief Summary
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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)

Official Title
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Self-Administered Transcranial Direct Current Stimulation for Pain in Older Adults With Knee Osteoarthritis: A Phase II Randomized Sham-Controlled Trial

Conditions
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Osteo Arthritis Knee

Intervention / Treatment
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* Device: Active tDCS
* Device: Sham tDCS


Participation Criteria
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Eligibility Criteria
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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: 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

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Active tDCS<br> | Device: Active tDCS<br>* 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.<br>* Other names: Soterix 1x1 tDCS mini-CT Stimulator;|
| Placebo Comparator: Sham tDCS<br> | Device: Sham tDCS<br>* 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.<br>* Other names: Soterix 1x1 tDCS mini-CT Stimulator;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Pain Related Cortical Response Using a Continuous Wave, Multichannel Functional Near-infrared Spectroscopy (fNIRS) Imaging System | Pain-related cortical response will be measured using a continuous-wave, multichannel fNIRS imaging system (LIGHTNIRS, Shimadzu, Kyoto, Japan) with three semiconductor lasers at 780, 805, and 830 nm. Optical recordings will be collected during thermal and punctate pain stimulation and correlation values will be presented in the form of figures. Specify the full scale: Pearson correlation coefficient (r) between pairs of brain regions (fNIRS channels). A value of r=0 indicates that two brain regions were functionally disconnected. Greater absolute r values denote stronger connections. However, this does not indicate a better or worse result but only a different type of connectivity on a macroscale (when considering several fNIRS channels). We used |r|>0.3 (absolute value of r greater than 0.3) to extract meaningful functional connections. | Baseline, week1, week2, and week 3 | 
| Acceptability as Measured by the tDCs Experience Questionnaire | The tDCS experience questionnaire contains 10 questions based on a scale from 0-10, 0 being strongly disagree and 10 being strongly agree. Higher scores indicating greater acceptability for 7 questions and lower scores indicating greater acceptability for 3 questions resulting most desirable score of a 70. | week 3 | 
| Number of Participants With Possible Side Effects of Treatment | If any side effects are reported, the degree of relatedness to the intervention will be assessed on a 10-point scale, from 0 (not at all) to 10 (to a high degree). The questionnaire ask to what extend did the participant experienced symptoms like, tingling, itching sensation, burning sensation, pain at the stimulation site, fatigue, nervousness, headache, difficulty concentrating, or mood change. | week 3 | 
| Feasibility as Assessed by the Number of Participants That Complete the Full tDCS Protocol | We will calculate the percentage of participants who a) meet the inclusion criteria, b) agree to be randomly assigned, c) complete the full tDCS protocol, and d) attend the follow-up assessment. | week 3 |