Study Summary
This trial will test whether mindfulness meditation and transcranial direct current stimulation (tDCS) can reduce pain for people with knee osteoarthritis, especially among African Americans and non-Hispanic whites.
Eligible Conditions
- Osteoarthritis of the Knee
Treatment Effectiveness
Study Objectives
1 Primary · 0 Secondary · Reporting Duration: Baseline; Day 1; Day 2; Day 3; Day 4; Day 5
Day 5
Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC).
Trial Safety
Safety Progress
Side Effects for
tDCS + Robotic Arm Therapy
3%back pain flair up
3%Myasthenia Gravis
Trial Design
2 Treatment Groups
Non-Hispanic White Group
1 of 2
African American Group
1 of 2
Experimental Treatment
240 Total Participants · 2 Treatment Groups
Primary Treatment: Transcranial Direct Current Stimulation (tDCS) · No Placebo Group · N/A
Non-Hispanic White GroupExperimental Group · 4 Interventions: Standard Breathing and Attention Training (BAT), Transcranial Direct Current Stimulation (tDCS), Sham Transcranial Direct Current Stimulation (tDCS), Focused Breathing and Attention Training (BAT) · Intervention Types: Behavioral, Device, Device, Behavioral
African American GroupExperimental Group · 4 Interventions: Standard Breathing and Attention Training (BAT), Transcranial Direct Current Stimulation (tDCS), Sham Transcranial Direct Current Stimulation (tDCS), Focused Breathing and Attention Training (BAT) · Intervention Types: Behavioral, Device, Device, Behavioral
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Transcranial Direct Current Stimulation (tDCS)
2016
Completed Phase 2
~1650
Sham Transcranial Direct Current Stimulation (tDCS)
2021
N/A
~180
Trial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: baseline; day 1; day 2; day 3; day 4; day 5
Who is running the clinical trial?
National Institute on Aging (NIA)NIH
1,417 Previous Clinical Trials
3,486,315 Total Patients Enrolled
10 Trials studying Osteoarthritis of the Knee
6,359 Patients Enrolled for Osteoarthritis of the Knee
University of FloridaLead Sponsor
1,251 Previous Clinical Trials
698,573 Total Patients Enrolled
7 Trials studying Osteoarthritis of the Knee
678 Patients Enrolled for Osteoarthritis of the Knee
Roger FillingimPrincipal InvestigatorUniversity of Florida
Eligibility Criteria
Age 45 - 85 · All Participants · 2 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:You have symptoms of knee OA in one or both knees.
You are of African American or non-Hispanic white ethnicity.
Who else is applying?
What state do they live in?
| Alabama | 100.0% |
What site did they apply to?
| University of Alabama at Birmingham | 100.0% |
What portion of applicants met pre-screening criteria?
| Met criteria | 100.0% |
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Conditions
Cancer Related
Treatments