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Mindfulness + tDCS for Osteoarthritis (PROACT Trial)

N/A
Recruiting
Led By Roger Fillingim
Research Sponsored by University of Florida
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Unilateral or bilateral symptomatic knee OA based on American College of Rheumatology Clinical criteria
Be older than 18 years old
Must not have
Actively symptomatic systemic rheumatic disease/condition (e.g. rheumatoid arthritis, systemic lupus erythematosus), or fibromyalgia that results in pain outside the knee that is equal to or worse than the participant's knee pain
Neurological disease (e.g. Parkinson's, multiple sclerosis, epilepsy) or evidence of previous brain injury, including stroke and traumatic brain injury
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline; day 1; day 2; day 3; day 4; day 5
Awards & highlights
No Placebo-Only Group

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.

Who is the study for?
This trial is for African American or non-Hispanic white adults with knee osteoarthritis, as per the American College of Rheumatology criteria. Excluded are those with significant knee surgery history, uncontrolled hypertension, substance use disorders, daily opioid use, serious psychiatric conditions in the past year, other painful rheumatic diseases or fibromyalgia, and certain neurological conditions.
What is being tested?
The PROACT study tests if mindfulness meditation training (MMT), Transcranial Direct Current Stimulation (tDCS), their combination or a sham procedure can improve pain management and brain function related to pain in people with knee osteoarthritis over five days.
What are the potential side effects?
Potential side effects from tDCS may include mild tingling, itching or discomfort at the electrode site on the scalp during stimulation. Mindfulness meditation is generally considered safe but could potentially cause emotional discomfort when dealing with thoughts and sensations.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have knee pain diagnosed as osteoarthritis by a doctor.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have a condition like rheumatoid arthritis or lupus causing pain not less than my knee pain.
Select...
I have a neurological condition like Parkinson's, MS, epilepsy, or have had a brain injury.
Select...
I do not have high blood pressure or heart problems that limit my activities.
Select...
My cognitive function is good enough to understand the study procedures.
Select...
I have had major surgery on my knee.
Select...
I do not use opioids daily.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline; day 1; day 2; day 3; day 4; day 5
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline; day 1; day 2; day 3; day 4; day 5 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC).

Side effects data

From 2018 Phase 2 trial • 54 Patients • NCT01726673
3%
back pain flair up
3%
Myasthenia Gravis
100%
80%
60%
40%
20%
0%
Study treatment Arm
tDCS + Robotic Arm Therapy
tDCS Sham + Robotic Arm Therapy

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Group I: Non-Hispanic White GroupExperimental Treatment4 Interventions
Non-Hispanic whites with knee osteoarthritis (OA).
Group II: African American GroupExperimental Treatment4 Interventions
African Americans with knee osteoarthritis (OA).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Sham Transcranial Direct Current Stimulation (tDCS)
2021
N/A
~200
Transcranial Direct Current Stimulation (tDCS)
2016
Completed Phase 2
~2150

Find a Location

Who is running the clinical trial?

National Institute on Aging (NIA)NIH
1,789 Previous Clinical Trials
28,188,092 Total Patients Enrolled
University of FloridaLead Sponsor
1,402 Previous Clinical Trials
764,526 Total Patients Enrolled
Roger FillingimPrincipal InvestigatorUniversity of Florida

Media Library

Standard Breathing and Attention Training (BAT) Clinical Trial Eligibility Overview. Trial Name: NCT03884374 — N/A
Knee Arthritis Research Study Groups: Non-Hispanic White Group, African American Group
Knee Arthritis Clinical Trial 2023: Standard Breathing and Attention Training (BAT) Highlights & Side Effects. Trial Name: NCT03884374 — N/A
Standard Breathing and Attention Training (BAT) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03884374 — N/A
~12 spots leftby Feb 2025
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