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

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Florida State University

Status

Completed

Conditions

Osteo Arthritis Knee

Treatments

Device: Sham tDCS
Device: Active tDCS

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT04016272
HSC-SN-19-0469
R15NR018050 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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)

Enrollment

123 patients

Sex

All

Ages

50 to 85 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

123 participants in 2 patient groups, including a placebo group

Active tDCS
Experimental group
Treatment:
Device: Active tDCS
Sham tDCS
Placebo Comparator group
Treatment:
Device: Sham tDCS

Trial documents
1

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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