Print

Purpose

The purpose of this study is to determine the feasibility and preliminary efficacy of two weeks of self Transcranial Direct Current Stimulation (tDCS) for pain in older patients with knee osteoarthritis (OA).

Conditions

Eligibility

Eligible Ages
Between 50 Years and 80 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • have self-reported unilateral or bilateral knee OA pain, according to American College of Rheumatology criteria - have had knee OA pain in the past 3 months with an average of at least 3 on a 10 cm Visual Analog Scale (VAS) for pain - can speak and read English - have a device with internet access that can be used for secure video conferencing for real-time remote supervision - have access to a distraction-free, well lit, clean environment with a safe area to store the device and device kit - have no plan to change medication regimens for pain throughout the trial - are able to travel to the coordinating center - are willing and able to provide written informed consent prior to enrollment.

Exclusion Criteria

  • previous prosthetic knee replacement or non-arthroscopic surgery to the affected knee - history of brain surgery, tumor, seizure, stroke, or intracranial metal implantation - systemic rheumatic disorders, including rheumatoid arthritis, systemic lupus erythematosus, and fibromyalgia - uncontrolled hypertension (i.e., systolic blood pressure/ diastolic blood pressure ≥ 150/95 mm Hg) - heart failure - history of acute myocardial infarction - peripheral neuropathy - alcohol/substance abuse - cognitive impairment (i.e., Mini-Mental Status Exam score ≤ 23) - pregnancy or lactation - hospitalization within the preceding year for psychiatric illness

Study Design

Phase
N/A
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Transcranial Direct Current Stimulation 		Transcranial Direct Current Stimulation (tDCS) involves the application of weak direct electric current to the head in a noninvasive and painless manner. tDCS with a constant current intensity of 2 milliamps (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. Participants will self-administer tDCS at their home or a private room for two weeks (Mondays-Fridays) under real-time supervision by the research staff.
  • Device: Soterix 1x1 tDCS mini-CT Stimulator device
    Transcranial Direct Current Stimulation (tDCS) involves the application of weak direct electric current to the head in a noninvasive and painless manner. 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. Participants will self-administer tDCS at their home or a private room for two weeks (Mondays-Fridays) under real-time supervision by the research staff.

More Details

Status
Completed
Sponsor
The University of Texas Health Science Center, Houston

Study Contact

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.