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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

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ClinicalTrials.gov Identifier: NCT04016272
Recruitment Status : Not yet recruiting
First Posted : July 11, 2019
Last Update Posted : July 11, 2019
Sponsor:
Collaborator:
National Institute of Nursing Research (NINR)
Information provided by (Responsible Party):
Hyochol Ahn, The University of Texas Health Science Center, Houston

Brief Summary:
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)

Condition or disease Intervention/treatment Phase
Osteo Arthritis Knee Device: Active tDCS Device: Sham tDCS Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Self-Administered Transcranial Direct Current Stimulation for Pain in Older Adults With Knee Osteoarthritis: A Phase II Randomized Sham-Controlled Trial
Estimated Study Start Date : August 1, 2019
Estimated Primary Completion Date : July 31, 2022
Estimated Study Completion Date : July 31, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

Arm Intervention/treatment
Experimental: Active tDCS Device: Active tDCS
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.
Other Name: Soterix 1x1 tDCS mini-CT Stimulator

Placebo Comparator: Sham tDCS Device: Sham tDCS
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.
Other Name: Soterix 1x1 tDCS mini-CT Stimulator




Primary Outcome Measures :
  1. Change in clinical pain as assessed by the numeric rating scale (NRS) for pain [ Time Frame: baseline, week 3 ]
    The NRS total score ranges from 0 (no pain) to 100 (most intense pain imaginable).


Secondary Outcome Measures :
  1. Change in pain related cortical response using a continuous wave, multichannel Functional near-infrared spectroscopy (fNIRS) imaging system [ Time Frame: Baseline, week 3 ]
    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 pain stimulation.

  2. Acceptability as measured by the tDCs experience questionnaire [ Time Frame: week 3 ]
    The questionnaire is based on scale from 0-10, 0 being strongly disagree and 10 being strongly agree for a total maximum score of a 100, with higher scores indicating greater acceptibility.

  3. Number of participants with possible side effects of treatment [ Time Frame: week 3 ]
  4. Feasibility as assessed by the number of participants that complete the full tDCS protocol [ Time Frame: week 3 ]


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Ages Eligible for Study:   50 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04016272


Contacts
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Contact: Hyochol Ahn, PhD, RN, MSN (713) 500-2179 Hyochol.Ahn@uth.tmc.edu

Locations
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United States, Texas
The University of Texas Health Science Center at Houston Not yet recruiting
Houston, Texas, United States, 77030
Sponsors and Collaborators
The University of Texas Health Science Center, Houston
National Institute of Nursing Research (NINR)
Investigators
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Principal Investigator: Hyochol Ahn, PhD, RN, MSN The University of Texas Health Science Center, Houston

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Responsible Party: Hyochol Ahn, Associate Professor, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier: NCT04016272     History of Changes
Other Study ID Numbers: HSC-SN-19-0469
First Posted: July 11, 2019    Key Record Dates
Last Update Posted: July 11, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
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Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases