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

NCT03425019 | Completed Results FDA Device

• 1 other identifier: HSC-SN-17-1072
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief Summary

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

Knee Osteoarthritis; Chronic Pain

Keywords

Knee Osteoarthritis; Chronic Pain; Osteoarthritis; Transcranial Direct Current Stimulation; tDCS

Outcome Measures

Primary Outcomes (2)

• Clinical Pain Intensity as Assessed by a Visual Analogue Scale (VAS)

  Scores on the visual analogue scale (VAS) range from 0 (no pain) to 100 (worst pain imaginable).

  baseline

• Clinical Pain Intensity as Assessed by a Visual Analogue Scale (VAS)

  Scores on the visual analogue scale (VAS) range from 0 (no pain) to 100 (worst pain imaginable).

  2 weeks

Secondary Outcomes (35)

• Clinical Pain Intensity as Assessed by the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) - Pain Subscale

  baseline

• Clinical Pain Intensity as Assessed by the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) - Pain Subscale

  2 weeks

• Clinical Pain Intensity as Assessed by the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) - Stiffness Subscale

  baseline

• Clinical Pain Intensity as Assessed by the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) - Stiffness Subscale

  2 weeks

• Clinical Pain Intensity as Assessed by the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) - Functional Impairment Subscale

  baseline

Study Arms (1)

Transcranial Direct Current Stimulation

EXPERIMENTAL

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

Interventions

Soterix 1x1 tDCS mini-CT Stimulator device 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.

Transcranial Direct Current Stimulation

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead

Study Sites (1)

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

Location

Related Publications (1)

• Ahn H, Sorkpor S, Miao H, Zhong C, Jorge R, Park L, Abdi S, Cho RY. Home-based self-administered transcranial direct current stimulation in older adults with knee osteoarthritis pain: An open-label study. J Clin Neurosci. 2019 Aug;66:61-65. doi: 10.1016/j.jocn.2019.05.023. Epub 2019 May 29.

  PMID: 31153751 RESULT

MeSH Terms

Conditions

Osteoarthritis, Knee; Chronic Pain; Osteoarthritis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Hyochol Ahn
• Organization: The University of Texas Health Science Center at Houston

hahn@fsu.edu

(713) 500-2179

Study Officials

• Hyochol Ahn, PhD

  The University of Texas Health Science Center, Houston

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: January 30, 2018
• First Posted: February 7, 2018
• Study Start: March 14, 2018
• Primary Completion: October 5, 2018
• Study Completion: October 5, 2018
• Last Updated: October 15, 2021
• Results First Posted: October 15, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)