Self Transcranial Direct Current Stimulation for Pain in Older Adults With Knee Osteoarthritis
NCT ID: NCT03425019
Last Updated: 2021-10-15
Study Results
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View full resultsBasic Information
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COMPLETED
NA
21 participants
INTERVENTIONAL
2018-03-14
2018-10-05
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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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.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion 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
* 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
50 Years
80 Years
ALL
No
Sponsors
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The University of Texas Health Science Center, Houston
OTHER
Responsible Party
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Hyochol Ahn
Associate Professor
Principal Investigators
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Hyochol Ahn, PhD
Role: PRINCIPAL_INVESTIGATOR
The University of Texas Health Science Center, Houston
Locations
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The University of Texas Health Science Center at Houston
Houston, Texas, United States
Countries
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References
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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.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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HSC-SN-17-1072
Identifier Type: -
Identifier Source: org_study_id