Osteo Arthritis KneeNCT04016272
Self-Administered Transcranial Direct Current Stimulation for Pain in Older Adults With Knee Osteoarthritis
A study testing Active tDCS in people with Osteo Arthritis Knee, run by Florida State University at 1 site in United States.
Trial 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) Read more about this study
- Who is it for?
- Ages 50 to 85 years
- Conditions the study is for
- Osteo Arthritis Knee
- What is being tested?
- Active tDCS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 123 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Oct 2019to 5 Nov 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 9Show fewer
- 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 locations and contacts
1 site in 1 country.
United States1 site
The University of Texas Health Science Center at Houston
Houston, Texas, 77030
About this study
Official title: Self-Administered Transcranial Direct Current Stimulation for Pain in Older Adults With Knee Osteoarthritis: A Phase II Randomized Sham-Controlled Trial
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)
- Conditions
- Osteo Arthritis Knee
- Being tested
- Active tDCS, Sham tDCS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active tDCSDevice
Also called Soterix 1x1 tDCS mini-CT Stimulator
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.
Sham tDCSDevice
Also called Soterix 1x1 tDCS mini-CT Stimulator
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.
| Study group | Role | What they receive |
|---|---|---|
| Active tDCS | Experimental | Not described Receives: Device: Active tDCS |
| Sham tDCS | Placebo comparator | Not described Receives: Device: Sham tDCS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Clinical Pain as Assessed by the Numeric Rating Scale (NRS) for Pain
The Numeric Rating Scale (NRS) total score ranges from 0 (no pain) to 100 (most intense pain imaginable).
Measured: baseline, week 3
Secondary outcomes (4)
Change in Pain Related Cortical Response Using a Continuous Wave, Multichannel Functional Near-infrared Spectroscopy (fNIRS) Imaging System
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 and punctate pain stimulation and correlation values will be presented in the form of figures.
- Specify the full scale: Pearson correlation coefficient (r) between pairs of brain regions (fNIRS channels).
- A value of r=0 indicates that two brain regions were functionally disconnected.
- Greater absolute r values denote stronger connections. However, this does not indicate a better or worse result but only a different type of connectivity on a macroscale (when considering several fNIRS channels).
- We used |r|>0.3 (absolute value of r greater than 0.3) to extract meaningful functional connections.
Measured: Baseline, week1, week2, and week 3
Acceptability as Measured by the tDCs Experience Questionnaire
The tDCS experience questionnaire contains 10 questions based on a scale from 0-10, 0 being strongly disagree and 10 being strongly agree.
Higher scores indicating greater acceptability for 7 questions and lower scores indicating greater acceptability for 3 questions resulting most desirable score of a 70.
Measured: week 3
Number of Participants With Possible Side Effects of Treatment
If any side effects are reported, the degree of relatedness to the intervention will be assessed on a 10-point scale, from 0 (not at all) to 10 (to a high degree). The questionnaire ask to what extend did the participant experienced symptoms like, tingling, itching sensation, burning sensation, pain at the stimulation site, fatigue, nervousness, headache, difficulty concentrating, or mood change.
Measured: week 3
Feasibility as Assessed by the Number of Participants That Complete the Full tDCS Protocol
We will calculate the percentage of participants who a) meet the inclusion criteria, b) agree to be randomly assigned, c) complete the full tDCS protocol, and d) attend the follow-up assessment.
Measured: week 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2019
- Study start18 Oct 2019
- Primary completion5 Nov 2021
- Study completion5 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Osteo Arthritis KneeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 123 participants (actual)
Sponsor and investigators
- Lead sponsor
- Florida State University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Responsible party
- Principal investigator, Hyochol Ahn, PhD, Florida State University
- Investigators
- Hyochol Ahn, PhD, RN, MSN, Principal investigator, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04016272
- Sponsor's protocol ID
- HSC-SN-19-0469
- Other IDs
- R15NR018050
- Status last verified
- May 2023
- First submitted
- 9 Jul 2019
- Last updated
- 10 May 2023
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Lee C, Kim H, Kim S, Kim Y, Sun X, Chen CX, Park J, Pellegrini C, Garcia DO, Chen NK, Kwoh CK, Ahn H. Predicting Heterogeneity of Treatment Effects to Transcranial Direct Current Stimulation for Knee Osteoarthritis Pain and Symptoms: A Machine Learning Approach. Clin J Pain. 2026 Apr 1;42(4):e1364. doi: 10.1097/AJP.0000000000001364.
PubMed 41626992Lee C, Park J, Kwoh CK, Fain M, Park L, Ahn H. Home-Based, Remotely Supervised Transcranial Direct Current Stimulation Improves the Overall Pain Experience of Older Adults With Knee Osteoarthritis. Pain Res Manag. 2025 Feb 24;2025:1783171. doi: 10.1155/prm/1783171. eCollection 2025.
PubMed 40040747Park J, Tong H, Kang Y, Miao H, Lin L, Fox RS, Telkes I, Martorella G, Ahn H. Comparison of responders and nonresponders with knee osteoarthritis after transcranial direct current stimulation. Pain Manag. 2024 Sep;14(9):507-518. doi: 10.1080/17581869.2024.2429943. Epub 2024 Nov 16.
PubMed 39548963Martorella G, Mathis K, Miao H, Wang D, Park L, Ahn H. Self-administered transcranial direct current stimulation for pain in older adults with knee osteoarthritis: A randomized controlled study. Brain Stimul. 2022 Jul-Aug;15(4):902-909. doi: 10.1016/j.brs.2022.06.003. Epub 2022 Jun 8.
PubMed 35690388
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Self-Administered Transcranial Direct Current Stimulation for Pain in Older Adults With Knee Osteoarthritis: A Phase II Randomized Sham-Controlled Trial
- ClinicalTrials.gov ID
- NCT04016272
- Acronym / sponsor ID
- HSC-SN-19-0469
- Conditions
- Osteo Arthritis Knee
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 123 participants (actual)
- Lead sponsor
- Florida State UniversityUniversity, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Study start
- 18 Oct 2019 (actual)
- Primary completion
- 5 Nov 2021 (actual)
- Study completion
- 5 Nov 2021 (actual)
- First posted
- 11 Jul 2019 (actual)
- Results
- Posted 10 May 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active tDCS | Experimental | Device: Active tDCS |
| Sham tDCS | Placebo comparator | Device: Sham tDCS |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Active tDCSAlso: Soterix 1x1 tDCS mini-CT StimulatortDCS 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. | Device | Active tDCS |
| Sham tDCSAlso: Soterix 1x1 tDCS mini-CT StimulatorFor 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. | Device | Sham tDCS |
Primary outcome
Change in Clinical Pain as Assessed by the Numeric Rating Scale (NRS) for Pain
Time frame: baseline, week 3
The Numeric Rating Scale (NRS) total score ranges from 0 (no pain) to 100 (most intense pain imaginable).
4 secondary outcomes
Change in Pain Related Cortical Response Using a Continuous Wave, Multichannel Functional Near-infrared Spectroscopy (fNIRS) Imaging System
Time frame: Baseline, week1, week2, and week 3
Acceptability as Measured by the tDCs Experience Questionnaire
Time frame: week 3
Number of Participants With Possible Side Effects of Treatment
Time frame: week 3
Feasibility as Assessed by the Number of Participants That Complete the Full tDCS Protocol
Time frame: week 3
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 41626992Lee C, Kim H, Kim S, Kim Y, Sun X, Chen CX, Park J, Pellegrini C, Garcia DO, Chen NK, Kwoh CK, Ahn H. Predicting Heterogeneity of Treatment Effects to Transcranial Direct Current Stimulation for Knee Osteoarthritis Pain and Symptoms: A Machine Learning Approach. Clin J Pain. 2026 Apr 1;42(4):e1364. doi: 10.1097/AJP.0000000000001364.
- Derived from this study: PubMed 40040747Lee C, Park J, Kwoh CK, Fain M, Park L, Ahn H. Home-Based, Remotely Supervised Transcranial Direct Current Stimulation Improves the Overall Pain Experience of Older Adults With Knee Osteoarthritis. Pain Res Manag. 2025 Feb 24;2025:1783171. doi: 10.1155/prm/1783171. eCollection 2025.
- Derived from this study: PubMed 39548963Park J, Tong H, Kang Y, Miao H, Lin L, Fox RS, Telkes I, Martorella G, Ahn H. Comparison of responders and nonresponders with knee osteoarthritis after transcranial direct current stimulation. Pain Manag. 2024 Sep;14(9):507-518. doi: 10.1080/17581869.2024.2429943. Epub 2024 Nov 16.
- Derived from this study: PubMed 35690388Martorella G, Mathis K, Miao H, Wang D, Park L, Ahn H. Self-administered transcranial direct current stimulation for pain in older adults with knee osteoarthritis: A randomized controlled study. Brain Stimul. 2022 Jul-Aug;15(4):902-909. doi: 10.1016/j.brs.2022.06.003. Epub 2022 Jun 8.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hyochol Ahn, PhD, RN, MSN principal investigator
The University of Texas Health Science Center, Houston
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active tDCS in people with Osteo Arthritis Knee, run by Florida State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 May 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Clinical Pain as Assessed by the Numeric Rating Scale (NRS) for Pain (time frame: baseline, week 3). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04016272, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 May 2023.