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| ID | Type | Description | Link |
|---|---|---|---|
| R15NR018050 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Nursing Research (NINR) | NIH |
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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)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active tDCS | Experimental |
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| Sham tDCS | Placebo Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Active tDCS | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | baseline, week 3 |
| Measure | Description | Time Frame |
|---|---|---|
| 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.
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hyochol Ahn, PhD, RN, MSN | The University of Texas Health Science Center, Houston | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Texas Health Science Center at Houston | Houston | Texas | 77030 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40040747 | Derived | Lee 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. | |
| 39548963 | Derived | Park 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Active tDCS | tDCS with a constant current intensity of 2 mA was applied for 20 minutes five times a week (Monday to Friday) for 3 weeks via the Soterix 1 × 1 tDCS mini-CT Stimulator device (Soterix Medical Inc., New York, NY, USA; 6.5 inches long, 3 inches wide, 0.7 inches thick) with headgear and 5 × 7 cm sponge electrodes. |
| FG001 | Sham tDCS | tDCS with a constant current intensity of 2 mA was applied for 30 seconds out of 20 minutes five times a week (Monday to Friday) for 3 weeks via the Soterix 1 × 1 tDCS mini-CT Stimulator device (Soterix Medical Inc., New York, NY, USA; 6.5 inches long, 3 inches wide, 0.7 inches thick) with headgear and 5 × 7 cm sponge electrodes. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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We analyzed the data from subjects who completed the study only.
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| ID | Title | Description |
|---|---|---|
| BG000 | Active tDCS | 2mA current is applied for 20 minutes. |
| BG001 | Sham tDCS | 2mA current is applied for 30 seconds. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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). | Comparison of pain intensity changes between two groups at 3 weeks from baseline. | Posted | Mean | Standard Deviation | score on a scale | baseline, week 3 |
|
3 weeks, from the first day of tDCS session to the last day.
All participants are assessed for adverse events, but none observed.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Active tDCS | 2mA current is applied for 20 minutes. | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Hyochol Ahn | Florida State University | 850-644-2647 | hahn@fsu.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 7, 2019 | Nov 4, 2022 | Prot_SAP_001.pdf |
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| Sham tDCS | Device | 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. |
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| 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. | 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. | 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. | week 3 |
| 35690388 | Derived | Martorella 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. |
| BG002 |
| Total |
Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Units | Counts |
|---|---|
| Participants |
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| Secondary | 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.
| All Subjects completed fNIRS. | Posted | Mean | Standard Deviation | Pearson correlation coefficient | Baseline, week1, week2, and week 3 |
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| Secondary | 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. | All participants completed tDCS experience questionnaire. | Posted | Mean | Standard Deviation | score on a scale | week 3 |
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|
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| Secondary | 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. | Participants who experienced and reported any side effect. | Posted | Count of Participants | Participants | week 3 |
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|
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| Secondary | 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. | All participants completed full tDCS protocol. | Posted | Count of Participants | Participants | week 3 |
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| 61 |
| 0 |
| 61 |
| 0 |
| 61 |
| EG001 | Sham tDCS | 2mA current is applied for 30 seconds. | 0 | 62 | 0 | 62 | 0 | 62 |
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| Connectivity between PFC and M1_S1 cortices at baseline |
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| Connectivity within Primary motor-somatosensory cortices at week 1 |
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| Connectivity within Prefrontal cortex at week 1 |
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| Connectivity between PFC and M1_S1 cortices at week 1 |
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| Connectivity within Primary motor-somatosensory cortices at week 2 |
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| Connectivity within Prefrontal cortex at week 2 |
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| Connectivity between PFC and M1_S1 cortices at week 2 |
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| Connectivity within Primary motor-somatosensory cortices at week 3 |
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| Connectivity within Prefrontal cortex at week 3 |
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| Connectivity between PFC and M1_S1 cortices at week 3 |
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