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| ID | Type | Description | Link |
|---|---|---|---|
| R01NR019051 | U.S. NIH Grant/Contract | View source | |
| R01NR019051-03S1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Nursing Research (NINR) | NIH |
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This clinical trial aims to evaluate whether a 2 week regimen of transcranial direct current stimulation (tDCS) paired with mindfulness-based meditation (MBM) can improve pain modulation, reduce clinical pain, and alleviate osteoarthritis (OA)-related symptoms in patients with knee OA.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| active tDCS paired with active MBM, | Experimental |
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| sham tDCS paired with active MBM | Active Comparator |
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| active tDCS paired with sham MBM | Active Comparator |
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| sham tDCS paired with sham MBM | Sham Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| active tDCS paired with active MBM | Device | Active tDCS with a constant current intensity of 2 milli ampere (mA) will be applied for 20 minutes per session daily for 2 weeks via the Soterix 1x1 tDCS mini-CT Stimulator device with headgear and saline-soaked surface sponge electrodes. The meditation intervention will be applied simultaneously with tDCS for 20 minutes per session daily for 2 weeks by a recorded meditation. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Numeric Rating Score (NRS) of Pain | The Numeric Rating Scale (NRS) is a subjective measure of pain intensity. The NRS total score ranges from 0 (no pain) to 100 (most intense pain imaginable). Change in NRS = Week 2 (post-intervention) NRS - Baseline (pre-intervention) NRS. A decrease in NRS score indicates improvement. | baseline, week 2 (after 10 tDCS sessions) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC). | Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC): 26 question index to assess knee OA pain (0-20 scale), function (0-68 scale), and stiffness (0-8 scale). The total WOAMC score is the sum of the 3 sub scales for a total score range from 0-96. Change in total WOMAC score = Week 2 total WOMAC score - Baseline (pre-intervention) total WOMAC score. The lower change scores represents improvement in pain, movement, and stiffness. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hyochol Ahn, PhD,RN,MSN | University of Arizona | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Arizona | Tucson | Arizona | 85721 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41917434 | Derived | Park J, Lee C, Lin L, Fain MJ, Telkes I, Dahmer S, Park L, Hoang J, Miao H, Ahn H. A randomized trial of a digitally delivered, home-based neuromodulation and mindfulness intervention for pain management in older adults with knee osteoarthritis. NPJ Digit Med. 2026 Mar 31;9(1):397. doi: 10.1038/s41746-026-02577-7. |
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A total of 208 participants consented to participate in the study. However, 8 participants withdrew due to being unable to attend the remaining sessions and assessments.
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| ID | Title | Description |
|---|---|---|
| FG000 | active tDCS paired with active MBM | A 2mA current and mindfulness-based meditation are applied for 20 minutes |
| FG001 | sham tDCS paired with active MBM | A 2mA current is applied for 30 seconds, and mindfulness-based meditation is conducted for 20 minutes. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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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 | Jul 24, 2024 |
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| sham tDCS paired with active MBM | 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 during each 20-minute session, conducted daily for 2 weeks. The meditation intervention will be applied simultaneously with tDCS for 20 minutes per session daily for 2 weeks by a recorded meditation. |
|
| active tDCS paired with sham MBM | Device | Active tDCS with a constant current intensity of 2 milli ampere (mA) will be applied for 20 minutes per session daily for 2 weeks via the Soterix 1x1 tDCS mini-CT Stimulator device with headgear and saline-soaked surface sponge electrodes. The sham MBM intervention will be delivered via a CD player that will look identical in both active and sham MBM. |
|
| sham tDCS paired with sham MBM | 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 during each 20-minute session, conducted daily for 2 weeks. The sham MBM intervention will be delivered via a CD player that will look identical in both active and sham MBM. |
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| baseline, week 2 (after 10 tDCS sessions) |
| FG002 | active tDCS paired with sham MBM | A 2mA current is applied for 20 minutes, and mindfulness-based meditation without the specific instructions is conducted for 20 minutes. |
| FG003 | sham tDCS paired with sham MBM | A 2mA current is applied for 30 seconds, and mindfulness-based meditation without the specific instructions is conducted for 20 minutes. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Active tDCS Paired With Active MBM, | A transcranial direct current stimulation (tDCS) of 2mA is applied for 20 minutes, where a constant current of 2mA is delivered to the scalp through electrodes to modulate neural activity. Alongside this, mindfulness-based meditation is conducted for 20 minutes, focusing on cultivating awareness and concentration through practices such as breath observation and mindful awareness of thoughts and sensations. Both interventions are applied simultaneously, aiming to investigate their combined effects on brain function and mental state. |
| BG001 | Sham tDCS Paired With Active MBM | A 2mA transcranial direct current stimulation (tDCS) is applied for 30 seconds. Simultaneously, mindfulness-based meditation is conducted for 20 minutes, involving practices aimed at enhancing awareness and focus, such as observing the breath and maintaining attention to present-moment experiences. |
| BG002 | Active tDCS Paired With Sham MBM | A 2mA transcranial direct current stimulation (tDCS) is applied for 20 minutes, with a constant current of 2mA delivered through electrodes placed on the scalp to modulate neural activity in targeted brain regions. Simultaneously, mindfulness-based meditation without specific instructions is conducted for 20 minutes. In this meditation practice, participants are encouraged to focus on their breath and cultivate general awareness of their thoughts and sensations, without any particular guidance on how to direct their attention. |
| BG003 | Sham tDCS Paired With Sham MBM | A 2mA transcranial direct current stimulation (tDCS) is applied for 30 seconds. Simultaneously, mindfulness-based meditation without specific instructions is conducted for 20 minutes. In this practice, participants are encouraged to cultivate awareness and attention to their thoughts, feelings, and bodily sensations without any particular guidance or structured focus, allowing for an open-ended, self-directed meditation experience. |
| BG004 | Total | Total of all reporting groups |
| 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 | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants | No |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants | No |
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| Race (NIH/OMB) | Count of Participants | Participants | No |
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| 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 Numeric Rating Score (NRS) of Pain | The Numeric Rating Scale (NRS) is a subjective measure of pain intensity. The NRS total score ranges from 0 (no pain) to 100 (most intense pain imaginable). Change in NRS = Week 2 (post-intervention) NRS - Baseline (pre-intervention) NRS. A decrease in NRS score indicates improvement. | Posted | Mean | Standard Deviation | units on a scale | baseline, week 2 (after 10 tDCS sessions) |
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| Secondary | Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC). | Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC): 26 question index to assess knee OA pain (0-20 scale), function (0-68 scale), and stiffness (0-8 scale). The total WOAMC score is the sum of the 3 sub scales for a total score range from 0-96. Change in total WOMAC score = Week 2 total WOMAC score - Baseline (pre-intervention) total WOMAC score. The lower change scores represents improvement in pain, movement, and stiffness. | Comparison of WOMAC score changes between four groups at 2 weeks from baseline. | Posted | Mean | Standard Deviation | units on a scale | baseline, week 2 (after 10 tDCS sessions) |
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about 4 months
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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 paired with active MBM, | active tDCS paired with active MBM: Active tDCS with a constant current intensity of 2 milli ampere( mA)will be applied for 20 minutes per session daily for 2 weeks via the Soterix 1x1 tDCS mini-CT Stimulator device with headgear and saline-soaked surface sponge electrodes. The meditation intervention will be applied simultaneously with tDCS for 20 minutes per session daily for 2 weeks by a recorded meditation. | 0 | 53 | 0 | 53 | 0 | 53 |
| EG001 | sham tDCS paired with active MBM | sham tDCS paired with active MBM: For sham stimulation, the electrodes will be placed in the same positions as for active stimulation, but the stimulator will only deliver 2(milli ampere) mA current for 30 seconds. The meditation intervention will be applied simultaneously with tDCS for 20 minutes per session daily for 2 weeks by a recorded meditation. | 0 | 53 | 0 | 53 | 0 | 53 |
| EG002 | active tDCS paired with sham MBM | active tDCS paired with sham MBM: Active tDCS with a constant current intensity of 2 mA will be applied for 20 minutes per session daily for 2 weeks via the Soterix 1x1 tDCS mini-CT Stimulator device with headgear and saline-soaked surface sponge electrodes. The sham MBM intervention will be delivered via a CD player that will look identical in both active and sham MBM. | 0 | 50 | 0 | 50 | 0 | 50 |
| EG003 | sham tDCS paired with sham MBM | sham tDCS paired with sham MBM: 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. The sham MBM intervention will be delivered via a CD player that will look identical in both active and sham MBM. | 0 | 52 | 0 | 52 | 0 | 52 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Hyochol Brian Ahn | The University of Arizona | 520.626.1769 | hbrian@arizona.edu |
| Oct 23, 2025 |
| Prot_SAP_001.pdf |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| OG002 | active tDCS paired with sham MBM | active tDCS paired with sham MBM: Active tDCS with a constant current intensity of 2 mA will be applied for 20 minutes per session daily for 2 weeks via the Soterix 1x1 tDCS mini-CT Stimulator device with headgear and saline-soaked surface sponge electrodes. The sham MBM intervention will be delivered via a CD player that will look identical in both active and sham MBM. |
| OG003 | sham tDCS paired with sham MBM | sham tDCS paired with sham MBM: 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. The sham MBM intervention will be delivered via a CD player that will look identical in both active and sham MBM. |
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