An interventional study of Active tDCS and Sham tDCS in Osteo Arthritis Knee, sponsored by Florida State University. Completed at 1 site in United States. Open to participants aged 50 Years to 85 Years. Per ClinicalTrials.gov, last updated 2023-05-10.
Sponsored by Florida State University · Not applicable, Interventional, and Treatment
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)
4,398 studies on the registry are indexed under Osteoarthritis; 582 are open to participants now.
This study's enrollment of 123 is above the median of 70 across 3,440 interventional studies indexed under Osteoarthritis.
Browse Osteoarthritis studies →Florida State University is the lead sponsor of 241 studies on the registry; 46 are open to participants now.
Of its 15 completed or terminated interventional studies of FDA-regulated products, 9 (60%) have results posted.
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Exclusion Criteria:
Device: Active tDCS
Device: Sham tDCS
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.
Also known as: 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.
Also known as: Soterix 1x1 tDCS mini-CT Stimulator
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).
Time frame: baseline, week 3
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: week 3
| Milestone | Active tDCS | Sham tDCS |
|---|---|---|
| Started | 61 | 62 |
| Completed | 60 | 60 |
| Not completed | 1 | 2 |
| Withdrew: Withdrawal by subject | 1 | 2 |
The Numeric Rating Scale (NRS) total score ranges from 0 (no pain) to 100 (most intense pain imaginable).
| score on a scale | Active tDCS | Sham tDCS |
|---|---|---|
| Change in Clinical Pain as Assessed by the Numeric Rating Scale (NRS) for Pain | -24.07 ± 21.55 | -1.08 ± 16.46 |
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.
| Pearson correlation coefficient | Active tDCS | Sham tDCS |
|---|---|---|
| Connectivity within Primary motor-somatosensory cortices at baseline | 0.18 ± 0.21 | 0.12 ± 0.17 |
| Connectivity within Prefrontal cortex at baseline | 0.10 ± 0.12 | 0.09 ± 0.11 |
| Connectivity between PFC and M1_S1 cortices at baseline | -0.12 ± 0.17 | -0.12 ± 0.16 |
| Connectivity within Primary motor-somatosensory cortices at week 1 | 0.17 ± 0.20 | 0.14 ± 0.18 |
| Connectivity within Prefrontal cortex at week 1 | 0.09 ± 0.13 | 0.16 ± 0.15 |
| Connectivity between PFC and M1_S1 cortices at week 1 | -0.13 ± 0.12 | -0.17 ± 0.17 |
| Connectivity within Primary motor-somatosensory cortices at week 2 | 0.17 ± 0.17 | 0.14 ± 0.19 |
| Connectivity within Prefrontal cortex at week 2 | 0.09 ± 0.09 | 0.10 ± 0.11 |
| Connectivity between PFC and M1_S1 cortices at week 2 | -0.14 ± 0.13 | -0.15 ± 0.20 |
| Connectivity within Primary motor-somatosensory cortices at week 3 | 0.18 ± 0.14 | 0.17 ± 0.14 |
| Connectivity within Prefrontal cortex at week 3 | 0.10 ± 0.11 | 0.10 ± 0.10 |
| Connectivity between PFC and M1_S1 cortices at week 3 | -0.14 ± 0.10 | -0.17 ± 0.15 |
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.
| score on a scale | Active tDCS | Sham tDCS |
|---|---|---|
| Acceptability as Measured by the tDCs Experience Questionnaire | 62.93 ± 8.48 | 64.93 ± 9.66 |
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 | Active tDCS | Sham tDCS |
|---|---|---|
| Number of Participants With Possible Side Effects of Treatment | 0 | 0 |
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.
| Participants | Active tDCS | Sham tDCS |
|---|---|---|
| Feasibility as Assessed by the Number of Participants That Complete the Full tDCS Protocol | 60 | 60 |
Collected over 3 weeks, from the first day of tDCS session to the last day.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Active tDCS | 0/61 (0%) | 0/61 (0%) | 0/61 (0%) |
| Sham tDCS | 0/62 (0%) | 0/62 (0%) | 0/62 (0%) |
We analyzed the data from subjects who completed the study only.
| Age, Continuous(years) | Active tDCS | Sham tDCS | Total |
|---|---|---|---|
| Mean | 65.32 ± 8.41 | 66.60 ± 8.43 | 65.96 ± 8.407 |
| Sex: Female, Male(Participants) | Active tDCS | Sham tDCS | Total |
|---|---|---|---|
| Female | 40 | 42 | 82 |
| Male | 20 | 18 | 38 |
| Ethnicity (NIH/OMB)(Participants) | Active tDCS | Sham tDCS | Total |
|---|---|---|---|
| Hispanic or Latino | 7 | 4 | 11 |
| Not Hispanic or Latino | 53 | 56 | 109 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Active tDCS | Sham tDCS | Total |
|---|---|---|---|
| American Indian or Alaska Native | 2 | 0 | 2 |
| Asian | 6 | 2 | 8 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 19 | 22 | 41 |
| White | 33 | 36 | 69 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
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Florida State University