Trial Outcomes & Findings for Self Transcranial Direct Current Stimulation and Mindfulness-based Meditation for Pain in Older Adults With Knee Osteoarthritis (NCT NCT03747640)
NCT ID: NCT03747640
Last Updated: 2022-03-25
Results Overview
The NRS assess average pain over the past 24 hours from 0 (no pain) to 100 (most intense pain imaginable).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
30 participants
Primary outcome timeframe
baseline, 2 weeks
Results posted on
2022-03-25
Participant Flow
Participant milestones
| Measure |
tDCS With Mindfulness-based Meditation
Self Transcranial Direct Current Stimulation (tDCS) with Mindfulness-Based Meditation
Self Transcranial Direct Current Stimulation (tDCS): 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 (Soterix Medical Inc., New York; 6.5 inches long, 3 inches wide, 0.7 inches thick) with headgear and 5x7 cm saline-soaked surface sponge electrodes.
mindfulness-based meditation: The meditation intervention will be delivered by a recorded device that participants will be given together with the tDCS. All meditation instruction recordings will be done by an experienced mind-body intervention specialist and installed in a user-friendly MP3 player.
|
Sham tDCS With Sham Meditation
Sham self Transcranial Direct Current Stimulation (tDCS) with sham Meditation
Sham Self Transcranial Direct Current Stimulation (tDCS): 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.
sham meditation: For sham meditation, the participants will be instructed, approximately every 2-3 minutes, to take deep breaths as we sit in meditation. Time spent giving instructions in the sham meditation intervention will be matched to time spent in the mindfulness intervention.
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|---|---|---|
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Overall Study
STARTED
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15
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15
|
|
Overall Study
COMPLETED
|
15
|
15
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Self Transcranial Direct Current Stimulation and Mindfulness-based Meditation for Pain in Older Adults With Knee Osteoarthritis
Baseline characteristics by cohort
| Measure |
tDCS With Mindfulness-based Meditation
n=15 Participants
Self Transcranial Direct Current Stimulation (tDCS) with Mindfulness-Based Meditation
Self Transcranial Direct Current Stimulation (tDCS): 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 (Soterix Medical Inc., New York; 6.5 inches long, 3 inches wide, 0.7 inches thick) with headgear and 5x7 cm saline-soaked surface sponge electrodes.
mindfulness-based meditation: The meditation intervention will be delivered by a recorded device that participants will be given together with the tDCS. All meditation instruction recordings will be done by an experienced mind-body intervention specialist and installed in a user-friendly MP3 player.
|
Sham tDCS With Sham Meditation
n=15 Participants
Sham self Transcranial Direct Current Stimulation (tDCS) with sham Meditation
Sham Self Transcranial Direct Current Stimulation (tDCS): 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.
sham meditation: For sham meditation, the participants will be instructed, approximately every 2-3 minutes, to take deep breaths as we sit in meditation. Time spent giving instructions in the sham meditation intervention will be matched to time spent in the mindfulness intervention.
|
Total
n=30 Participants
Total of all reporting groups
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|---|---|---|---|
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Age, Continuous
|
59.47 years
STANDARD_DEVIATION 6.38 • n=5 Participants
|
59.47 years
STANDARD_DEVIATION 7.63 • n=7 Participants
|
59.47 years
STANDARD_DEVIATION 6.91 • n=5 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
5 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
African American
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
5 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
15 participants
n=5 Participants
|
15 participants
n=7 Participants
|
30 participants
n=5 Participants
|
|
Education
High School'
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Education
2-year College
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Education
4- year College
|
4 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Education
Master's Degree
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Education
Doctoral Degree
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Body Mass Index
|
27.9 kg / m^2
STANDARD_DEVIATION 6.35 • n=5 Participants
|
27.17 kg / m^2
STANDARD_DEVIATION 5.19 • n=7 Participants
|
27.54 kg / m^2
STANDARD_DEVIATION 5.71 • n=5 Participants
|
|
Clinical Pain as Assessed by a Numeric Rating Scale for Pain (NRS)
|
55.33 score on a scale
STANDARD_DEVIATION 21 • n=5 Participants
|
40.67 score on a scale
STANDARD_DEVIATION 13.35 • n=7 Participants
|
48 score on a scale
STANDARD_DEVIATION 18.83 • n=5 Participants
|
|
Clinical Pain as Assessed by the Western Ontario and McMaster Universities Osteoarthritis Index
|
42.27 score on a scale
STANDARD_DEVIATION 23.30 • n=5 Participants
|
36.33 score on a scale
STANDARD_DEVIATION 16.14 • n=7 Participants
|
39.30 score on a scale
STANDARD_DEVIATION 19.92 • n=5 Participants
|
|
Experimental Pain Sensitivity as measured by Conditioned Pain Modulation (CPM)
|
0.67 kilograms force (kgf)
STANDARD_DEVIATION 0.68 • n=5 Participants
|
0.94 kilograms force (kgf)
STANDARD_DEVIATION 1.25 • n=7 Participants
|
.81 kilograms force (kgf)
STANDARD_DEVIATION 1.00 • n=5 Participants
|
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Experimental Pain Sensitivity as Assessed by Pressure Pain Threshold, Medial Knee
|
3.54 kilograms force (kgf)
STANDARD_DEVIATION 2.18 • n=5 Participants
|
3.80 kilograms force (kgf)
STANDARD_DEVIATION 1.56 • n=7 Participants
|
3.67 kilograms force (kgf)
STANDARD_DEVIATION 1.87 • n=5 Participants
|
|
Experimental Pain Sensitivity as Assessed by Pressure Pain Threshold, lateral Knee
|
3.47 kilograms force (kgf)
STANDARD_DEVIATION 2.18 • n=5 Participants
|
3.96 kilograms force (kgf)
STANDARD_DEVIATION 1.88 • n=7 Participants
|
3.72 kilograms force (kgf)
STANDARD_DEVIATION 2.01 • n=5 Participants
|
|
Experimental Pain Sensitivity as Assessed by Cold Pain Intensity
|
78.33 score on a scale
STANDARD_DEVIATION 19.61 • n=5 Participants
|
77.33 score on a scale
STANDARD_DEVIATION 23.14 • n=7 Participants
|
77.83 score on a scale
STANDARD_DEVIATION 21.08 • n=5 Participants
|
PRIMARY outcome
Timeframe: baseline, 2 weeksThe NRS assess average pain over the past 24 hours from 0 (no pain) to 100 (most intense pain imaginable).
Outcome measures
| Measure |
tDCS With Mindfulness-based Meditation
n=15 Participants
Self Transcranial Direct Current Stimulation (tDCS) with Mindfulness-Based Meditation
Self Transcranial Direct Current Stimulation (tDCS): 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 (Soterix Medical Inc., New York; 6.5 inches long, 3 inches wide, 0.7 inches thick) with headgear and 5x7 cm saline-soaked surface sponge electrodes.
mindfulness-based meditation: The meditation intervention will be delivered by a recorded device that participants will be given together with the tDCS. All meditation instruction recordings will be done by an experienced mind-body intervention specialist and installed in a user-friendly MP3 player.
|
Sham tDCS With Sham Meditation
n=15 Participants
Sham self Transcranial Direct Current Stimulation (tDCS) with sham Meditation
Sham Self Transcranial Direct Current Stimulation (tDCS): 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.
sham meditation: For sham meditation, the participants will be instructed, approximately every 2-3 minutes, to take deep breaths as we sit in meditation. Time spent giving instructions in the sham meditation intervention will be matched to time spent in the mindfulness intervention.
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|---|---|---|
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Change in Clinical Pain as Assessed by a Numeric Rating Scale for Pain (NRS)
|
-24.67 score on a scale
Standard Deviation 12.88
|
-3.33 score on a scale
Standard Deviation 10.63
|
SECONDARY outcome
Timeframe: baseline, 2 weeksThe WOMAC ranges from 0 to 96, with higher scores indicating worse osteoarthritis (OA) pain-related symptoms.
Outcome measures
| Measure |
tDCS With Mindfulness-based Meditation
n=15 Participants
Self Transcranial Direct Current Stimulation (tDCS) with Mindfulness-Based Meditation
Self Transcranial Direct Current Stimulation (tDCS): 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 (Soterix Medical Inc., New York; 6.5 inches long, 3 inches wide, 0.7 inches thick) with headgear and 5x7 cm saline-soaked surface sponge electrodes.
mindfulness-based meditation: The meditation intervention will be delivered by a recorded device that participants will be given together with the tDCS. All meditation instruction recordings will be done by an experienced mind-body intervention specialist and installed in a user-friendly MP3 player.
|
Sham tDCS With Sham Meditation
n=15 Participants
Sham self Transcranial Direct Current Stimulation (tDCS) with sham Meditation
Sham Self Transcranial Direct Current Stimulation (tDCS): 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.
sham meditation: For sham meditation, the participants will be instructed, approximately every 2-3 minutes, to take deep breaths as we sit in meditation. Time spent giving instructions in the sham meditation intervention will be matched to time spent in the mindfulness intervention.
|
|---|---|---|
|
Change in Clinical Pain as Assessed by the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
|
-12.60 score on a scale
Standard Deviation 17.97
|
-0.53 score on a scale
Standard Deviation 10.01
|
SECONDARY outcome
Timeframe: baselineThe 7-item PROMIS Anxiety Short Form assesses the pure domain of anxiety in individuals age 18 and older, and each item on the measure is rated on a 5-point scale (1=never; 2=rarely; 3=sometimes; 4=often; and 5=always) with a range in score from 7 to 35 with higher scores indicating greater severity of anxiety.
Outcome measures
| Measure |
tDCS With Mindfulness-based Meditation
n=15 Participants
Self Transcranial Direct Current Stimulation (tDCS) with Mindfulness-Based Meditation
Self Transcranial Direct Current Stimulation (tDCS): 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 (Soterix Medical Inc., New York; 6.5 inches long, 3 inches wide, 0.7 inches thick) with headgear and 5x7 cm saline-soaked surface sponge electrodes.
mindfulness-based meditation: The meditation intervention will be delivered by a recorded device that participants will be given together with the tDCS. All meditation instruction recordings will be done by an experienced mind-body intervention specialist and installed in a user-friendly MP3 player.
|
Sham tDCS With Sham Meditation
n=15 Participants
Sham self Transcranial Direct Current Stimulation (tDCS) with sham Meditation
Sham Self Transcranial Direct Current Stimulation (tDCS): 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.
sham meditation: For sham meditation, the participants will be instructed, approximately every 2-3 minutes, to take deep breaths as we sit in meditation. Time spent giving instructions in the sham meditation intervention will be matched to time spent in the mindfulness intervention.
|
|---|---|---|
|
Psychosocial Symptoms as Assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety-short Form
|
17.13 score on a scale
Standard Deviation 5.66
|
16.20 score on a scale
Standard Deviation 5.41
|
SECONDARY outcome
Timeframe: 2 weeksThe 7-item PROMIS Anxiety Short Form assesses the pure domain of anxiety in individuals age 18 and older, and each item on the measure is rated on a 5-point scale (1=never; 2=rarely; 3=sometimes; 4=often; and 5=always) with a range in score from 7 to 35 with higher scores indicating greater severity of anxiety.
Outcome measures
| Measure |
tDCS With Mindfulness-based Meditation
n=15 Participants
Self Transcranial Direct Current Stimulation (tDCS) with Mindfulness-Based Meditation
Self Transcranial Direct Current Stimulation (tDCS): 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 (Soterix Medical Inc., New York; 6.5 inches long, 3 inches wide, 0.7 inches thick) with headgear and 5x7 cm saline-soaked surface sponge electrodes.
mindfulness-based meditation: The meditation intervention will be delivered by a recorded device that participants will be given together with the tDCS. All meditation instruction recordings will be done by an experienced mind-body intervention specialist and installed in a user-friendly MP3 player.
|
Sham tDCS With Sham Meditation
n=15 Participants
Sham self Transcranial Direct Current Stimulation (tDCS) with sham Meditation
Sham Self Transcranial Direct Current Stimulation (tDCS): 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.
sham meditation: For sham meditation, the participants will be instructed, approximately every 2-3 minutes, to take deep breaths as we sit in meditation. Time spent giving instructions in the sham meditation intervention will be matched to time spent in the mindfulness intervention.
|
|---|---|---|
|
Psychosocial Symptoms as Assessed by the PROMIS Anxiety-short Form
|
14.27 score on a scale
Standard Deviation 6.71
|
14.27 score on a scale
Standard Deviation 5.68
|
SECONDARY outcome
Timeframe: baselineThe 8-item PROMIS Depression Short Form assesses the pure domain of depression in individuals age 18 and older, and each item on the measure is rated on a 5-point scale (1=never; 2=rarely; 3=sometimes; 4=often; and 5=always) with a range in score from 8 to 40 with higher scores indicating greater severity of depression.
Outcome measures
| Measure |
tDCS With Mindfulness-based Meditation
n=15 Participants
Self Transcranial Direct Current Stimulation (tDCS) with Mindfulness-Based Meditation
Self Transcranial Direct Current Stimulation (tDCS): 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 (Soterix Medical Inc., New York; 6.5 inches long, 3 inches wide, 0.7 inches thick) with headgear and 5x7 cm saline-soaked surface sponge electrodes.
mindfulness-based meditation: The meditation intervention will be delivered by a recorded device that participants will be given together with the tDCS. All meditation instruction recordings will be done by an experienced mind-body intervention specialist and installed in a user-friendly MP3 player.
|
Sham tDCS With Sham Meditation
n=15 Participants
Sham self Transcranial Direct Current Stimulation (tDCS) with sham Meditation
Sham Self Transcranial Direct Current Stimulation (tDCS): 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.
sham meditation: For sham meditation, the participants will be instructed, approximately every 2-3 minutes, to take deep breaths as we sit in meditation. Time spent giving instructions in the sham meditation intervention will be matched to time spent in the mindfulness intervention.
|
|---|---|---|
|
Psychosocial Symptoms as Assessed by PROMIS Depression-short Form
|
13.93 score on a scale
Standard Deviation 7.74
|
14.00 score on a scale
Standard Deviation 5.39
|
SECONDARY outcome
Timeframe: 2 weeksThe 8-item PROMIS Depression Short Form assesses the pure domain of depression in individuals age 18 and older, and each item on the measure is rated on a 5-point scale (1=never; 2=rarely; 3=sometimes; 4=often; and 5=always) with a range in score from 8 to 40 with higher scores indicating greater severity of depression.
Outcome measures
| Measure |
tDCS With Mindfulness-based Meditation
n=15 Participants
Self Transcranial Direct Current Stimulation (tDCS) with Mindfulness-Based Meditation
Self Transcranial Direct Current Stimulation (tDCS): 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 (Soterix Medical Inc., New York; 6.5 inches long, 3 inches wide, 0.7 inches thick) with headgear and 5x7 cm saline-soaked surface sponge electrodes.
mindfulness-based meditation: The meditation intervention will be delivered by a recorded device that participants will be given together with the tDCS. All meditation instruction recordings will be done by an experienced mind-body intervention specialist and installed in a user-friendly MP3 player.
|
Sham tDCS With Sham Meditation
n=15 Participants
Sham self Transcranial Direct Current Stimulation (tDCS) with sham Meditation
Sham Self Transcranial Direct Current Stimulation (tDCS): 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.
sham meditation: For sham meditation, the participants will be instructed, approximately every 2-3 minutes, to take deep breaths as we sit in meditation. Time spent giving instructions in the sham meditation intervention will be matched to time spent in the mindfulness intervention.
|
|---|---|---|
|
Psychosocial Symptoms as Assessed by PROMIS Depression-short Form
|
11.93 score on a scale
Standard Deviation 6.94
|
12.20 score on a scale
Standard Deviation 4.83
|
SECONDARY outcome
Timeframe: baselineThe 8-item PROMIS Sleep Disturbance Short Form assesses the pure domain of sleep disturbance in individuals age 18 and older, and each item on the measure is rated on a 5-point scale (1=never; 2=rarely; 3=sometimes; 4=often; and 5=always) with a range in score from 8 to 40 with higher scores indicating greater severity of sleep disturbance.
Outcome measures
| Measure |
tDCS With Mindfulness-based Meditation
n=15 Participants
Self Transcranial Direct Current Stimulation (tDCS) with Mindfulness-Based Meditation
Self Transcranial Direct Current Stimulation (tDCS): 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 (Soterix Medical Inc., New York; 6.5 inches long, 3 inches wide, 0.7 inches thick) with headgear and 5x7 cm saline-soaked surface sponge electrodes.
mindfulness-based meditation: The meditation intervention will be delivered by a recorded device that participants will be given together with the tDCS. All meditation instruction recordings will be done by an experienced mind-body intervention specialist and installed in a user-friendly MP3 player.
|
Sham tDCS With Sham Meditation
n=15 Participants
Sham self Transcranial Direct Current Stimulation (tDCS) with sham Meditation
Sham Self Transcranial Direct Current Stimulation (tDCS): 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.
sham meditation: For sham meditation, the participants will be instructed, approximately every 2-3 minutes, to take deep breaths as we sit in meditation. Time spent giving instructions in the sham meditation intervention will be matched to time spent in the mindfulness intervention.
|
|---|---|---|
|
Psychosocial Symptoms as Assessed by PROMIS Sleep Disturbance-short Form
|
23.87 score on a scale
Standard Deviation 7.22
|
23.67 score on a scale
Standard Deviation 7.49
|
SECONDARY outcome
Timeframe: 2 weeksThe 8-item PROMIS Sleep Disturbance Short Form assesses the pure domain of sleep disturbance in individuals age 18 and older, and each item on the measure is rated on a 5-point scale (1=never; 2=rarely; 3=sometimes; 4=often; and 5=always) with a range in score from 8 to 40 with higher scores indicating greater severity of sleep disturbance.
Outcome measures
| Measure |
tDCS With Mindfulness-based Meditation
n=15 Participants
Self Transcranial Direct Current Stimulation (tDCS) with Mindfulness-Based Meditation
Self Transcranial Direct Current Stimulation (tDCS): 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 (Soterix Medical Inc., New York; 6.5 inches long, 3 inches wide, 0.7 inches thick) with headgear and 5x7 cm saline-soaked surface sponge electrodes.
mindfulness-based meditation: The meditation intervention will be delivered by a recorded device that participants will be given together with the tDCS. All meditation instruction recordings will be done by an experienced mind-body intervention specialist and installed in a user-friendly MP3 player.
|
Sham tDCS With Sham Meditation
n=15 Participants
Sham self Transcranial Direct Current Stimulation (tDCS) with sham Meditation
Sham Self Transcranial Direct Current Stimulation (tDCS): 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.
sham meditation: For sham meditation, the participants will be instructed, approximately every 2-3 minutes, to take deep breaths as we sit in meditation. Time spent giving instructions in the sham meditation intervention will be matched to time spent in the mindfulness intervention.
|
|---|---|---|
|
Psychosocial Symptoms as Assessed by PROMIS Sleep Disturbance-short Form
|
18.27 score on a scale
Standard Deviation 4.43
|
21.13 score on a scale
Standard Deviation 7.06
|
SECONDARY outcome
Timeframe: baselineThe Pain Catastrophizing Scale (PCS) consists of 13 items assessing three components of catastrophizing: rumination, magnification, and helplessness. Each item rated on a 5-point scale: 0 (Not at all) to 4 (all the time).The PCS total score is computed by summing responses to all 13 items, with total scores ranging from 0 - 52. Higher scores indicate a worse outcome.
Outcome measures
| Measure |
tDCS With Mindfulness-based Meditation
n=15 Participants
Self Transcranial Direct Current Stimulation (tDCS) with Mindfulness-Based Meditation
Self Transcranial Direct Current Stimulation (tDCS): 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 (Soterix Medical Inc., New York; 6.5 inches long, 3 inches wide, 0.7 inches thick) with headgear and 5x7 cm saline-soaked surface sponge electrodes.
mindfulness-based meditation: The meditation intervention will be delivered by a recorded device that participants will be given together with the tDCS. All meditation instruction recordings will be done by an experienced mind-body intervention specialist and installed in a user-friendly MP3 player.
|
Sham tDCS With Sham Meditation
n=15 Participants
Sham self Transcranial Direct Current Stimulation (tDCS) with sham Meditation
Sham Self Transcranial Direct Current Stimulation (tDCS): 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.
sham meditation: For sham meditation, the participants will be instructed, approximately every 2-3 minutes, to take deep breaths as we sit in meditation. Time spent giving instructions in the sham meditation intervention will be matched to time spent in the mindfulness intervention.
|
|---|---|---|
|
Psychosocial Symptoms as Assessed by the Pain Catastrophizing Scale (PCS)
|
21.53 score on a scale
Standard Deviation 14.46
|
16.73 score on a scale
Standard Deviation 13.15
|
SECONDARY outcome
Timeframe: 2 weeksThe Pain Catastrophizing Scale (PCS) consists of 13 items assessing three components of catastrophizing: rumination, magnification, and helplessness. Each item rated on a 5-point scale: 0 (Not at all) to 4 (all the time).The PCS total score is computed by summing responses to all 13 items, with total scores ranging from 0 - 52. Higher scores indicate a worse outcome.
Outcome measures
| Measure |
tDCS With Mindfulness-based Meditation
n=15 Participants
Self Transcranial Direct Current Stimulation (tDCS) with Mindfulness-Based Meditation
Self Transcranial Direct Current Stimulation (tDCS): 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 (Soterix Medical Inc., New York; 6.5 inches long, 3 inches wide, 0.7 inches thick) with headgear and 5x7 cm saline-soaked surface sponge electrodes.
mindfulness-based meditation: The meditation intervention will be delivered by a recorded device that participants will be given together with the tDCS. All meditation instruction recordings will be done by an experienced mind-body intervention specialist and installed in a user-friendly MP3 player.
|
Sham tDCS With Sham Meditation
n=15 Participants
Sham self Transcranial Direct Current Stimulation (tDCS) with sham Meditation
Sham Self Transcranial Direct Current Stimulation (tDCS): 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.
sham meditation: For sham meditation, the participants will be instructed, approximately every 2-3 minutes, to take deep breaths as we sit in meditation. Time spent giving instructions in the sham meditation intervention will be matched to time spent in the mindfulness intervention.
|
|---|---|---|
|
Psychosocial Symptoms as Assessed by the Pain Catastrophizing Scale (PCS)
|
15.80 score on a scale
Standard Deviation 13.62
|
14.80 score on a scale
Standard Deviation 14.97
|
SECONDARY outcome
Timeframe: baselineThe Freiburg Mindfulness Inventory (FMI) is a 14-item instrument. Respondents indicate their experiences relating to the items on a 4-point Likert scale (rarely, occasionally, fairly often and almost always), and the total score is calculated by adding all the scores on the 14 items of the FMI. Total scores range from 14-56, with higher scores indicating higher levels of mindfulness.
Outcome measures
| Measure |
tDCS With Mindfulness-based Meditation
n=15 Participants
Self Transcranial Direct Current Stimulation (tDCS) with Mindfulness-Based Meditation
Self Transcranial Direct Current Stimulation (tDCS): 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 (Soterix Medical Inc., New York; 6.5 inches long, 3 inches wide, 0.7 inches thick) with headgear and 5x7 cm saline-soaked surface sponge electrodes.
mindfulness-based meditation: The meditation intervention will be delivered by a recorded device that participants will be given together with the tDCS. All meditation instruction recordings will be done by an experienced mind-body intervention specialist and installed in a user-friendly MP3 player.
|
Sham tDCS With Sham Meditation
n=15 Participants
Sham self Transcranial Direct Current Stimulation (tDCS) with sham Meditation
Sham Self Transcranial Direct Current Stimulation (tDCS): 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.
sham meditation: For sham meditation, the participants will be instructed, approximately every 2-3 minutes, to take deep breaths as we sit in meditation. Time spent giving instructions in the sham meditation intervention will be matched to time spent in the mindfulness intervention.
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|---|---|---|
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Psychosocial Symptoms as Assessed by the Freiburg Mindfulness Inventory (FMI)
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41.13 score on a scale
Standard Deviation 5.60
|
36.40 score on a scale
Standard Deviation 7.01
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SECONDARY outcome
Timeframe: 2 weeksThe Freiburg Mindfulness Inventory (FMI) is a 14-item instrument. Respondents indicate their experiences relating to the items on a 4-point Likert scale (rarely, occasionally, fairly often and almost always), and the total score is calculated by adding all the scores on the 14 items of the FMI. Total scores range from 14-56, with higher scores indicating higher levels of mindfulness.
Outcome measures
| Measure |
tDCS With Mindfulness-based Meditation
n=15 Participants
Self Transcranial Direct Current Stimulation (tDCS) with Mindfulness-Based Meditation
Self Transcranial Direct Current Stimulation (tDCS): 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 (Soterix Medical Inc., New York; 6.5 inches long, 3 inches wide, 0.7 inches thick) with headgear and 5x7 cm saline-soaked surface sponge electrodes.
mindfulness-based meditation: The meditation intervention will be delivered by a recorded device that participants will be given together with the tDCS. All meditation instruction recordings will be done by an experienced mind-body intervention specialist and installed in a user-friendly MP3 player.
|
Sham tDCS With Sham Meditation
n=15 Participants
Sham self Transcranial Direct Current Stimulation (tDCS) with sham Meditation
Sham Self Transcranial Direct Current Stimulation (tDCS): 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.
sham meditation: For sham meditation, the participants will be instructed, approximately every 2-3 minutes, to take deep breaths as we sit in meditation. Time spent giving instructions in the sham meditation intervention will be matched to time spent in the mindfulness intervention.
|
|---|---|---|
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Psychosocial Symptoms as Assessed by the Freiburg Mindfulness Inventory (FMI)
|
42.67 score on a scale
Standard Deviation 6.98
|
38.93 score on a scale
Standard Deviation 7.43
|
SECONDARY outcome
Timeframe: baseline, 2 weeksConditioned Pain Modulation (CPM) was assessed as the change in PPT on the trapezius immediately after the immersion of the contralateral hand up to the wrist in a cold-water bath (Neslab, Portsmouth, NH) at 12 degrees C for one minute. \[To assess PPT, a handheld digital pressure algometer (Wagner, Greenwich, CT) was applied at a constant rate of 0.3 kilograms force per centimeter squared (kgf/cm\^2) per second to the participant's trapezius. Participants were asked to notify the experimenter when the pressure sensation ''first becomes painful" to assess pressure pain threshold (PPT).\]
Outcome measures
| Measure |
tDCS With Mindfulness-based Meditation
n=15 Participants
Self Transcranial Direct Current Stimulation (tDCS) with Mindfulness-Based Meditation
Self Transcranial Direct Current Stimulation (tDCS): 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 (Soterix Medical Inc., New York; 6.5 inches long, 3 inches wide, 0.7 inches thick) with headgear and 5x7 cm saline-soaked surface sponge electrodes.
mindfulness-based meditation: The meditation intervention will be delivered by a recorded device that participants will be given together with the tDCS. All meditation instruction recordings will be done by an experienced mind-body intervention specialist and installed in a user-friendly MP3 player.
|
Sham tDCS With Sham Meditation
n=15 Participants
Sham self Transcranial Direct Current Stimulation (tDCS) with sham Meditation
Sham Self Transcranial Direct Current Stimulation (tDCS): 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.
sham meditation: For sham meditation, the participants will be instructed, approximately every 2-3 minutes, to take deep breaths as we sit in meditation. Time spent giving instructions in the sham meditation intervention will be matched to time spent in the mindfulness intervention.
|
|---|---|---|
|
Change in Experimental Pain Sensitivity as Assessed by Conditioned Pain Modulation
|
0.73 kilograms force (kgf)
Standard Deviation 1.31
|
-0.78 kilograms force (kgf)
Standard Deviation 1.17
|
SECONDARY outcome
Timeframe: baselinePain-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 pain stimulation.
Outcome measures
| Measure |
tDCS With Mindfulness-based Meditation
n=15 Participants
Self Transcranial Direct Current Stimulation (tDCS) with Mindfulness-Based Meditation
Self Transcranial Direct Current Stimulation (tDCS): 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 (Soterix Medical Inc., New York; 6.5 inches long, 3 inches wide, 0.7 inches thick) with headgear and 5x7 cm saline-soaked surface sponge electrodes.
mindfulness-based meditation: The meditation intervention will be delivered by a recorded device that participants will be given together with the tDCS. All meditation instruction recordings will be done by an experienced mind-body intervention specialist and installed in a user-friendly MP3 player.
|
Sham tDCS With Sham Meditation
n=15 Participants
Sham self Transcranial Direct Current Stimulation (tDCS) with sham Meditation
Sham Self Transcranial Direct Current Stimulation (tDCS): 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.
sham meditation: For sham meditation, the participants will be instructed, approximately every 2-3 minutes, to take deep breaths as we sit in meditation. Time spent giving instructions in the sham meditation intervention will be matched to time spent in the mindfulness intervention.
|
|---|---|---|
|
Number of Participants Who Were Assessed by Functional Near-infrared Spectroscopy (fNIRS)
|
15 Participants
|
15 Participants
|
SECONDARY outcome
Timeframe: 2 weeksPain-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 pain stimulation.
Outcome measures
| Measure |
tDCS With Mindfulness-based Meditation
n=15 Participants
Self Transcranial Direct Current Stimulation (tDCS) with Mindfulness-Based Meditation
Self Transcranial Direct Current Stimulation (tDCS): 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 (Soterix Medical Inc., New York; 6.5 inches long, 3 inches wide, 0.7 inches thick) with headgear and 5x7 cm saline-soaked surface sponge electrodes.
mindfulness-based meditation: The meditation intervention will be delivered by a recorded device that participants will be given together with the tDCS. All meditation instruction recordings will be done by an experienced mind-body intervention specialist and installed in a user-friendly MP3 player.
|
Sham tDCS With Sham Meditation
n=15 Participants
Sham self Transcranial Direct Current Stimulation (tDCS) with sham Meditation
Sham Self Transcranial Direct Current Stimulation (tDCS): 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.
sham meditation: For sham meditation, the participants will be instructed, approximately every 2-3 minutes, to take deep breaths as we sit in meditation. Time spent giving instructions in the sham meditation intervention will be matched to time spent in the mindfulness intervention.
|
|---|---|---|
|
Number of Participants Who Were Assessed by Functional Near-infrared Spectroscopy
|
15 Participants
|
15 Participants
|
SECONDARY outcome
Timeframe: baseline, 2 weeksParticipants immersed their hand in a cold water bath, and at thirty seconds after hand immersion, they rated the cold pain intensity on a scale of 0-100. A higher score indicating higher pain intensity.
Outcome measures
| Measure |
tDCS With Mindfulness-based Meditation
n=15 Participants
Self Transcranial Direct Current Stimulation (tDCS) with Mindfulness-Based Meditation
Self Transcranial Direct Current Stimulation (tDCS): 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 (Soterix Medical Inc., New York; 6.5 inches long, 3 inches wide, 0.7 inches thick) with headgear and 5x7 cm saline-soaked surface sponge electrodes.
mindfulness-based meditation: The meditation intervention will be delivered by a recorded device that participants will be given together with the tDCS. All meditation instruction recordings will be done by an experienced mind-body intervention specialist and installed in a user-friendly MP3 player.
|
Sham tDCS With Sham Meditation
n=15 Participants
Sham self Transcranial Direct Current Stimulation (tDCS) with sham Meditation
Sham Self Transcranial Direct Current Stimulation (tDCS): 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.
sham meditation: For sham meditation, the participants will be instructed, approximately every 2-3 minutes, to take deep breaths as we sit in meditation. Time spent giving instructions in the sham meditation intervention will be matched to time spent in the mindfulness intervention.
|
|---|---|---|
|
Change in Experimental Pain Sensitivity as Assessed by Cold Pain Intensity
|
-15.33 score on a scale
Standard Deviation 22.40
|
9.67 score on a scale
Standard Deviation 19.32
|
SECONDARY outcome
Timeframe: baseline, 2 weeksTo assess pressure pain threshold (PPT), a handheld digital pressure algometer (Wagner, Greenwich, CT) was applied at a constant rate of 0.3 kilograms force per centimeter squared (kgf/cm\^2) per second to the participant's knee. Participants were asked to notify the experimenter when the pressure sensation ''first becomes painful" to assess pressure pain threshold (PPT).
Outcome measures
| Measure |
tDCS With Mindfulness-based Meditation
n=15 Participants
Self Transcranial Direct Current Stimulation (tDCS) with Mindfulness-Based Meditation
Self Transcranial Direct Current Stimulation (tDCS): 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 (Soterix Medical Inc., New York; 6.5 inches long, 3 inches wide, 0.7 inches thick) with headgear and 5x7 cm saline-soaked surface sponge electrodes.
mindfulness-based meditation: The meditation intervention will be delivered by a recorded device that participants will be given together with the tDCS. All meditation instruction recordings will be done by an experienced mind-body intervention specialist and installed in a user-friendly MP3 player.
|
Sham tDCS With Sham Meditation
n=15 Participants
Sham self Transcranial Direct Current Stimulation (tDCS) with sham Meditation
Sham Self Transcranial Direct Current Stimulation (tDCS): 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.
sham meditation: For sham meditation, the participants will be instructed, approximately every 2-3 minutes, to take deep breaths as we sit in meditation. Time spent giving instructions in the sham meditation intervention will be matched to time spent in the mindfulness intervention.
|
|---|---|---|
|
Change in Experimental Pain Sensitivity as Assessed by Pressure Pain Threshold, Lateral Knee
|
.75 kilograms force (kgf)
Standard Deviation 1.29
|
-.71 kilograms force (kgf)
Standard Deviation 0.82
|
SECONDARY outcome
Timeframe: baseline, 2 weeksTo assess pressure pain threshold (PPT), a handheld digital pressure algometer (Wagner, Greenwich, CT) was applied at a constant rate of 0.3 kilograms force per centimeter squared (kgf/cm\^2) per second to the participant's knee. Participants were asked to notify the experimenter when the pressure sensation ''first becomes painful" to assess pressure pain threshold (PPT).
Outcome measures
| Measure |
tDCS With Mindfulness-based Meditation
n=15 Participants
Self Transcranial Direct Current Stimulation (tDCS) with Mindfulness-Based Meditation
Self Transcranial Direct Current Stimulation (tDCS): 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 (Soterix Medical Inc., New York; 6.5 inches long, 3 inches wide, 0.7 inches thick) with headgear and 5x7 cm saline-soaked surface sponge electrodes.
mindfulness-based meditation: The meditation intervention will be delivered by a recorded device that participants will be given together with the tDCS. All meditation instruction recordings will be done by an experienced mind-body intervention specialist and installed in a user-friendly MP3 player.
|
Sham tDCS With Sham Meditation
n=15 Participants
Sham self Transcranial Direct Current Stimulation (tDCS) with sham Meditation
Sham Self Transcranial Direct Current Stimulation (tDCS): 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.
sham meditation: For sham meditation, the participants will be instructed, approximately every 2-3 minutes, to take deep breaths as we sit in meditation. Time spent giving instructions in the sham meditation intervention will be matched to time spent in the mindfulness intervention.
|
|---|---|---|
|
Change in Experimental Pain Sensitivity as Assessed by Pressure Pain Threshold, Medial Knee
|
.69 kilograms force (kgf)
Standard Deviation 1.16
|
-.79 kilograms force (kgf)
Standard Deviation .58
|
Adverse Events
tDCS With Mindfulness-based Meditation
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Sham tDCS With Sham Meditation
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Hyochol Ahn, PhD, MSN, MS-ECE, MS-CTS, APRN, ANP-BC, FAAN
Florida State University
Phone: 850-644-2647
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place