Trial Outcomes & Findings for Home-based tDCS and Mindfulness-based Meditation for Self-management of Clinical Pain and Symptoms (NCT NCT04375072)
NCT ID: NCT04375072
Last Updated: 2025-11-12
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
208 participants
Primary outcome timeframe
baseline, week 2 (after 10 tDCS sessions)
Results posted on
2025-11-12
Participant Flow
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.
Participant milestones
| Measure |
active tDCS paired with active MBM
A 2mA current and mindfulness-based meditation are applied for 20 minutes
|
sham tDCS paired with active MBM
A 2mA current is applied for 30 seconds, and mindfulness-based meditation is conducted for 20 minutes.
|
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.
|
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.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
53
|
53
|
50
|
52
|
|
Overall Study
COMPLETED
|
50
|
50
|
50
|
50
|
|
Overall Study
NOT COMPLETED
|
3
|
3
|
0
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Home-based tDCS and Mindfulness-based Meditation for Self-management of Clinical Pain and Symptoms
Baseline characteristics by cohort
| Measure |
Active tDCS Paired With Active MBM,
n=53 Participants
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.
|
Sham tDCS Paired With Active MBM
n=53 Participants
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.
|
Active tDCS Paired With Sham MBM
n=50 Participants
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.
|
Sham tDCS Paired With Sham MBM
n=52 Participants
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.
|
Total
n=208 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=10 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=45 Participants
|
0 Participants
n=44 Participants
|
|
Age, Continuous
|
66.49 years
STANDARD_DEVIATION 7.74 • n=10 Participants
|
67.19 years
STANDARD_DEVIATION 7.89 • n=10 Participants
|
68.06 years
STANDARD_DEVIATION 7.42 • n=20 Participants
|
68.88 years
STANDARD_DEVIATION 6.92 • n=45 Participants
|
67.6 years
STANDARD_DEVIATION 7.5 • n=44 Participants
|
|
Sex: Female, Male
Female
|
34 Participants
n=10 Participants
|
40 Participants
n=10 Participants
|
34 Participants
n=20 Participants
|
34 Participants
n=45 Participants
|
142 Participants
n=44 Participants
|
|
Sex: Female, Male
Male
|
19 Participants
n=10 Participants
|
13 Participants
n=10 Participants
|
16 Participants
n=20 Participants
|
18 Participants
n=45 Participants
|
66 Participants
n=44 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=10 Participants
|
3 Participants
n=10 Participants
|
4 Participants
n=20 Participants
|
2 Participants
n=45 Participants
|
11 Participants
n=44 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
51 Participants
n=10 Participants
|
50 Participants
n=10 Participants
|
46 Participants
n=20 Participants
|
50 Participants
n=45 Participants
|
197 Participants
n=44 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=10 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=45 Participants
|
0 Participants
n=44 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=10 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=45 Participants
|
0 Participants
n=44 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=10 Participants
|
5 Participants
n=10 Participants
|
0 Participants
n=20 Participants
|
1 Participants
n=45 Participants
|
6 Participants
n=44 Participants
|
|
Race (NIH/OMB)
Black or African American
|
7 Participants
n=10 Participants
|
4 Participants
n=10 Participants
|
3 Participants
n=20 Participants
|
6 Participants
n=45 Participants
|
20 Participants
n=44 Participants
|
|
Race (NIH/OMB)
White
|
44 Participants
n=10 Participants
|
41 Participants
n=10 Participants
|
43 Participants
n=20 Participants
|
43 Participants
n=45 Participants
|
171 Participants
n=44 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=10 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=45 Participants
|
0 Participants
n=44 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=10 Participants
|
3 Participants
n=10 Participants
|
4 Participants
n=20 Participants
|
2 Participants
n=45 Participants
|
11 Participants
n=44 Participants
|
PRIMARY outcome
Timeframe: baseline, week 2 (after 10 tDCS sessions)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.
Outcome measures
| Measure |
active tDCS paired with sham MBM
n=50 Participants
A 2mA current is applied for 20 minutes, and mindfulness-based meditation without the specific instructions is conducted for 20 minutes.
|
sham tDCS paired with sham MBM
n=52 Participants
A 2mA current is applied for 30 seconds, and mindfulness-based meditation without the specific instructions is conducted for 20 minutes.
|
active tDCS paired with active MBM
n=53 Participants
A 2mA current and mindfulness-based meditation are applied for 20 minutes
|
sham tDCS paired with active MBM
n=53 Participants
A 2mA current is applied for 30 seconds, and mindfulness-based meditation is conducted for 20 minutes.
|
|---|---|---|---|---|
|
Change in Numeric Rating Score (NRS) of Pain
|
-16.78 units on a scale
Standard Deviation 17.90
|
-6.20 units on a scale
Standard Deviation 17.99
|
-19.41 units on a scale
Standard Deviation 19.76
|
-7.16 units on a scale
Standard Deviation 22.24
|
SECONDARY outcome
Timeframe: baseline, week 2 (after 10 tDCS sessions)Population: Comparison of WOMAC score changes between four groups at 2 weeks from baseline.
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.
Outcome measures
| Measure |
active tDCS paired with sham MBM
n=50 Participants
A 2mA current is applied for 20 minutes, and mindfulness-based meditation without the specific instructions is conducted for 20 minutes.
|
sham tDCS paired with sham MBM
n=52 Participants
A 2mA current is applied for 30 seconds, and mindfulness-based meditation without the specific instructions is conducted for 20 minutes.
|
active tDCS paired with active MBM
n=53 Participants
A 2mA current and mindfulness-based meditation are applied for 20 minutes
|
sham tDCS paired with active MBM
n=53 Participants
A 2mA current is applied for 30 seconds, and mindfulness-based meditation is conducted for 20 minutes.
|
|---|---|---|---|---|
|
Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC).
|
-8.08 units on a scale
Standard Deviation 13.39
|
-4.50 units on a scale
Standard Deviation 11.33
|
-6.98 units on a scale
Standard Deviation 13.27
|
-7.90 units on a scale
Standard Deviation 14.20
|
Adverse Events
active tDCS paired with active MBM,
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
sham tDCS paired with active MBM
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
active tDCS paired with sham MBM
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
sham tDCS paired with sham MBM
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place