Trial Outcomes & Findings for Self Cranial Electrical Stimulation (CES) for Pain in Older Adults With Knee Osteoarthritis (Self CES for Knee Pain) (NCT NCT04016259)
NCT ID: NCT04016259
Last Updated: 2020-11-16
Results Overview
The NRS total score ranges from 0 (no pain) to 100 (most intense pain imaginable).
COMPLETED
NA
30 participants
week 2
2020-11-16
Participant Flow
Participant milestones
| Measure |
Sham-CES
Sham-CES: For sham CES, the electrodes will be identical look and be placed in the same positions as for active stimulation, but the stimulator will not deliver electrical current.
|
Self-CES
Cranial Electrical Stimulation (CES): CES will be applied for 60 minutes per session daily for 2 weeks (Monday to Friday) via the Alpha-Stim M Electromedical Products International, Inc., Mineral Wells, TX).
|
|---|---|---|
|
Overall Study
STARTED
|
15
|
15
|
|
Overall Study
COMPLETED
|
15
|
15
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Self Cranial Electrical Stimulation (CES) for Pain in Older Adults With Knee Osteoarthritis (Self CES for Knee Pain)
Baseline characteristics by cohort
| Measure |
Sham-CES
n=15 Participants
Sham-CES: For sham CES, the electrodes will be identical look and be placed in the same positions as for active stimulation, but the stimulator will not deliver electrical current.
|
Self-CES
n=15 Participants
Cranial Electrical Stimulation (CES): CES will be applied for 60 minutes per session daily for 2 weeks (Monday to Friday) via the Alpha-Stim M Electromedical Products International, Inc., Mineral Wells, TX).
|
Total
n=30 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
59.13 years
STANDARD_DEVIATION 5.83 • n=5 Participants
|
59.77 years
STANDARD_DEVIATION 6.88 • n=7 Participants
|
59.43 years
STANDARD_DEVIATION 6.27 • n=5 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
7 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
African American
|
5 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 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
|
5 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Education
2-Year College
|
1 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Education
4-Year College
|
5 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Education
Master's Degree
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Education
Doctoral Degree
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Duration of Osteoarthritis
|
55.87 months
STANDARD_DEVIATION 40.64 • n=5 Participants
|
108 months
STANDARD_DEVIATION 103.87 • n=7 Participants
|
81.03 months
STANDARD_DEVIATION 80.86 • n=5 Participants
|
|
Body Mass Index (BMI)
|
33.66 kg/m^2
STANDARD_DEVIATION 8.33 • n=5 Participants
|
32.56 kg/m^2
STANDARD_DEVIATION 8.17 • n=7 Participants
|
33.11 kg/m^2
STANDARD_DEVIATION 8.13 • n=5 Participants
|
|
Pain as Assessed by a Numerical Rating Scale (NRS)
|
34.67 units on a scale
STANDARD_DEVIATION 32.48 • n=5 Participants
|
44.33 units on a scale
STANDARD_DEVIATION 19.90 • n=7 Participants
|
39.50 units on a scale
STANDARD_DEVIATION 26.92 • n=5 Participants
|
|
Clinical pain assessed by the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
|
52.67 score on a scale
STANDARD_DEVIATION 21.413 • n=5 Participants
|
52.20 score on a scale
STANDARD_DEVIATION 17.604 • n=7 Participants
|
52.44 score on a scale
STANDARD_DEVIATION 19.5085 • n=5 Participants
|
|
Experimental Pain Sensitivity as measured by heat pain threshold (HPTH)
|
40.12 degree Celsius
STANDARD_DEVIATION 2.69 • n=5 Participants
|
38.34 degree Celsius
STANDARD_DEVIATION 3.44 • n=7 Participants
|
39.23 degree Celsius
STANDARD_DEVIATION 3.16 • n=5 Participants
|
|
Experimental Pain Sensitivity as measured by heat pain tolerance (HPTO)
|
43.85 degree Celsius
STANDARD_DEVIATION 3.26 • n=5 Participants
|
43.22 degree Celsius
STANDARD_DEVIATION 3.15 • n=7 Participants
|
43.54 degree Celsius
STANDARD_DEVIATION 3.16 • n=5 Participants
|
|
Experimental Pain Sensitivity as measured by pressure pain threshold (PPT)
|
1.86 kilogram-force (kgf)
STANDARD_DEVIATION 1.32 • n=5 Participants
|
1.60 kilogram-force (kgf)
STANDARD_DEVIATION 0.95 • n=7 Participants
|
1.73 kilogram-force (kgf)
STANDARD_DEVIATION 1.14 • n=5 Participants
|
|
Experimental Pain Sensitivity as measured by Conditioned Pain Modulation (CPM)
|
2.70 kilogram-force (kgf)
STANDARD_DEVIATION 1.26 • n=5 Participants
|
2.53 kilogram-force (kgf)
STANDARD_DEVIATION 0.86 • n=7 Participants
|
2.61 kilogram-force (kgf)
STANDARD_DEVIATION 1.06 • n=5 Participants
|
|
Psychosocial symptoms measured by the Patient-Reported Outcomes Measurement Info System - anxiety
|
15.67 score on a scale
STANDARD_DEVIATION 8.723 • n=5 Participants
|
12.27 score on a scale
STANDARD_DEVIATION 4.200 • n=7 Participants
|
13.97 score on a scale
STANDARD_DEVIATION 6.4615 • n=5 Participants
|
|
Psychosocial symptoms as measured by PROMIS - depression
|
12.73 score on a scale
STANDARD_DEVIATION 5.351 • n=5 Participants
|
10.53 score on a scale
STANDARD_DEVIATION 2.446 • n=7 Participants
|
11.63 score on a scale
STANDARD_DEVIATION 3.8985 • n=5 Participants
|
|
Psychosocial symptoms as measured by PROMIS - sleep disturbance
|
27.47 score on a scale
STANDARD_DEVIATION 7.029 • n=5 Participants
|
22.20 score on a scale
STANDARD_DEVIATION 8.187 • n=7 Participants
|
24.835 score on a scale
STANDARD_DEVIATION 7.608 • n=5 Participants
|
|
Psychosocial symptoms as measured by the Pain Catastrophizing Scale (PCS)
|
18.40 score on a scale
STANDARD_DEVIATION 14.495 • n=5 Participants
|
13.80 score on a scale
STANDARD_DEVIATION 10.065 • n=7 Participants
|
16.10 score on a scale
STANDARD_DEVIATION 12.280 • n=5 Participants
|
PRIMARY outcome
Timeframe: week 2The NRS total score ranges from 0 (no pain) to 100 (most intense pain imaginable).
Outcome measures
| Measure |
Sham-CES
n=15 Participants
Sham-CES: For sham CES, the electrodes will be identical look and be placed in the same positions as for active stimulation, but the stimulator will not deliver electrical current.
|
Self-CES
n=15 Participants
Cranial Electrical Stimulation (CES): CES will be applied for 60 minutes per session daily for 2 weeks (Monday to Friday) via the Alpha-Stim M Electromedical Products International, Inc., Mineral Wells, TX).
|
|---|---|---|
|
Clinical Pain as Assessed by a Numeric Rating Scale (NRS) for Pain
|
40.40 units on a scale
Standard Deviation 33.79
|
27.33 units on a scale
Standard Deviation 16.89
|
PRIMARY outcome
Timeframe: week 2The WOMAC ranges from 0 to 96, with higher scores indicating worse osteoarthritis (OA) pain-related symptoms
Outcome measures
| Measure |
Sham-CES
n=15 Participants
Sham-CES: For sham CES, the electrodes will be identical look and be placed in the same positions as for active stimulation, but the stimulator will not deliver electrical current.
|
Self-CES
n=15 Participants
Cranial Electrical Stimulation (CES): CES will be applied for 60 minutes per session daily for 2 weeks (Monday to Friday) via the Alpha-Stim M Electromedical Products International, Inc., Mineral Wells, TX).
|
|---|---|---|
|
Clinical Pain as Assessed by the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
|
47.40 score on a scale
Standard Deviation 25.136
|
43.80 score on a scale
Standard Deviation 18.040
|
SECONDARY outcome
Timeframe: week 2In order to measure experimental pain sensitivity, a multimodal Quantitative Sensory Testing (QST) battery will be completed: heat pain threshold (HPTH), heat pain tolerance (HPTO), pressure pain threshold (PPT), and Conditioned Pain Modulation (CPM). To assess HPTH, heat stimuli were delivered to the participant's knee using a computer-controlled TSAII NeuroSensory Analyzer. From a baseline of 32 degrees Celsius, the temperature increased by 0.5 degrees Celsius per second until the participants responded by pressing a button to stop heat stimuli. Participants were instructed to press the button when the sensation ''first becomes painful" to assess the heat pain threshold (HPTH).
Outcome measures
| Measure |
Sham-CES
n=15 Participants
Sham-CES: For sham CES, the electrodes will be identical look and be placed in the same positions as for active stimulation, but the stimulator will not deliver electrical current.
|
Self-CES
n=15 Participants
Cranial Electrical Stimulation (CES): CES will be applied for 60 minutes per session daily for 2 weeks (Monday to Friday) via the Alpha-Stim M Electromedical Products International, Inc., Mineral Wells, TX).
|
|---|---|---|
|
Experimental Pain Sensitivity as Measured Using a Multimodal Quantitative Sensory Testing (QST) Battery - Heat Pain Threshold (HPTH)
|
37.90 degree Celsius
Standard Deviation 2.03
|
41.04 degree Celsius
Standard Deviation 3.17
|
SECONDARY outcome
Timeframe: week 2In order to measure experimental pain sensitivity, a multimodal Quantitative Sensory Testing (QST) battery will be completed: heat pain threshold (HPTH), heat pain tolerance (HPTO), pressure pain threshold (PPT), and Conditioned Pain Modulation (CPM). To assess HPTO, heat stimuli were delivered to the participant's knee using a computer-controlled TSAII NeuroSensory Analyzer. From a baseline of 32 degrees Celsius, the temperature increased by 0.5 degrees Celsius per second until the participants responded by pressing a button to stop heat stimuli. Participants were instructed to press the button when they ''no longer feel able to tolerate the pain" to assess their heat pain tolerance (HPTO).
Outcome measures
| Measure |
Sham-CES
n=15 Participants
Sham-CES: For sham CES, the electrodes will be identical look and be placed in the same positions as for active stimulation, but the stimulator will not deliver electrical current.
|
Self-CES
n=15 Participants
Cranial Electrical Stimulation (CES): CES will be applied for 60 minutes per session daily for 2 weeks (Monday to Friday) via the Alpha-Stim M Electromedical Products International, Inc., Mineral Wells, TX).
|
|---|---|---|
|
Experimental Pain Sensitivity as Measured Using a Multimodal Quantitative Sensory Testing (QST) Battery - Heat Pain Tolerance (HPTO)
|
43.05 degree Celsius
Standard Deviation 2.77
|
44.56 degree Celsius
Standard Deviation 3.12
|
SECONDARY outcome
Timeframe: week 2In order to measure experimental pain sensitivity, a multimodal Quantitative Sensory Testing (QST) battery will be completed: heat pain threshold (HPTH), heat pain tolerance (HPTO), pressure pain threshold (PPT), and Conditioned Pain Modulation (CPM). 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 knee. Participants were asked to notify the experimenter when the pressure sensation ''first becomes painful" to assess pressure pain threshold (PPT).
Outcome measures
| Measure |
Sham-CES
n=15 Participants
Sham-CES: For sham CES, the electrodes will be identical look and be placed in the same positions as for active stimulation, but the stimulator will not deliver electrical current.
|
Self-CES
n=15 Participants
Cranial Electrical Stimulation (CES): CES will be applied for 60 minutes per session daily for 2 weeks (Monday to Friday) via the Alpha-Stim M Electromedical Products International, Inc., Mineral Wells, TX).
|
|---|---|---|
|
Experimental Pain Sensitivity as Measured Using a Multimodal Quantitative Sensory Testing (QST) Battery - Pressure Pain Threshold (PPT)
|
1.06 kilograms force (kgf)
Standard Deviation 0.48
|
2.59 kilograms force (kgf)
Standard Deviation 1.46
|
SECONDARY outcome
Timeframe: week 2In order to measure experimental pain sensitivity, a multimodal Quantitative Sensory Testing (QST) battery will be completed: heat pain threshold (HPTH), heat pain tolerance (HPTO), pressure pain threshold (PPT), and Conditioned Pain Modulation (CPM). 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 |
Sham-CES
n=15 Participants
Sham-CES: For sham CES, the electrodes will be identical look and be placed in the same positions as for active stimulation, but the stimulator will not deliver electrical current.
|
Self-CES
n=15 Participants
Cranial Electrical Stimulation (CES): CES will be applied for 60 minutes per session daily for 2 weeks (Monday to Friday) via the Alpha-Stim M Electromedical Products International, Inc., Mineral Wells, TX).
|
|---|---|---|
|
Experimental Pain Sensitivity as Measured Using a Multimodal Quantitative Sensory Testing (QST) Battery - Conditioned Pain Modulation (CPM)
|
1.93 kilograms force (kgf)
Standard Deviation 0.90
|
3.64 kilograms force (kgf)
Standard Deviation 1.67
|
SECONDARY outcome
Timeframe: week 2The 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 |
Sham-CES
n=15 Participants
Sham-CES: For sham CES, the electrodes will be identical look and be placed in the same positions as for active stimulation, but the stimulator will not deliver electrical current.
|
Self-CES
n=15 Participants
Cranial Electrical Stimulation (CES): CES will be applied for 60 minutes per session daily for 2 weeks (Monday to Friday) via the Alpha-Stim M Electromedical Products International, Inc., Mineral Wells, TX).
|
|---|---|---|
|
Psychosocial Symptoms as Measured by the Patient-Reported Outcomes Measurement Information System (PROMIS) - Anxiety Short Form
|
15.13 score on a scale
Standard Deviation 6.770
|
13.20 score on a scale
Standard Deviation 4.663
|
SECONDARY outcome
Timeframe: week 2The 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 |
Sham-CES
n=15 Participants
Sham-CES: For sham CES, the electrodes will be identical look and be placed in the same positions as for active stimulation, but the stimulator will not deliver electrical current.
|
Self-CES
n=15 Participants
Cranial Electrical Stimulation (CES): CES will be applied for 60 minutes per session daily for 2 weeks (Monday to Friday) via the Alpha-Stim M Electromedical Products International, Inc., Mineral Wells, TX).
|
|---|---|---|
|
Psychosocial Symptoms as Measured by PROMIS - Depression Short Form
|
13.13 score on a scale
Standard Deviation 5.449
|
10.87 score on a scale
Standard Deviation 2.642
|
SECONDARY outcome
Timeframe: week 2The 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 |
Sham-CES
n=15 Participants
Sham-CES: For sham CES, the electrodes will be identical look and be placed in the same positions as for active stimulation, but the stimulator will not deliver electrical current.
|
Self-CES
n=15 Participants
Cranial Electrical Stimulation (CES): CES will be applied for 60 minutes per session daily for 2 weeks (Monday to Friday) via the Alpha-Stim M Electromedical Products International, Inc., Mineral Wells, TX).
|
|---|---|---|
|
Psychosocial Symptoms as Measured by PROMIS - Sleep Disturbance Short Form
|
24.60 score on a scale
Standard Deviation 6.566
|
22.27 score on a scale
Standard Deviation 7.126
|
SECONDARY outcome
Timeframe: week 2The Pain Catastrophizing Scale (PCS) consists of 13 items assessing three components of catastrophizing: rumination, magnification, and helplessness. It is measured using the 0 (not at all) to 4 (all the time) scale. Total score ranges from 0 to 52, with higher scores indicating greater pain catastrophizing.
Outcome measures
| Measure |
Sham-CES
n=15 Participants
Sham-CES: For sham CES, the electrodes will be identical look and be placed in the same positions as for active stimulation, but the stimulator will not deliver electrical current.
|
Self-CES
n=15 Participants
Cranial Electrical Stimulation (CES): CES will be applied for 60 minutes per session daily for 2 weeks (Monday to Friday) via the Alpha-Stim M Electromedical Products International, Inc., Mineral Wells, TX).
|
|---|---|---|
|
Psychosocial Symptoms as Measured by the Pain Catastrophizing Scale (PCS)
|
15.87 score on a scale
Standard Deviation 15.505
|
14.47 score on a scale
Standard Deviation 10.789
|
SECONDARY outcome
Timeframe: baseline, week 2Pain-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 |
Sham-CES
n=15 Participants
Sham-CES: For sham CES, the electrodes will be identical look and be placed in the same positions as for active stimulation, but the stimulator will not deliver electrical current.
|
Self-CES
n=15 Participants
Cranial Electrical Stimulation (CES): CES will be applied for 60 minutes per session daily for 2 weeks (Monday to Friday) via the Alpha-Stim M Electromedical Products International, Inc., Mineral Wells, TX).
|
|---|---|---|
|
Number of Participants With a Significant Change in Pain-related Cortical Response on Average as Assessed by a Continuous Wave, Multichannel Functional Near-infrared Spectroscopy (fNIRS) Imaging System
|
0 Participants
|
15 Participants
|
SECONDARY outcome
Timeframe: week 2The CSQ-8 comprises eight items that are summed to yield an overall score of 8-32, with higher scores indicating greater satisfaction.
Outcome measures
| Measure |
Sham-CES
n=15 Participants
Sham-CES: For sham CES, the electrodes will be identical look and be placed in the same positions as for active stimulation, but the stimulator will not deliver electrical current.
|
Self-CES
n=15 Participants
Cranial Electrical Stimulation (CES): CES will be applied for 60 minutes per session daily for 2 weeks (Monday to Friday) via the Alpha-Stim M Electromedical Products International, Inc., Mineral Wells, TX).
|
|---|---|---|
|
Participant Satisfaction With Treatment Using the Client Satisfaction Questionnaire (CSQ-8)
|
29.53 score on a scale
Standard Deviation 2.264
|
27.20 score on a scale
Standard Deviation 4.843
|
SECONDARY outcome
Timeframe: week 2Outcome measures
| Measure |
Sham-CES
n=15 Participants
Sham-CES: For sham CES, the electrodes will be identical look and be placed in the same positions as for active stimulation, but the stimulator will not deliver electrical current.
|
Self-CES
n=15 Participants
Cranial Electrical Stimulation (CES): CES will be applied for 60 minutes per session daily for 2 weeks (Monday to Friday) via the Alpha-Stim M Electromedical Products International, Inc., Mineral Wells, TX).
|
|---|---|---|
|
Feasibility as Measured by the Number of Participants That Completed the Full CES Protocol
|
15 Participants
|
15 Participants
|
SECONDARY outcome
Timeframe: week 2CES experience will be measured on a 10-item scale, with each item rated 0-10 and 0 being strongly disagree and 10 being strongly agree. Total score ranges from 0 to 100, with higher scores indicating a better CES experience. Question 1. It was easy to prepare the device and accessories Question 2. The device was unnecessarily complex Question 3. The device was easy to use Question 4. I felt the video conferences with a technical person were helpful Question 5. I would imagine that most people would learn to use this device quickly Question 6. The device was cumbersome to use Question 7. I felt confident using the device Question 8. I needed to learn a lot of things before I could get going with this device Question 9. The effectiveness of the treatment increased over the course of treatment Question 10. I felt that transcranial electrical stimulation treatment benefited me
Outcome measures
| Measure |
Sham-CES
n=15 Participants
Sham-CES: For sham CES, the electrodes will be identical look and be placed in the same positions as for active stimulation, but the stimulator will not deliver electrical current.
|
Self-CES
n=15 Participants
Cranial Electrical Stimulation (CES): CES will be applied for 60 minutes per session daily for 2 weeks (Monday to Friday) via the Alpha-Stim M Electromedical Products International, Inc., Mineral Wells, TX).
|
|---|---|---|
|
Feasibility as Indicated by Participant's Cranial Electrical Stimulation (CES) Experience
Question 1
|
9.80 units on a scale
Standard Deviation 0.56
|
9.93 units on a scale
Standard Deviation 0.26
|
|
Feasibility as Indicated by Participant's Cranial Electrical Stimulation (CES) Experience
Question 2
|
0.00 units on a scale
Standard Deviation 0.00
|
0.00 units on a scale
Standard Deviation 0.00
|
|
Feasibility as Indicated by Participant's Cranial Electrical Stimulation (CES) Experience
Question 3
|
9.93 units on a scale
Standard Deviation 0.29
|
10.00 units on a scale
Standard Deviation 0.00
|
|
Feasibility as Indicated by Participant's Cranial Electrical Stimulation (CES) Experience
Question 4
|
8.73 units on a scale
Standard Deviation 2.55
|
9.27 units on a scale
Standard Deviation 1.94
|
|
Feasibility as Indicated by Participant's Cranial Electrical Stimulation (CES) Experience
Question 5
|
9.67 units on a scale
Standard Deviation 0.62
|
9.87 units on a scale
Standard Deviation 0.52
|
|
Feasibility as Indicated by Participant's Cranial Electrical Stimulation (CES) Experience
Question 6
|
0.27 units on a scale
Standard Deviation 0.70
|
0.07 units on a scale
Standard Deviation 0.26
|
|
Feasibility as Indicated by Participant's Cranial Electrical Stimulation (CES) Experience
Question 7
|
9.67 units on a scale
Standard Deviation 1.29
|
10.00 units on a scale
Standard Deviation 0.00
|
|
Feasibility as Indicated by Participant's Cranial Electrical Stimulation (CES) Experience
Question 8
|
0.53 units on a scale
Standard Deviation 1.36
|
0.20 units on a scale
Standard Deviation 0.56
|
|
Feasibility as Indicated by Participant's Cranial Electrical Stimulation (CES) Experience
Question 9
|
6.47 units on a scale
Standard Deviation 3.50
|
5.67 units on a scale
Standard Deviation 4.35
|
|
Feasibility as Indicated by Participant's Cranial Electrical Stimulation (CES) Experience
Question 10
|
5.80 units on a scale
Standard Deviation 3.55
|
6.33 units on a scale
Standard Deviation 4.10
|
SECONDARY outcome
Timeframe: week 2Measurement of presence and severity of possible side effects of treatment on a 0 (not at all) to 10 (highest degree) scale.If any side effects are reported, the degree of relatedness to the intervention will be assessed on a 5-point scale.
Outcome measures
| Measure |
Sham-CES
n=15 Participants
Sham-CES: For sham CES, the electrodes will be identical look and be placed in the same positions as for active stimulation, but the stimulator will not deliver electrical current.
|
Self-CES
n=15 Participants
Cranial Electrical Stimulation (CES): CES will be applied for 60 minutes per session daily for 2 weeks (Monday to Friday) via the Alpha-Stim M Electromedical Products International, Inc., Mineral Wells, TX).
|
|---|---|---|
|
Tolerability as Indicated by Number of Participants With Possible Side Effects of Treatment
|
0 Participants
|
0 Participants
|
Adverse Events
Sham-CES
Self-CES
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Hyochol "Brian" Ahn, PhD, RN, MSN, Associate Professor
The University of Texas Health Science Center at Houston
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place