Trial Outcomes & Findings for Transcranial Alternating Current Stimulation in Back Pain- Pilot Sudy (NCT NCT03243084)
NCT ID: NCT03243084
Last Updated: 2018-12-12
Results Overview
Changes in parasympathetic tone, increase in high frequency band input via spectral analysis on EKG recordings between active and sham stimulation
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
21 participants
Primary outcome timeframe
before and after 40-minute stimulation at each session
Results posted on
2018-12-12
Participant Flow
Recruitment ran from August 2017 - December 2017. This clinical trial utilized multiple recruitment strategies including UNC University Physical Therapy and Pain clinic locations, informational notify.unc.edu system, and jointheconquest.org along with the listing on clinicaltrials.gov
Participant milestones
| Measure |
Sham Then Active 10 Hz tACS
At session 1 this group received sham tACS and at session 2 they received active 10Hz tACS
|
Active 10 Hz Then Sham tACS
At session 1 this group received active 10Hz tACS and at session 2 they received sham tACS
|
|---|---|---|
|
Session 1
STARTED
|
11
|
10
|
|
Session 1
COMPLETED
|
11
|
10
|
|
Session 1
NOT COMPLETED
|
0
|
0
|
|
Washout (1-3 Weeks)
STARTED
|
11
|
10
|
|
Washout (1-3 Weeks)
COMPLETED
|
10
|
10
|
|
Washout (1-3 Weeks)
NOT COMPLETED
|
1
|
0
|
|
Session 2
STARTED
|
10
|
10
|
|
Session 2
COMPLETED
|
10
|
10
|
|
Session 2
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
| Measure |
Sham Then Active 10 Hz tACS
At session 1 this group received sham tACS and at session 2 they received active 10Hz tACS
|
Active 10 Hz Then Sham tACS
At session 1 this group received active 10Hz tACS and at session 2 they received sham tACS
|
|---|---|---|
|
Washout (1-3 Weeks)
Lost to Follow-up
|
1
|
0
|
Baseline Characteristics
Transcranial Alternating Current Stimulation in Back Pain- Pilot Sudy
Baseline characteristics by cohort
| Measure |
Sham Then Active 10 Hz tACS
n=11 Participants
At session 1 this group received sham tACS and at session 2 they received active 10Hz tACS
|
Active 10 Hz Then Sham tACS
n=10 Participants
At session 1 this group received active 10Hz tACS and at session 2 they received sham 10Hz tACS
|
Total
n=21 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
42.6 years
STANDARD_DEVIATION 13.8 • n=5 Participants
|
43.4 years
STANDARD_DEVIATION 13.6 • n=7 Participants
|
43 years
STANDARD_DEVIATION 13.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
11 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
11 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
11 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
BMI
|
25.98 kg/m^2
STANDARD_DEVIATION 4.1 • n=5 Participants
|
25.92 kg/m^2
STANDARD_DEVIATION 5.1 • n=7 Participants
|
25.94 kg/m^2
STANDARD_DEVIATION 4.5 • n=5 Participants
|
|
Duration of Pain
|
4.8 years
STANDARD_DEVIATION 3.0 • n=5 Participants
|
9.3 years
STANDARD_DEVIATION 7.4 • n=7 Participants
|
7.1 years
STANDARD_DEVIATION 6.0 • n=5 Participants
|
PRIMARY outcome
Timeframe: before and after 40-minute stimulation at each sessionChanges in parasympathetic tone, increase in high frequency band input via spectral analysis on EKG recordings between active and sham stimulation
Outcome measures
| Measure |
Sham tACS
n=20 Participants
Sham Stimulation mimics the physical effects of stimulation, with up to one minute of stimulation during the session. Sham stimulation is delivered using the XCSITE100 Stimulator Sham.
XCSITE100 Stimulator Sham: The participant will receive up to one minute of tACS stimulation until the stimulation fades. Sham stimulation mimics the skin sensations a participant would experience during a tACS session
|
Active10 Hz tACS
n=20 Participants
Participants will receive 2mA of alternating current stimulation at a frequency of 10Hz for 40 minutes. tACS stimulation is delivered using the XCSITE100 Stimulator tACS.
XCSITE100 Stimulator tACS: Transcranial alternating current stimulation (tACS) is a method of noninvasive brain stimulation in which weak electrical current are applied to the scalp in a sine wave pattern to induce cortical oscillations at the frequency at which they are applied
|
|---|---|---|
|
Change in Heart Rate Variability Before and After 40-minute Stimulation
|
0.206 ms^2
Standard Deviation 0.76
|
-0.01 ms^2
Standard Deviation 0.56
|
PRIMARY outcome
Timeframe: 5 minute recordings before and after each 40-minute stimulation at each session.Changes in the EEG power in the alpha (8-12 Hz) band before and after 40-minute stimulation
Outcome measures
| Measure |
Sham tACS
n=20 Participants
Sham Stimulation mimics the physical effects of stimulation, with up to one minute of stimulation during the session. Sham stimulation is delivered using the XCSITE100 Stimulator Sham.
XCSITE100 Stimulator Sham: The participant will receive up to one minute of tACS stimulation until the stimulation fades. Sham stimulation mimics the skin sensations a participant would experience during a tACS session
|
Active10 Hz tACS
n=20 Participants
Participants will receive 2mA of alternating current stimulation at a frequency of 10Hz for 40 minutes. tACS stimulation is delivered using the XCSITE100 Stimulator tACS.
XCSITE100 Stimulator tACS: Transcranial alternating current stimulation (tACS) is a method of noninvasive brain stimulation in which weak electrical current are applied to the scalp in a sine wave pattern to induce cortical oscillations at the frequency at which they are applied
|
|---|---|---|
|
Change in Electroencephalogram Power in Alpha Band Before and After 40-minute Stimulation
|
0.03 square microvolts
Standard Deviation 0.16
|
0.4 square microvolts
Standard Deviation 0.15
|
SECONDARY outcome
Timeframe: before and after 40 minute stimulation sessionSelf reported pain rating using a Visual Analog Scale (VAS) ranging from 0-10 done before and after stimulation with '0' being no pain and '10' as bad as it could be. Lower values represent a better outcome. (Pain difference was normalized using modulation index to account for ordinal scale)
Outcome measures
| Measure |
Sham tACS
n=20 Participants
Sham Stimulation mimics the physical effects of stimulation, with up to one minute of stimulation during the session. Sham stimulation is delivered using the XCSITE100 Stimulator Sham.
XCSITE100 Stimulator Sham: The participant will receive up to one minute of tACS stimulation until the stimulation fades. Sham stimulation mimics the skin sensations a participant would experience during a tACS session
|
Active10 Hz tACS
n=20 Participants
Participants will receive 2mA of alternating current stimulation at a frequency of 10Hz for 40 minutes. tACS stimulation is delivered using the XCSITE100 Stimulator tACS.
XCSITE100 Stimulator tACS: Transcranial alternating current stimulation (tACS) is a method of noninvasive brain stimulation in which weak electrical current are applied to the scalp in a sine wave pattern to induce cortical oscillations at the frequency at which they are applied
|
|---|---|---|
|
Change in Pain Rating on the Visual Analog Scale Before and After 40-minute Stimulation
|
-0.178 units on a scale
Standard Deviation 0.97
|
0.18 units on a scale
Standard Deviation 0.31
|
Adverse Events
Sham tACS
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Active 10 Hz tACS
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