Trial Outcomes & Findings for Combined Peripheral (BreEStim) and Central Electrical Stimulation (tDCS) for Neuropathic Pain Management - Spinal Cord Injury (NCT NCT03302793)
NCT ID: NCT03302793
Last Updated: 2019-01-24
Results Overview
A Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured. It is often used in epidemiologic and clinical research to measure the intensity or frequency of various symptoms. To allow a continuous assessment of pain, VAS uses a 10 cm line labelled at '0' with 'no pain' and '10' with 'worst pain'. The line is marked at a point corresponding to the assessment of the pain.
COMPLETED
NA
12 participants
baseline, 10 minutes after tDCS, 10 minutes after BreEstim
2019-01-24
Participant Flow
Participant milestones
| Measure |
Sham tDCS and Then BreEStim; Then M1 tDCS and Then BreEstim
This study has a single-blinded, single-center, sham-controlled, crossover design. It included 2 separate visits, each with either a 20-min sham tDCS or M1 tDCS to the current dominant primary motor cortex(M1), both followed by a 20-min BreEStim to the median nerve(160 times) transcutaneously on the current dominant side.
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M1 tDCS and Then BreEStim; Then Sham tDCS and Then BreEstim
This study has a single-blinded, single-center, sham-controlled, crossover design. It included 2 separate visits, each with either a 20-min sham tDCS or M1 tDCS to the current dominant primary motor cortex(M1), both followed by a 20-min BreEStim to the median nerve(160 times) transcutaneously on the current dominant side.
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|---|---|---|
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Overall Study
STARTED
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6
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6
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Overall Study
COMPLETED
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6
|
4
|
|
Overall Study
NOT COMPLETED
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0
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Combined Peripheral (BreEStim) and Central Electrical Stimulation (tDCS) for Neuropathic Pain Management - Spinal Cord Injury
Baseline characteristics by cohort
| Measure |
All Participants
n=12 Participants
This study has a single-blinded, single-center, sham-controlled, crossover design. It included 2 separate visits, each with either a 20-min sham tDCS or M1 tDCS to the current dominant primary motor cortex(M1), both followed by a 20-min BreEStim to the median nerve(160 times) transcutaneously on the current dominant side.
|
|---|---|
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Age, Categorical
Between 18 and 65 years
|
12 Participants
n=5 Participants
|
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Age, Categorical
>=65 years
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0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
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5 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
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7 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
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2 Participants
n=5 Participants
|
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Race/Ethnicity, Customized
Hispanic
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3 Participants
n=5 Participants
|
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Region of Enrollment
United States
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12 Participants
n=5 Participants
|
|
Age, Categorical
<=18 years
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0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: baseline, 10 minutes after tDCS, 10 minutes after BreEstimPopulation: In the Sham tDCS and then BreEStim arm, only 10 participants were analyzed because 2 patients did not return for the second visit.
A Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured. It is often used in epidemiologic and clinical research to measure the intensity or frequency of various symptoms. To allow a continuous assessment of pain, VAS uses a 10 cm line labelled at '0' with 'no pain' and '10' with 'worst pain'. The line is marked at a point corresponding to the assessment of the pain.
Outcome measures
| Measure |
Sham tDCS and Then BreEStim
n=10 Participants
This study has a single-blinded, single-center, sham-controlled, crossover design. It included a 20-min sham tDCS to the current dominant primary motor cortex(M1), followed by a 20-min BreEStim to the median nerve(160 times) transcutaneously on the current dominant side.
|
Active tDCS (M1) and Then BreEStim
n=12 Participants
This study has a single-blinded, single-center, sham-controlled, crossover design. It included a 20-min active tDCS to the current dominant primary motor cortex(M1), followed by a 20-min BreEStim to the median nerve(160 times) transcutaneously on the current dominant side.
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|---|---|---|
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Pain as Assessed by Visual Analogue Scale (VAS)
baseline
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6.0 units on a scale
Standard Deviation 2.03
|
5.9 units on a scale
Standard Deviation 1.65
|
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Pain as Assessed by Visual Analogue Scale (VAS)
After tDCS
|
5.4 units on a scale
Standard Deviation 2.26
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5.3 units on a scale
Standard Deviation 1.66
|
|
Pain as Assessed by Visual Analogue Scale (VAS)
After BreEstim
|
3.5 units on a scale
Standard Deviation 1.91
|
3.1 units on a scale
Standard Deviation 2.08
|
SECONDARY outcome
Timeframe: baseline, 10 minutes after tDCS, 10 minutes after BreEstimPopulation: In the Sham tDCS and then BreEStim arm, only 10 participants were analyzed because 2 patients did not return for the second visit.
Trimmed surface electrodes (1 inch by 1 inch) were used to examine electrical pain thresholds upon application of electrical stimulation (electrical stimulator 7SA, Digitimer). To measure electrical pain threshold, a pair of electrodes was placed next to each other centered on the thenar eminence (which is a group of muscles on the palm of the human hand at the base of the thumb); the intensity of electrical stimulation was started from the sensation threshold level (determined in outcome measure 3) and increased in steps of 1 mA; and subjects were instructed to close their eyes and to say ''yes'' when they first felt electrical stimulation painful. The electrical pain threshold is the mA level at which a participant first felt electrical stimulation painful. To improve consistency among subjects, they were advised that the pain threshold level was equivalent to 1 on the 0-10 VAS scale. Three repetitions were made and the average was used as the electrical pain threshold.
Outcome measures
| Measure |
Sham tDCS and Then BreEStim
n=10 Participants
This study has a single-blinded, single-center, sham-controlled, crossover design. It included a 20-min sham tDCS to the current dominant primary motor cortex(M1), followed by a 20-min BreEStim to the median nerve(160 times) transcutaneously on the current dominant side.
|
Active tDCS (M1) and Then BreEStim
n=12 Participants
This study has a single-blinded, single-center, sham-controlled, crossover design. It included a 20-min active tDCS to the current dominant primary motor cortex(M1), followed by a 20-min BreEStim to the median nerve(160 times) transcutaneously on the current dominant side.
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|---|---|---|
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Electrical Pain Threshold
Baseline
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30.4 mA
Standard Deviation 25.53
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35.0 mA
Standard Deviation 26.04
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Electrical Pain Threshold
After tDCS
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31.1 mA
Standard Deviation 27.05
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33.9 mA
Standard Deviation 26.37
|
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Electrical Pain Threshold
After BreEstim
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34.5 mA
Standard Deviation 24.14
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35.2 mA
Standard Deviation 21.58
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SECONDARY outcome
Timeframe: baseline, 10 minutes after tDCS, 10 minutes after BreEstimPopulation: In the Sham tDCS and then BreEStim arm, only 10 participants were analyzed because 2 patients did not return for the second visit.
Trimmed surface electrodes (1 inch by 1 inch) were used to examine electrical sensation threshold upon application of electrical stimulation (electrical stimulator 7SA, Digitimer). To measure electrical sensation threshold, a pair of electrodes was placed next to each other centered on the thenar eminence (which is a group of muscles on the palm of the human hand at the base of the thumb); the intensity of electrical stimulation was started from zero and gradually increased in steps of 0.1 mA; and subjects were instructed to close their eyes and to say ''yes'' when they explicitly felt electrical stimulation. The electrical sensation threshold is the mA level at which a participant explicitly felt electrical stimulation. Three repetitions were made and the average was used as the electrical sensation threshold.
Outcome measures
| Measure |
Sham tDCS and Then BreEStim
n=10 Participants
This study has a single-blinded, single-center, sham-controlled, crossover design. It included a 20-min sham tDCS to the current dominant primary motor cortex(M1), followed by a 20-min BreEStim to the median nerve(160 times) transcutaneously on the current dominant side.
|
Active tDCS (M1) and Then BreEStim
n=12 Participants
This study has a single-blinded, single-center, sham-controlled, crossover design. It included a 20-min active tDCS to the current dominant primary motor cortex(M1), followed by a 20-min BreEStim to the median nerve(160 times) transcutaneously on the current dominant side.
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|---|---|---|
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Electrical Sensation Threshold
Baseline
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7.3 mA
Standard Deviation 2.41
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8.4 mA
Standard Deviation 2.59
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Electrical Sensation Threshold
After tDCS
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7.4 mA
Standard Deviation 2.84
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8.1 mA
Standard Deviation 2.51
|
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Electrical Sensation Threshold
After BreEstim
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7.3 mA
Standard Deviation 2.66
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8.3 mA
Standard Deviation 2.47
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Adverse Events
Sham tDCS and Then BreEStim
Active tDCS (M1) and Then BreEStim
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