An interventional study of BreEStim and tDCS in Pain Management, sponsored by The University of Texas Health Science Center, Houston. Completed at 1 site in United States. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2019-01-24.
Sponsored by The University of Texas Health Science Center, Houston · Not applicable, Interventional, and Treatment
This study looks at the effect of combined breathing-controlled electrical stimulation (BreEStim) and transcranial direct current stimulation (tDCS) on neuropathic pain after spinal cord injury, amputation, or brain injury. The hypothesis is that a single session of combined BreEStim and tDCS will produce an additive analgesic effect. This record covers the study in a population of spinal cord injury patients. Note that this study will also enroll healthy volunteers, brain injury patients, and amputation patients and that this study as applied to these other populations will be covered in separate ClinicalTrials.gov records.
Exclusion Criteria:
BreEStim is voluntary breathing controlled electrical stimulation.
Device: BreEStim · Device: tDCS · Device: tDCS sham
BreEStim is voluntary breathing controlled electrical stimulation. tDCS is transcranial direct current stimulation.
Device: BreEStim · Device: tDCS · Device: tDCS sham
BreEStim will applied for 10 to 20 minutes.
tDCS will be applied for 20 minutes.
Pain as Assessed by Visual Analogue Scale (VAS)
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.
Time frame: baseline, 10 minutes after tDCS, 10 minutes after BreEstim
Electrical Pain Threshold
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.
Time frame: baseline, 10 minutes after tDCS, 10 minutes after BreEstim
Electrical Sensation Threshold
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.
Time frame: baseline, 10 minutes after tDCS, 10 minutes after BreEstim
| Milestone | Sham tDCS and Then BreEStim; Then M1 tDCS and Then BreEstim | M1 tDCS and Then BreEStim; Then Sham tDCS and Then BreEstim |
|---|---|---|
| Started | 6 | 6 |
| Completed | 6 | 4 |
| Not completed | 0 | 2 |
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.
| units on a scale | Sham tDCS and Then BreEStim | Active tDCS (M1) and Then BreEStim |
|---|---|---|
| baseline | 6.0 ± 2.03 | 5.9 ± 1.65 |
| After tDCS | 5.4 ± 2.26 | 5.3 ± 1.66 |
| After BreEstim | 3.5 ± 1.91 | 3.1 ± 2.08 |
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.
| mA | Sham tDCS and Then BreEStim | Active tDCS (M1) and Then BreEStim |
|---|---|---|
| Baseline | 30.4 ± 25.53 | 35.0 ± 26.04 |
| After tDCS | 31.1 ± 27.05 | 33.9 ± 26.37 |
| After BreEstim | 34.5 ± 24.14 | 35.2 ± 21.58 |
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.
| mA | Sham tDCS and Then BreEStim | Active tDCS (M1) and Then BreEStim |
|---|---|---|
| Baseline | 7.3 ± 2.41 | 8.4 ± 2.59 |
| After tDCS | 7.4 ± 2.84 | 8.1 ± 2.51 |
| After BreEstim | 7.3 ± 2.66 | 8.3 ± 2.47 |
Collected over 16 hours after treatment. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Sham tDCS and Then BreEStim | 0/10 (0%) | 0/10 (0%) | 0/10 (0%) |
| Active tDCS (M1) and Then BreEStim | 0/12 (0%) | 0/12 (0%) | 0/12 (0%) |
2 subjects only finished Combined active tDCS (M1) and BreEStim section, but didn't attend the Sham tDCS and BreEStim section.
| Age, Categorical(Participants) | All Participants |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 12 |
| >=65 years | 0 |
| Sex: Female, Male(Participants) | All Participants |
|---|---|
| Female | 5 |
| Male | 7 |
| Race/Ethnicity, Customized(Participants) | All Participants |
|---|---|
| White | 7 |
| Black | 2 |
| Hispanic | 3 |
| Region of Enrollment(Participants) | All Participants |
|---|---|
| United States | 12 |
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The University of Texas Health Science Center, Houston