Pain Management
Conditions
Brief summary
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 healthy volunteers. Note that this study will also enroll spinal cord injury patients, brain injury patients, and amputation patients and that this study as applied to these other populations will be covered in separate ClinicalTrials.gov records.
Interventions
DEVICEBreEStim
BreEStim will applied for 10 to 20 minutes.
DEVICEtDCS active
tDCS will be applied for 20 minutes.
DEVICEtDCS sham
Sponsors
The University of Texas Health Science Center, Houston
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
* between 18 and 75 years * male and female subjects * healthy subjects (i.e., no recent injuries or pain)
Exclusion criteria
* recent injuries or pain * have a pacemaker, or other metal and/or implanted devices * have amputation in their arm(s) * have spinal cord injury (SCI) involving impairment of arms * have cognitive impairment from brain injury or are not able to follow commands, or to give consent * have asthma or other pulmonary disease * are not medically stable * have preexisting psychiatric disorders * alcohol or drug abuse * have a history of seizures/Epilepsy, or taking benzodiazepines, anticonvulsants, and antidepressants. * Mini-mental state examination (MMSE), a brief 30-point questionnaire test that is commonly used in the literature, will be used to screen for cognitive impairment. A brain injury patient with a score of 24 or lower on MMSE will be excluded.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Electrical Pain Threshold (EPT) | baseline, 10 minutes after tDCS, 10 minutes after BreEstim | Electrical Pain Threshold (EPT) is a type of quantitative sensory test that assesses the lowest electrical current that first evokes a sensation of pricking pain. |
| Electrical Sensation Threshold (EST) | baseline, 10 minutes after tDCS, 10 minutes after BreEstim | Electrical Detection Threshold (EDT) is a type of Quantitative sensory test that assesses the lowest electrical current that first evokes an electrical sensation. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| All 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. | 6 |
| Total | 6 |
Baseline characteristics
| Characteristic | All Participants |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 6 Participants |
| Age, Continuous | 34 years |
| Region of Enrollment United States | 6 participants |
| Sex: Female, Male Female | 1 Participants |
| Sex: Female, Male Male | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 6 | 0 / 6 |
| other Total, other adverse events | 0 / 6 | 0 / 6 |
| serious Total, serious adverse events | 0 / 6 | 0 / 6 |
Outcome results
Primary
Electrical Pain Threshold (EPT)
Electrical Pain Threshold (EPT) is a type of quantitative sensory test that assesses the lowest electrical current that first evokes a sensation of pricking pain.
Time frame: baseline, 10 minutes after tDCS, 10 minutes after BreEstim
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Sham tDCS and BreEStim | Electrical Pain Threshold (EPT) | Baseline | 23.83 mA | Standard Deviation 6.79 |
| Sham tDCS and BreEStim | Electrical Pain Threshold (EPT) | After tDCS | 24.08 mA | Standard Deviation 7.68 |
| Sham tDCS and BreEStim | Electrical Pain Threshold (EPT) | After BreEstim | 26.70 mA | Standard Deviation 7.68 |
| Active tDCS (M1) and BreEStim | Electrical Pain Threshold (EPT) | Baseline | 22.41 mA | Standard Deviation 4.67 |
| Active tDCS (M1) and BreEStim | Electrical Pain Threshold (EPT) | After tDCS | 20.41 mA | Standard Deviation 3.01 |
| Active tDCS (M1) and BreEStim | Electrical Pain Threshold (EPT) | After BreEstim | 23.77 mA | Standard Deviation 6.78 |
Primary
Electrical Sensation Threshold (EST)
Electrical Detection Threshold (EDT) is a type of Quantitative sensory test that assesses the lowest electrical current that first evokes an electrical sensation.
Time frame: baseline, 10 minutes after tDCS, 10 minutes after BreEstim
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Sham tDCS and BreEStim | Electrical Sensation Threshold (EST) | Baseline | 4.05 mA | Standard Deviation 1.07 |
| Sham tDCS and BreEStim | Electrical Sensation Threshold (EST) | After tDCS | 3.99 mA | Standard Deviation 0.86 |
| Sham tDCS and BreEStim | Electrical Sensation Threshold (EST) | After BreEstim | 3.95 mA | Standard Deviation 0.74 |
| Active tDCS (M1) and BreEStim | Electrical Sensation Threshold (EST) | After BreEstim | 3.59 mA | Standard Deviation 0.64 |
| Active tDCS (M1) and BreEStim | Electrical Sensation Threshold (EST) | Baseline | 3.54 mA | Standard Deviation 0.92 |
| Active tDCS (M1) and BreEStim | Electrical Sensation Threshold (EST) | After tDCS | 3.39 mA | Standard Deviation 0.53 |