Pain ManagementNCT03302793
Combined Peripheral (BreEStim) and Central Electrical Stimulation (tDCS) for Neuropathic Pain Management - Spinal Cord Injury
A study testing BreEStim and tDCS in people with Pain Management, run by The University of Texas Health Science Center, Houston at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Pain Management
- What is being tested?
- BreEStim and tDCS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2015to Dec 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- between 18 and 75 years
- male and female subjects
- has neuropathic pain after traumatic spinal cord injury
- has chronic pain, >3 months
- is stable on oral pain medications at least two weeks. (patients are allowed to continue their pain medications, i.e., no change in pain medications.)
Who cannot join
- currently adjusting oral pain medications for their neuropathic pain
- have pain, but not neuropathic (e.g., from inflammation at the incision wound of the residual limb or neuroma)
- 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
Show all 12Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Combined Peripheral (BreEStim) and Central Electrical Stimulation (tDCS) for Neuropathic Pain Management
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.
- Conditions
- Pain Management
- Being tested
- BreEStim, tDCS, tDCS sham
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BreEStimDevice
BreEStim will applied for 10 to 20 minutes.
tDCSDevice
tDCS will be applied for 20 minutes.
tDCS shamDevice
| Study group | Role | What they receive |
|---|---|---|
| BreEStim and tDCS sham, then combined BreEStim and tDCS | Experimental | BreEStim is voluntary breathing controlled electrical stimulation. Receives: Device: BreEStim; Device: tDCS; Device: tDCS sham |
| Combined BreEStim and tDCS, then BreEStim and tDCS sham | Experimental | BreEStim is voluntary breathing controlled electrical stimulation. tDCS is transcranial direct current stimulation. Receives: Device: BreEStim; Device: tDCS; Device: tDCS sham |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: baseline, 10 minutes after tDCS, 10 minutes after BreEstim
Secondary outcomes (2)
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.
Measured: 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.
Measured: baseline, 10 minutes after tDCS, 10 minutes after BreEstim
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2017
- Study startApr 2015
- Primary completionDec 2017
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pain ManagementStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center, HoustonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sheng Li, The University of Texas Health Science Center, Houston
- Investigators
- Sheng Li, MD, PhD, Principal investigator, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03302793
- Sponsor's protocol ID
- HSC-MS-14-0564 SCI
- Status last verified
- Jan 2019
- First submitted
- 1 Oct 2017
- Last updated
- 24 Jan 2019
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
Li S, Stampas A, Frontera J, Davis M, Li S. Combined transcranial direct current stimulation and breathing-controlled electrical stimulation for management of neuropathic pain after spinal cord injury. J Rehabil Med. 2018 Sep 28;50(9):814-820. doi: 10.2340/16501977-2379.
PubMed 30132010
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combined Peripheral (BreEStim) and Central Electrical Stimulation (tDCS) for Neuropathic Pain Management
- ClinicalTrials.gov ID
- NCT03302793
- Acronym / sponsor ID
- HSC-MS-14-0564 SCI
- Conditions
- Pain Management
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Study start
- Apr 2015
- Primary completion
- Dec 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 5 Oct 2017 (actual)
- Results
- Posted 24 Jan 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BreEStim and tDCS sham, then combined BreEStim and tDCS | Experimental | Device: BreEStim, Device: tDCS, Device: tDCS shamBreEStim is voluntary breathing controlled electrical stimulation. |
| Combined BreEStim and tDCS, then BreEStim and tDCS sham | Experimental | Device: BreEStim, Device: tDCS, Device: tDCS shamBreEStim is voluntary breathing controlled electrical stimulation. tDCS is transcranial direct current stimulation. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- between 18 and 75 years
- male and female subjects
- has neuropathic pain after traumatic spinal cord injury
- has chronic pain, >3 months
- is stable on oral pain medications at least two weeks. (patients are allowed to continue their pain medications, i.e., no change in pain medications.)
Key exclusion criteria (12 listed)
- currently adjusting oral pain medications for their neuropathic pain
- have pain, but not neuropathic (e.g., from inflammation at the incision wound of the residual limb or neuroma)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BreEStimBreEStim will applied for 10 to 20 minutes. | Device | BreEStim and tDCS sham, then combined BreEStim and tDCS, Combined BreEStim and tDCS, then BreEStim and tDCS sham |
| tDCStDCS will be applied for 20 minutes. | Device | BreEStim and tDCS sham, then combined BreEStim and tDCS, Combined BreEStim and tDCS, then BreEStim and tDCS sham |
| tDCS sham | Device | BreEStim and tDCS sham, then combined BreEStim and tDCS, Combined BreEStim and tDCS, then BreEStim and tDCS sham |
Primary outcome
Pain as Assessed by Visual Analogue Scale (VAS)
Time frame: baseline, 10 minutes after tDCS, 10 minutes after BreEstim
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.
2 secondary outcomes
Electrical Pain Threshold
Time frame: baseline, 10 minutes after tDCS, 10 minutes after BreEstim
Electrical Sensation Threshold
Time frame: baseline, 10 minutes after tDCS, 10 minutes after BreEstim
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 30132010Li S, Stampas A, Frontera J, Davis M, Li S. Combined transcranial direct current stimulation and breathing-controlled electrical stimulation for management of neuropathic pain after spinal cord injury. J Rehabil Med. 2018 Sep 28;50(9):814-820. doi: 10.2340/16501977-2379.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sheng Li, MD, PhD principal investigator
The University of Texas Health Science Center, Houston
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BreEStim and tDCS in people with Pain Management, run by The University of Texas Health Science Center, Houston at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Jan 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain as Assessed by Visual Analogue Scale (VAS) (time frame: baseline, 10 minutes after tDCS, 10 minutes after BreEstim). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03302793, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jan 2019.