Pain ManagementNCT03302780
BreEStim and tDCS for Neuropathic Pain Management - Healthy Subjects
A study testing BreEStim and tDCS active 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 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain Management
- What is being tested?
- BreEStim and tDCS active
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Apr 2016to 26 May 2016
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- between 18 and 75 years
- male and female subjects
- healthy subjects (i.e., no recent injuries or pain)
Who cannot join
- 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
Show all 11Show fewer
- 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 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.
- Conditions
- Pain Management
- Being tested
- BreEStim, tDCS active, 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.
tDCS activeDevice
tDCS will be applied for 20 minutes.
tDCS shamDevice
| Study group | Role | What they receive |
|---|---|---|
| Sham tDCS and BreEStim | Experimental | This arm includes 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. Receives: Device: BreEStim; Device: tDCS sham |
| active tDCS (M1) and BreEStim | Experimental | This arm includes 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. Receives: Device: BreEStim; Device: tDCS active |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: baseline, 10 minutes after tDCS, 10 minutes after BreEstim
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.
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 start6 Apr 2016
- Primary completion26 May 2016
- Study completion26 May 2016
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.
- 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
- 6 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
- NCT03302780
- Sponsor's protocol ID
- HSC-MS-14-0564 Healthy
- Status last verified
- Apr 2021
- First submitted
- 1 Oct 2017
- Last updated
- 27 Apr 2021
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2021. 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
- NCT03302780
- Acronym / sponsor ID
- HSC-MS-14-0564 Healthy
- Conditions
- Pain Management
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Study start
- 6 Apr 2016 (actual)
- Primary completion
- 26 May 2016 (actual)
- Study completion
- 26 May 2016 (actual)
- First posted
- 5 Oct 2017 (actual)
- Results
- Posted 3 Dec 2020
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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sham tDCS and BreEStim | Experimental | Device: BreEStim, Device: tDCS shamThis arm includes 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 BreEStim | Experimental | Device: BreEStim, Device: tDCS activeThis arm includes 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- between 18 and 75 years
- male and female subjects
- healthy subjects (i.e., no recent injuries or pain)
Key exclusion criteria (11 listed)
- 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
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 | Sham tDCS and BreEStim, active tDCS (M1) and BreEStim |
| tDCS activetDCS will be applied for 20 minutes. | Device | active tDCS (M1) and BreEStim |
| tDCS sham | Device | Sham tDCS and BreEStim |
Primary outcome
Electrical Pain Threshold (EPT)
Time frame: 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)
Time frame: 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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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 active 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 3 inclusion and 11 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 27 Apr 2021. 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 3 Dec 2020). 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?
Electrical Pain Threshold (EPT) (time frame: baseline, 10 minutes after tDCS, 10 minutes after BreEstim). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Apr 2021.