BreEStim and tDCS for Neuropathic Pain Management - Healthy Subjects

Sponsor
The University of Texas Health Science Center, Houston (Other)
Overall Status
Completed
CT.gov ID
NCT03302780
Collaborator
(none)
6
Enrollment
1
Location
2
Arms
1.6
Actual Duration (Months)
3.7
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or DiseaseIntervention/TreatmentPhase
  • Device: BreEStim
  • Device: tDCS active
  • Device: tDCS sham
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
6 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Single (Participant)
Primary Purpose:
Treatment
Official Title:
Combined Peripheral (BreEStim) and Central Electrical Stimulation (tDCS) for Neuropathic Pain Management
Actual Study Start Date :
Apr 6, 2016
Actual Primary Completion Date :
May 26, 2016
Actual Study Completion Date :
May 26, 2016

Arms and Interventions

ArmIntervention/Treatment
Experimental: Sham tDCS and BreEStim

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.

Device: BreEStim
BreEStim will applied for 10 to 20 minutes.

Device: tDCS sham

Experimental: active tDCS (M1) and BreEStim

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.

Device: BreEStim
BreEStim will applied for 10 to 20 minutes.

Device: tDCS active
tDCS will be applied for 20 minutes.

Outcome Measures

Primary Outcome Measures

  1. 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.

  2. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
All
Accepts 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.

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1TIRRHoustonTexasUnited States77030

Sponsors and Collaborators

  • The University of Texas Health Science Center, Houston

Investigators

  • Principal Investigator: Sheng Li, MD, PhD, The University of Texas Health Science Center, Houston

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Sheng Li, PhysicianProfessor, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier:
NCT03302780
Other Study ID Numbers:
  • HSC-MS-14-0564 Healthy
First Posted:
Oct 5, 2017
Last Update Posted:
Apr 27, 2021
Last Verified:
Apr 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
Yes
Additional relevant MeSH terms:

Study Results

Participant Flow

Recruitment Details
Pre-assignment Detail
Arm/Group TitleSham tDCS and BreEStim; Then M1 tDCS and BreEstimM1 tDCS and BreEStim; Then Sham tDCS and BreEstim
Arm/Group DescriptionThis 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.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.
Period Title: Overall Study
STARTED33
COMPLETED33
NOT COMPLETED00

Baseline Characteristics

Arm/Group TitleAll Participants
Arm/Group DescriptionThis 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.
Overall Participants6
Age (Count of Participants)
<=18 years
0
0%
Between 18 and 65 years
6
100%
>=65 years
0
0%
Age (years) [Mean (Full Range) ]
Mean (Full Range) [years]
34
Sex: Female, Male (Count of Participants)
Female
1
16.7%
Male
5
83.3%
Region of Enrollment (participants) [Number]
United States
6
100%

Outcome Measures

1. Primary Outcome
TitleElectrical Pain Threshold (EPT)
DescriptionElectrical 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 Framebaseline, 10 minutes after tDCS, 10 minutes after BreEstim

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group TitleSham tDCS and BreEStimActive tDCS (M1) and BreEStim
Arm/Group DescriptionThis 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.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.
Measure Participants66
Baseline
23.83
(6.79)
22.41
(4.67)
After tDCS
24.08
(7.68)
20.41
(3.01)
After BreEstim
26.70
(7.68)
23.77
(6.78)
2. Primary Outcome
TitleElectrical Sensation Threshold (EST)
DescriptionElectrical Detection Threshold (EDT) is a type of Quantitative sensory test that assesses the lowest electrical current that first evokes an electrical sensation.
Time Framebaseline, 10 minutes after tDCS, 10 minutes after BreEstim

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group TitleSham tDCS and BreEStimActive tDCS (M1) and BreEStim
Arm/Group DescriptionThis 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.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.
Measure Participants66
Baseline
4.05
(1.07)
3.54
(0.92)
After tDCS
3.99
(0.86)
3.39
(0.53)
After BreEstim
3.95
(0.74)
3.59
(0.64)

Adverse Events

Time Frame1 hour after treatment
Adverse Event Reporting Description
Arm/Group TitleSham tDCS and BreEStimActive tDCS (M1) and BreEStim
Arm/Group DescriptionThis 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.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.
All Cause Mortality
Sham tDCS and BreEStimActive tDCS (M1) and BreEStim
Affected / at Risk (%)# EventsAffected / at Risk (%)# Events
Total0/6 (0%) 0/6 (0%)
Serious Adverse Events
Sham tDCS and BreEStimActive tDCS (M1) and BreEStim
Affected / at Risk (%)# EventsAffected / at Risk (%)# Events
Total0/6 (0%) 0/6 (0%)
Other (Not Including Serious) Adverse Events
Sham tDCS and BreEStimActive tDCS (M1) and BreEStim
Affected / at Risk (%)# EventsAffected / at Risk (%)# Events
Total0/6 (0%) 0/6 (0%)

Limitations/Caveats

Study stopped early, and small numbers of subjects analyzed.

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact

Name/TitleSheng Li, MD, PhD
OrganizationUniversity of Texas McGovern Medical School - Houston
Phone7137977125 ext 713
Emailsheng.li@uth.tmc.edu
Responsible Party:
Sheng Li, PhysicianProfessor, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier:
NCT03302780
Other Study ID Numbers:
  • HSC-MS-14-0564 Healthy
First Posted:
Oct 5, 2017
Last Update Posted:
Apr 27, 2021
Last Verified:
Apr 1, 2021