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BreEStim and tDCS for Neuropathic Pain Management - Healthy Subjects

Primary Purpose

Pain Management

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
BreEStim
tDCS active
tDCS sham
Sponsored by
The University of Texas Health Science Center, Houston
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain Management

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • TIRR

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Sham tDCS and BreEStim

active tDCS (M1) and BreEStim

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Full Information

First Posted
October 1, 2017
Last Updated
April 2, 2021
Sponsor
The University of Texas Health Science Center, Houston
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1. Study Identification

Unique Protocol Identification Number
NCT03302780
Brief Title
BreEStim and tDCS for Neuropathic Pain Management - Healthy Subjects
Official Title
Combined Peripheral (BreEStim) and Central Electrical Stimulation (tDCS) for Neuropathic Pain Management
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
April 6, 2016 (Actual)
Primary Completion Date
May 26, 2016 (Actual)
Study Completion Date
May 26, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Texas Health Science Center, Houston

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain Management

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
6 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Sham tDCS and BreEStim
Arm Type
Experimental
Arm Description
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.
Arm Title
active tDCS (M1) and BreEStim
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
BreEStim
Intervention Description
BreEStim will applied for 10 to 20 minutes.
Intervention Type
Device
Intervention Name(s)
tDCS active
Intervention Description
tDCS will be applied for 20 minutes.
Intervention Type
Device
Intervention Name(s)
tDCS sham
Primary Outcome Measure Information:
Title
Electrical Pain Threshold (EPT)
Description
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
Title
Electrical Sensation Threshold (EST)
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sheng Li, MD, PhD
Organizational Affiliation
The University of Texas Health Science Center, Houston
Official's Role
Principal Investigator
Facility Information:
Facility Name
TIRR
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

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BreEStim and tDCS for Neuropathic Pain Management - Healthy Subjects

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