BreEStim and tDCS for Neuropathic Pain Management - Healthy Subjects

NCT ID: NCT03302780

Last Updated: 2021-04-27

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

6 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-04-06

Study Completion Date

2016-05-26

Brief Summary

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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.

Detailed Description

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Conditions

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Pain Management

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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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.

Group Type EXPERIMENTAL

BreEStim

Intervention Type DEVICE

BreEStim will applied for 10 to 20 minutes.

tDCS sham

Intervention Type DEVICE

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.

Group Type EXPERIMENTAL

BreEStim

Intervention Type DEVICE

BreEStim will applied for 10 to 20 minutes.

tDCS active

Intervention Type DEVICE

tDCS will be applied for 20 minutes.

Interventions

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BreEStim

BreEStim will applied for 10 to 20 minutes.

Intervention Type DEVICE

tDCS active

tDCS will be applied for 20 minutes.

Intervention Type DEVICE

tDCS sham

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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The University of Texas Health Science Center, Houston

OTHER

Sponsor Role lead

Responsible Party

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Sheng Li

PhysicianProfessor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sheng Li, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

The University of Texas Health Science Center, Houston

Locations

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TIRR

Houston, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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HSC-MS-14-0564 Healthy

Identifier Type: -

Identifier Source: org_study_id

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