BreEStim and tDCS for Neuropathic Pain Management - Healthy Subjects

Not Applicable

Completed

• Conditions: Pain Management
• Interventions: Device: BreEStim; Device: tDCS active; Device: tDCS sham

• Registration Number: NCT03302780
• Lead Sponsor: The University of Texas Health Science Center, Houston

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-04-06
• Primary Completion: 2016-05-26
• Study Completion: 2016-05-26
• Study First Submitted: 2017-10-01
• Study First Submitted QC: 2017-10-01
• Study First Posted: 2017-10-05
• Disposition First Submitted: 2020-08-17
• Disposition First Submitted QC: 2020-08-17
• Disposition First Posted: 2020-08-21
• Results First Submitted: 2020-11-06
• Results First Submitted QC: 2020-11-06
• Results First Posted: 2020-12-03
• Status Verified: 2021-04
• Last Update Submitted: 2021-04-02
• Last Update Posted: 2021-04-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 6

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Sham tDCS and BreEStim	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.
active tDCS (M1) and BreEStim	tDCS active	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.
Sham tDCS and BreEStim	tDCS sham	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.
active tDCS (M1) and BreEStim	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.

Primary Outcome Measures

Name	Time	Method
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.
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.

Trial Locations

Locations (1)

TIRR; 🇺🇸 Houston, Texas, United States