NCT03302780

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2016

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 6, 2016

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 26, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 26, 2016

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

October 1, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 5, 2017

Completed
3.2 years until next milestone

Results Posted

Study results publicly available

December 3, 2020

Completed
Last Updated

April 27, 2021

Status Verified

April 1, 2021

Enrollment Period

2 months

First QC Date

October 1, 2017

Results QC Date

November 6, 2020

Last Update Submit

April 2, 2021

Conditions

Pain Management

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    baseline, 10 minutes after tDCS, 10 minutes after BreEstim

Study Arms (2)

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.

Device: BreEStimDevice: 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.

Device: BreEStimDevice: tDCS active

Interventions

BreEStimDEVICE

BreEStim will applied for 10 to 20 minutes.

Sham tDCS and BreEStimactive tDCS (M1) and BreEStim
tDCS activeDEVICE

tDCS will be applied for 20 minutes.

active tDCS (M1) and BreEStim
tDCS shamDEVICE
Sham tDCS and BreEStim

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • between 18 and 75 years
  • male and female subjects
  • healthy subjects (i.e., no recent injuries or pain)

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

TIRR

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Agnosia

Condition Hierarchy (Ancestors)

Perceptual DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Limitations and Caveats

Study stopped early, and small numbers of subjects analyzed.

Results Point of Contact

Title
Sheng Li, MD, PhD
Organization
University of Texas McGovern Medical School - Houston
sheng.li@uth.tmc.edu
7137977125

Study Officials

  • Sheng Li, MD, PhD

    The University of Texas Health Science Center, Houston

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhysicianProfessor

Study Record Dates

First Submitted

October 1, 2017

First Posted

October 5, 2017

Study Start

April 6, 2016

Primary Completion

May 26, 2016

Study Completion

May 26, 2016

Last Updated

April 27, 2021

Results First Posted

December 3, 2020

Record last verified: 2021-04

Locations

US(1)