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Completed

NCT Number: NCT03302780

BreEStim and tDCS for Neuropathic Pain Management - Healthy Subjects

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.

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Key information

Conditions

Pain Management Agnosia Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Perceptual Disorders Signs and Symptoms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

TIRR

Houston, Texas, 77030, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

BreEStim

Device

BreEStim will applied for 10 to 20 minutes.

tDCS active

Device

tDCS will be applied for 20 minutes.

tDCS sham

Device

Primary outcomes

  1. Electrical Pain Threshold (EPT)

    Time frame: 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)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

The University of Texas Health Science Center, Houston

Other

Registry information

Official study title

Combined Peripheral (BreEStim) and Central Electrical Stimulation (tDCS) for Neuropathic Pain Management

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Oct 5, 2017
Registry last updated
Apr 27, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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