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Completed

NCT Number: NCT03302793

Combined Peripheral (BreEStim) and Central Electrical Stimulation (tDCS) for Neuropathic Pain Management - Spinal Cord Injury

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 spinal cord injury patients. Note that this study will also enroll healthy volunteers, 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: No

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

Inclusion criteria

  • between 18 and 75 years
  • male and female subjects
  • has neuropathic pain after traumatic spinal cord injury
  • has chronic pain, >3 months
  • is stable on oral pain medications at least two weeks. (patients are allowed to continue their pain medications, i.e., no change in pain medications.)

Exclusion criteria

  • currently adjusting oral pain medications for their neuropathic pain
  • have pain, but not neuropathic (e.g., from inflammation at the incision wound of the residual limb or neuroma)
  • 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

Device

tDCS will be applied for 20 minutes.

tDCS sham

Device

Primary outcomes

  1. Pain as Assessed by Visual Analogue Scale (VAS)

    Time frame: baseline, 10 minutes after tDCS, 10 minutes after BreEstim

    A Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured. It is often used in epidemiologic and clinical research to measure the intensity or frequency of various symptoms. To allow a continuous assessment of pain, VAS uses a 10 cm line labelled at '0' with 'no pain' and '10' with 'worst pain'. The line is marked at a point corresponding to the assessment of the pain.

Secondary outcomes

  1. Electrical Pain Threshold

    Time frame: baseline, 10 minutes after tDCS, 10 minutes after BreEstim

    Trimmed surface electrodes (1 inch by 1 inch) were used to examine electrical pain thresholds upon application of electrical stimulation (electrical stimulator 7SA, Digitimer). To measure electrical pain threshold, a pair of electrodes was placed next to each other centered on the thenar eminence (which is a group of muscles on the palm of the human hand at the base of the thumb); the intensity of electrical stimulation was started from the sensation threshold level (determined in outcome measure 3) and increased in steps of 1 mA; and subjects were instructed to close their eyes and to say ''yes'' when they first felt electrical stimulation painful. The electrical pain threshold is the mA level at which a participant first felt electrical stimulation painful. To improve consistency among subjects, they were advised that the pain threshold level was equivalent to 1 on the 0-10 VAS scale. Three repetitions were made and the average was used as the electrical pain threshold.

  2. Electrical Sensation Threshold

    Time frame: baseline, 10 minutes after tDCS, 10 minutes after BreEstim

    Trimmed surface electrodes (1 inch by 1 inch) were used to examine electrical sensation threshold upon application of electrical stimulation (electrical stimulator 7SA, Digitimer). To measure electrical sensation threshold, a pair of electrodes was placed next to each other centered on the thenar eminence (which is a group of muscles on the palm of the human hand at the base of the thumb); the intensity of electrical stimulation was started from zero and gradually increased in steps of 0.1 mA; and subjects were instructed to close their eyes and to say ''yes'' when they explicitly felt electrical stimulation. The electrical sensation threshold is the mA level at which a participant explicitly felt electrical stimulation. Three repetitions were made and the average was used as the electrical sensation threshold.

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
2015
Primary completion
2017
Study completion
2017
First posted
Oct 5, 2017
Registry last updated
Jan 24, 2019

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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