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

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

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.

Study Overview

• Status: Completed
• Conditions: Pain Management
• Intervention / Treatment: Device: BreEStim; Device: tDCS; Device: tDCS sham

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • TIRR

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: BreEStim and tDCS sham, then combined BreEStim and tDCS; BreEStim is voluntary breathing controlled electrical stimulation.	Device: BreEStim; BreEStim will applied for 10 to 20 minutes.; Device: tDCS; tDCS will be applied for 20 minutes.; Device: tDCS sham
Experimental: Combined BreEStim and tDCS, then BreEStim and tDCS sham; BreEStim is voluntary breathing controlled electrical stimulation. tDCS is transcranial direct current stimulation.	Device: BreEStim; BreEStim will applied for 10 to 20 minutes.; Device: tDCS; tDCS will be applied for 20 minutes.; Device: tDCS sham

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain as Assessed by Visual Analogue Scale (VAS)	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.	baseline, 10 minutes after tDCS, 10 minutes after BreEstim

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Electrical Pain Threshold	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.	baseline, 10 minutes after tDCS, 10 minutes after BreEstim
Electrical Sensation Threshold	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.	baseline, 10 minutes after tDCS, 10 minutes after BreEstim

Collaborators and Investigators

• Sponsor: The University of Texas Health Science Center, Houston
• Investigators: Principal Investigator: Sheng Li, MD, PhD, The University of Texas Health Science Center, Houston

Publications and helpful links

General Publications

• Li S, Stampas A, Frontera J, Davis M, Li S. Combined transcranial direct current stimulation and breathing-controlled electrical stimulation for management of neuropathic pain after spinal cord injury. J Rehabil Med. 2018 Sep 28;50(9):814-820. doi: 10.2340/16501977-2379.

Study record dates

Study Major Dates

• Study Start: April 1, 2015
• Primary Completion (Actual): December 1, 2017
• Study Completion (Actual): December 1, 2017

Study Registration Dates

• First Submitted: October 1, 2017
• First Submitted That Met QC Criteria: October 1, 2017
• First Posted (Actual): October 5, 2017

Study Record Updates

• Last Update Posted (Actual): January 24, 2019
• Last Update Submitted That Met QC Criteria: January 16, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Pain; Neurologic Manifestations; Neuromuscular Diseases; Peripheral Nervous System Diseases; Neuralgia
• Other Study ID Numbers: HSC-MS-14-0564 SCI

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes