Combined Peripheral (BreEStim) and Central Electrical Stimulation (tDCS) for Neuropathic Pain Management - Spinal Cord Injury - Clinical Trial for Pain Management | NCT03302793

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Primary Purpose

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

BreEStim

tDCS

tDCS sham

About this trial

This is an interventional treatment trial for Pain Management

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

TIRR

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

BreEStim and tDCS sham, then combined BreEStim and tDCS

Combined BreEStim and tDCS, then BreEStim and tDCS sham

Arm Description

BreEStim is voluntary breathing controlled electrical stimulation.

BreEStim is voluntary breathing controlled electrical stimulation. tDCS is transcranial direct current stimulation.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

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.

Full Information

NCT ID

NCT03302793

First Posted

October 1, 2017

Last Updated

January 16, 2019

Sponsor

The University of Texas Health Science Center, Houston

1. Study Identification

Unique Protocol Identification Number

NCT03302793

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2019

Overall Recruitment Status

Completed

Study Start Date

April 2015 (undefined)

Primary Completion Date

December 2017 (Actual)

Study Completion Date

December 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

The University of Texas Health Science Center, Houston

4. Oversight

Studies a U.S. FDA-regulated Drug Product

No

Studies a U.S. FDA-regulated Device Product

Yes

Device Product Not Approved or Cleared by U.S. FDA

Yes

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pain Management

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

Participant

Allocation

Randomized

Enrollment

12 (Actual)

8. Arms, Groups, and Interventions

Arm Title

BreEStim and tDCS sham, then combined BreEStim and tDCS

Arm Type

Experimental

Arm Description

BreEStim is voluntary breathing controlled electrical stimulation.

Arm Title

Combined BreEStim and tDCS, then BreEStim and tDCS sham

Arm Type

Experimental

Arm Description

BreEStim is voluntary breathing controlled electrical stimulation. tDCS is transcranial direct current stimulation.

Intervention Type

Device

Intervention Name(s)

BreEStim

Intervention Description

BreEStim will applied for 10 to 20 minutes.

Intervention Type

Device

Intervention Name(s)

tDCS

Intervention Description

tDCS will be applied for 20 minutes.

Intervention Type

Device

Intervention Name(s)

tDCS sham

Primary Outcome Measure Information:

Title

Pain as Assessed by Visual Analogue Scale (VAS)

Description

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.

Time Frame

baseline, 10 minutes after tDCS, 10 minutes after BreEstim

Secondary Outcome Measure Information:

Title

Electrical Pain Threshold

Description

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.

Time Frame

baseline, 10 minutes after tDCS, 10 minutes after BreEstim

Title

Electrical Sensation Threshold

Description

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.

Time Frame

baseline, 10 minutes after tDCS, 10 minutes after BreEstim

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

No

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Sheng Li, MD, PhD

Organizational Affiliation

The University of Texas Health Science Center, Houston

Official's Role

Principal Investigator

Facility Information:

Facility Name

TIRR

City

Houston

State/Province

Texas

ZIP/Postal Code

77030

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

30132010

Citation

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.

Results Reference

result

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

Pain Management

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial