BreEStim and tDCS for Neuropathic Pain Management - Healthy Subjects

Pain Management Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03302780
• Other study ID #: HSC-MS-14-0564 Healthy
• Status: Completed
• Phase: N/A
• Start date: April 6, 2016
• Est. completion date: May 26, 2016

Study information

• Verified date: April 2021
• Source: The University of Texas Health Science Center, Houston
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: May 26, 2016
• Est. primary completion date: May 26, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Neuralgia
• Pain Management

Intervention

Device:
• BreEStim
BreEStim will applied for 10 to 20 minutes.
• tDCS active
tDCS will be applied for 20 minutes.
• tDCS sham

Locations

Country	Name	City	State
United States	TIRR	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
The University of Texas Health Science Center, Houston

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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