BreEStim and tDCS for Neuropathic Pain Management - Healthy Subjects

• Sponsor: The University of Texas Health Science Center, Houston (Other)
• Overall Status: Completed
• CT.gov ID: NCT03302780
• Collaborator: (none)
• Enrollment: 6
• Location: 1
• Arms: 2
• Actual Duration (Months): 1.6
• Patients Per Site Per Month: 3.7

Study Details

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 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.

Condition or Disease	Intervention/Treatment	Phase
Pain Management	Device: BreEStim; Device: tDCS active; Device: tDCS sham	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 6 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: Combined Peripheral (BreEStim) and Central Electrical Stimulation (tDCS) for Neuropathic Pain Management
• Actual Study Start Date: Apr 6, 2016
• Actual Primary Completion Date: May 26, 2016
• Actual Study Completion Date: May 26, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Sham tDCS and BreEStim This arm includes a 20-min sham tDCS to the current dominant primary motor cortex (M1), followed by a 20-min BreEStim to the median nerve (160 times) transcutaneously on the current dominant side.	Device: BreEStim; BreEStim will applied for 10 to 20 minutes.; Device: tDCS sham
Experimental: active tDCS (M1) and BreEStim This arm includes a 20-min active tDCS to the current dominant primary motor cortex (M1), followed by a 20-min BreEStim to the median nerve (160 times) transcutaneously on the current dominant side.	Device: BreEStim; BreEStim will applied for 10 to 20 minutes.; Device: tDCS active; tDCS will be applied for 20 minutes.

Outcome Measures

Primary Outcome Measures

1. Electrical Pain Threshold (EPT) [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) [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	TIRR	Houston	Texas	United States	77030

Sponsors and Collaborators

• The University of Texas Health Science Center, Houston

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Sheng Li, PhysicianProfessor, The University of Texas Health Science Center, Houston
• ClinicalTrials.gov Identifier: NCT03302780
• Other Study ID Numbers: HSC-MS-14-0564 Healthy
• First Posted: Oct 5, 2017
• Last Update Posted: Apr 27, 2021
• Last Verified: Apr 1, 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Additional relevant MeSH terms: Neuralgia

Study Results

Participant Flow

Arm/Group Title	Sham tDCS and BreEStim; Then M1 tDCS and BreEstim	M1 tDCS and BreEStim; Then Sham tDCS and BreEstim
Arm/Group Description	This study has a single-blinded, single-center, sham-controlled, crossover design. It included 2 separate visits, each with either a 20-min sham tDCS or M1 tDCS to the current dominant primary motor cortex(M1), both followed by a 20-min BreEStim to the median nerve(160 times) transcutaneously on the current dominant side.	This study has a single-blinded, single-center, sham-controlled, crossover design. It included 2 separate visits, each with either a 20-min sham tDCS or M1 tDCS to the current dominant primary motor cortex(M1), both followed by a 20-min BreEStim to the median nerve(160 times) transcutaneously on the current dominant side.
Period Title: Overall Study
STARTED	3	3
COMPLETED	3	3
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	All Participants
Arm/Group Description	This study has a single-blinded, single-center, sham-controlled, crossover design. It included 2 separate visits, each with either a 20-min sham tDCS or M1 tDCS to the current dominant primary motor cortex(M1), both followed by a 20-min BreEStim to the median nerve(160 times) transcutaneously on the current dominant side.
Overall Participants	6
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	6 100%
>=65 years	0 0%
Age (years) [Mean (Full Range) ]
Mean (Full Range) [years]	34
Sex: Female, Male (Count of Participants)
Female	1 16.7%
Male	5 83.3%
Region of Enrollment (participants) [Number]
United States	6 100%

Outcome Measures

1. Primary Outcome

Title	Electrical Pain Threshold (EPT)
Description	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.
Time Frame	baseline, 10 minutes after tDCS, 10 minutes after BreEstim

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Sham tDCS and BreEStim	Active tDCS (M1) and BreEStim
Arm/Group Description	This study has a single-blinded, single-center, sham-controlled, crossover design. It included a 20-min sham tDCS to the current dominant primary motor cortex(M1), followed by a 20-min BreEStim to the median nerve(160 times) transcutaneously on the current dominant side.	This study has a single-blinded, single-center, sham-controlled, crossover design. It included a 20-min active tDCS to the current dominant primary motor cortex(M1), followed by a 20-min BreEStim to the median nerve(160 times) transcutaneously on the current dominant side.
Measure Participants	6	6
Baseline	23.83 (6.79)	22.41 (4.67)
After tDCS	24.08 (7.68)	20.41 (3.01)
After BreEstim	26.70 (7.68)	23.77 (6.78)

2. Primary Outcome

Title	Electrical Sensation Threshold (EST)
Description	Electrical Detection Threshold (EDT) is a type of Quantitative sensory test that assesses the lowest electrical current that first evokes an electrical sensation.
Time Frame	baseline, 10 minutes after tDCS, 10 minutes after BreEstim

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Sham tDCS and BreEStim	Active tDCS (M1) and BreEStim
Arm/Group Description	This study has a single-blinded, single-center, sham-controlled, crossover design. It included a 20-min sham tDCS to the current dominant primary motor cortex(M1), followed by a 20-min BreEStim to the median nerve(160 times) transcutaneously on the current dominant side.	This study has a single-blinded, single-center, sham-controlled, crossover design. It included a 20-min active tDCS to the current dominant primary motor cortex(M1), followed by a 20-min BreEStim to the median nerve(160 times) transcutaneously on the current dominant side.
Measure Participants	6	6
Baseline	4.05 (1.07)	3.54 (0.92)
After tDCS	3.99 (0.86)	3.39 (0.53)
After BreEstim	3.95 (0.74)	3.59 (0.64)

Adverse Events

Time Frame	1 hour after treatment
Arm/Group Title	Sham tDCS and BreEStim		Active tDCS (M1) and BreEStim
Arm/Group Description	This study has a single-blinded, single-center, sham-controlled, crossover design. It included a 20-min sham tDCS to the current dominant primary motor cortex(M1), followed by a 20-min BreEStim to the median nerve(160 times) transcutaneously on the current dominant side.		This study has a single-blinded, single-center, sham-controlled, crossover design. It included a 20-min active tDCS to the current dominant primary motor cortex(M1), followed by a 20-min BreEStim to the median nerve(160 times) transcutaneously on the current dominant side.
All Cause Mortality
	Sham tDCS and BreEStim		Active tDCS (M1) and BreEStim
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/6 (0%)		0/6 (0%)
Serious Adverse Events
	Sham tDCS and BreEStim		Active tDCS (M1) and BreEStim
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/6 (0%)		0/6 (0%)
Other (Not Including Serious) Adverse Events
	Sham tDCS and BreEStim		Active tDCS (M1) and BreEStim
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/6 (0%)		0/6 (0%)

Limitations/Caveats

Study stopped early, and small numbers of subjects analyzed.

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.