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

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ClinicalTrials.gov Identifier: NCT03302793
Recruitment Status : Completed
First Posted : October 5, 2017
Results First Posted : January 24, 2019
Last Update Posted : January 24, 2019
Sponsor:
Information provided by (Responsible Party):
Sheng Li, The University of Texas Health Science Center, Houston

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Single (Participant);   Primary Purpose: Treatment
Condition Pain Management
Interventions Device: BreEStim
Device: tDCS
Device: tDCS sham
Enrollment 12
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Sham tDCS and Then BreEStim; Then M1 tDCS and Then BreEstim M1 tDCS and Then BreEStim; Then Sham tDCS and Then BreEstim
Hide 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 6 6
Completed 6 4
Not Completed 0 2
Arm/Group Title All Participants
Hide 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 Number of Baseline Participants 12
Hide Baseline Analysis Population Description
2 subjects only finished Combined active tDCS (M1) and BreEStim section, but didn't attend the Sham tDCS and BreEStim section.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants
<=18 years
0
   0.0%
Between 18 and 65 years
12
 100.0%
>=65 years
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants
Female
5
  41.7%
Male
7
  58.3%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants
White
7
  58.3%
Black
2
  16.7%
Hispanic
3
  25.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 12 participants
12
 100.0%
1.Primary Outcome
Title Pain as Assessed by Visual Analogue Scale (VAS)
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
In the Sham tDCS and then BreEStim arm, only 10 participants were analyzed because 2 patients did not return for the second visit.
Arm/Group Title Sham tDCS and Then BreEStim Active tDCS (M1) and Then BreEStim
Hide 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.
Overall Number of Participants Analyzed 10 12
Mean (Standard Deviation)
Unit of Measure: units on a scale
baseline 6.0  (2.03) 5.9  (1.65)
After tDCS 5.4  (2.26) 5.3  (1.66)
After BreEstim 3.5  (1.91) 3.1  (2.08)
2.Secondary Outcome
Title Electrical Pain Threshold
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
In the Sham tDCS and then BreEStim arm, only 10 participants were analyzed because 2 patients did not return for the second visit.
Arm/Group Title Sham tDCS and Then BreEStim Active tDCS (M1) and Then BreEStim
Hide 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.
Overall Number of Participants Analyzed 10 12
Mean (Standard Deviation)
Unit of Measure: mA
Baseline 30.4  (25.53) 35.0  (26.04)
After tDCS 31.1  (27.05) 33.9  (26.37)
After BreEstim 34.5  (24.14) 35.2  (21.58)
3.Secondary Outcome
Title Electrical Sensation Threshold
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
In the Sham tDCS and then BreEStim arm, only 10 participants were analyzed because 2 patients did not return for the second visit.
Arm/Group Title Sham tDCS and Then BreEStim Active tDCS (M1) and Then BreEStim
Hide 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.
Overall Number of Participants Analyzed 10 12
Mean (Standard Deviation)
Unit of Measure: mA
Baseline 7.3  (2.41) 8.4  (2.59)
After tDCS 7.4  (2.84) 8.1  (2.51)
After BreEstim 7.3  (2.66) 8.3  (2.47)
Time Frame 16 hours after treatment
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Sham tDCS and Then BreEStim Active tDCS (M1) and Then BreEStim
Hide 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 Then BreEStim Active tDCS (M1) and Then BreEStim
Affected / at Risk (%) Affected / at Risk (%)
Total   0/10 (0.00%)   0/12 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Sham tDCS and Then BreEStim Active tDCS (M1) and Then BreEStim
Affected / at Risk (%) Affected / at Risk (%)
Total   0/10 (0.00%)   0/12 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Sham tDCS and Then BreEStim Active tDCS (M1) and Then BreEStim
Affected / at Risk (%) Affected / at Risk (%)
Total   0/10 (0.00%)   0/12 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Dr. Sheng Li
Organization: UTHealth
Phone: 713-797-7125
Responsible Party: Sheng Li, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier: NCT03302793     History of Changes
Other Study ID Numbers: HSC-MS-14-0564 SCI
First Submitted: October 1, 2017
First Posted: October 5, 2017
Results First Submitted: December 17, 2018
Results First Posted: January 24, 2019
Last Update Posted: January 24, 2019