Trial Outcomes & Findings for Post-stroke Pain taVNS (NCT NCT06456385)

Last Updated: 2025-08-22

Results Overview

Using a quantitative sensory testing paradigm, the investigators will systematically determine information on thermal pain tolerance thresholds (degrees celsius) using a 30 × 30 mm thermode attached to the left forearm of participants.

Recruitment status

COMPLETED

Study phase

Target enrollment

15 participants

Primary outcome timeframe

assessed during and immediately after the single 30-minute taVNS session, Post 30-minute taVNS reported

Results posted on

2025-08-22

Participant Flow

Participant milestones

Participant milestones
Measure	Auricular Neurostimulation (Active) Participants will receive auricular stimulation of both the 15Hz on cymba conchae and 100Hz on tragus.	Auricular Neurostimulation (Sham) Participants will receive auricular stimulation of 15Hz on their earlobe.
Overall Study STARTED	7	8
Overall Study COMPLETED	7	8
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

One participant from the sham group did not complete the QST procedure correctly and was therefore excluded from the analysis.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Auricular Neurostimulation (Active) n=7 Participants Participants will receive auricular stimulation of both the 15Hz on cymba conchae and 100Hz on tragus.	Auricular Neurostimulation (Sham) n=8 Participants Participants will receive auricular stimulation of 15Hz on their earlobe.	Total n=15 Participants Total of all reporting groups
Age, Continuous	51.43 year STANDARD_DEVIATION 9.88 • n=7 Participants	61.38 year STANDARD_DEVIATION 8.43 • n=8 Participants	56.73 year STANDARD_DEVIATION 10.79 • n=15 Participants
Sex: Female, Male Female	6 Participants n=7 Participants	4 Participants n=8 Participants	10 Participants n=15 Participants
Sex: Female, Male Male	1 Participants n=7 Participants	4 Participants n=8 Participants	5 Participants n=15 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=7 Participants	0 Participants n=8 Participants	0 Participants n=15 Participants
Race (NIH/OMB) Asian	1 Participants n=7 Participants	0 Participants n=8 Participants	1 Participants n=15 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=7 Participants	0 Participants n=8 Participants	0 Participants n=15 Participants
Race (NIH/OMB) Black or African American	5 Participants n=7 Participants	3 Participants n=8 Participants	8 Participants n=15 Participants
Race (NIH/OMB) White	1 Participants n=7 Participants	5 Participants n=8 Participants	6 Participants n=15 Participants
Race (NIH/OMB) More than one race	0 Participants n=7 Participants	0 Participants n=8 Participants	0 Participants n=15 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=7 Participants	0 Participants n=8 Participants	0 Participants n=15 Participants
QST Thermal Pain Threshold	40.59 Celsius STANDARD_DEVIATION 4.51 • n=7 Participants • One participant from the sham group did not complete the QST procedure correctly and was therefore excluded from the analysis.	43.01 Celsius STANDARD_DEVIATION 2.44 • n=7 Participants • One participant from the sham group did not complete the QST procedure correctly and was therefore excluded from the analysis.	41.8 Celsius STANDARD_DEVIATION 3.75 • n=14 Participants • One participant from the sham group did not complete the QST procedure correctly and was therefore excluded from the analysis.
Subject Pain Rating	4.57 scale 0-10 STANDARD_DEVIATION 2.23 • n=7 Participants • One participant from the sham group did not complete the QST procedure correctly and was therefore excluded from the analysis.	4.14 scale 0-10 STANDARD_DEVIATION 2.61 • n=7 Participants • One participant from the sham group did not complete the QST procedure correctly and was therefore excluded from the analysis.	4.36 scale 0-10 STANDARD_DEVIATION 2.34 • n=14 Participants • One participant from the sham group did not complete the QST procedure correctly and was therefore excluded from the analysis.

PRIMARY outcome

Timeframe: assessed during and immediately after the single 30-minute taVNS session, Post 30-minute taVNS reported

Outcome measures

Outcome measures
Measure	Auricular Neurostimulation (Active) n=7 Participants Participants will receive auricular stimulation of both the 15Hz on cymba conchae and 100Hz on tragus.	Auricular Neurostimulation (Sham) n=7 Participants Participants will receive auricular stimulation of 15Hz on their earlobe.
Thermal Pain Threshold	41.84 Celsius Standard Deviation 5.14	42.51 Celsius Standard Deviation 2.66

SECONDARY outcome

Timeframe: assessed during and immediately after the single 30-minute taVNS session, Post 30-minute taVNS reported

Participants will rate their post-stroke upper extremity pain intensity before and after the taVNS using a standard numeric pain rating scale (from minimum 0 to maximum 10, higher scores mean more pain).

Outcome measures

Outcome measures
Measure	Auricular Neurostimulation (Active) n=7 Participants Participants will receive auricular stimulation of both the 15Hz on cymba conchae and 100Hz on tragus.	Auricular Neurostimulation (Sham) n=7 Participants Participants will receive auricular stimulation of 15Hz on their earlobe.
Subjective Pain Ratings	4.00 Scale 0-10 Standard Deviation 2.45	3.57 Scale 0-10 Standard Deviation 2.30

Adverse Events

Auricular Neurostimulation (Active)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Auricular Neurostimulation (Sham)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Xiaolong Peng

Medical University of South Carolina

Phone: 8437928642

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place