Upper Extremity DysfunctionNCT05943431
taVNS Paired With Motor Training for Upper-extremity Rehabilitation in Stroke Patients
A study testing paired taVNS and Unpaired taVNS in people with Upper Extremity Dysfunction and Stroke, run by Qiuyou Xie at 1 site in China.
Trial summary
Background: Recently, there has been increasing attention on the application of transcutaneous auricular vagus nerve stimulation (taVNS) in ischemic stroke. This innovative technique involves non-invasive electrical stimulation of the vagus nerve. A controlled study by Dawson et al. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Upper Extremity Dysfunction, Stroke
- What is being tested?
- paired taVNS and Unpaired taVNS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2023to 1 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients diagnosed with ischemic stroke according to a clinically qualified physician with reference to the Chinese Stroke Prevention and Control Guideline (2021).
- Patients in the acute/recovery phase (after 2 weeks of onset) with stable signs;
- No previous neuropsychiatric-related diseases;
- No significant impairment of cognitive function and able to cooperate in completing the corresponding rehabilitation training;
- With unilateral upper limb dysfunction;
- Patients who have not received various neuromodulation rehabilitation treatments;
- No contraindications to taVNS;
- Patients voluntarily cooperated with the study and signed an informed consent form.
Who cannot join
- Patients have other mental health disorders (dementia, Parkinson's disease, depression, schizophrenia, bipolar disorder, etc.)
- Patients have uncontrolled epilepsy, i.e., having had a seizure within 4 weeks prior to enrollment
- Patients have cardiac arrhythmias or other abnormalities
- Patients have a history of respiratory disease or disorder, including dyspnea and asthma;
- The presence of gastrointestinal disorders such as diarrhea and vomiting that make it difficult for the patient to cooperate
- Patients have a history of vasovagal syncope
Show all 10Show fewer
- Patients are under treatment with other neurostimulation/modulation
- The presence of severe spasticity, other serious injuries to the upper extremities, or other medical conditions
- Patients have difficulty in communication and understanding and inability to cooperate in completing the test;
- Women who are pregnant or breastfeeding.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Zhujiang Hospital of Southern Medical University
Guangzhou, Guangdong, 510280
Qiuyou Xie, PhD, +86 139 0301 9604, 764942251@qq.com
About this study
Official title: A Randomized, Double-blind Controlled Trial Investigating the Efficacy of Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) in Improving Upper Extremity Motor Function in Stroke Patients
Background: Recently, there has been increasing attention on the application of transcutaneous auricular vagus nerve stimulation (taVNS) in ischemic stroke. This innovative technique involves non-invasive electrical stimulation of the vagus nerve. A controlled study by Dawson et al. (2021), conducted using a randomized, double-blind approach, has demonstrated that vagus nerve stimulation (VNS) when paired with motor function training, can effectively promote the improvement of motor dysfunction in stroke patients. In the same year, the Food and Drug Administration approved the use of VNS, alongside motor rehabilitation training, for upper extremity dysfunction caused by stroke. However, it is worth noting that VNS requires surgical procedures with contraindications. Consequently, researchers are exploring taVNS as a potential alternative intervention. Compared to VNS, taVNS offers a low-risk and user-friendly intervention that eliminates the need for surgery and the associated postoperative complications. A recent meta-analysis has shown that the efficacy of taVNS in upper extremity rehabilitation for stroke patients can be comparable to that of VNS. Therefore, pairing taVNS with motor training holds promise as a valuable clinical tool for post-stroke rehabilitation.
Methods and Design: This study presents a protocol for a single-center randomized, double-blind controlled trial. A total of 150 participants will be enrolled and randomly assigned to one of three groups (Group 1, Group 2, or Group 3) in a 1:1:1 ratio. Each patient will undergo a total of 14 treatment sessions. In Group 1, patients will receive motor training paired with taVNS. In Group 2, patients will receive motor training and taVNS interventions, seperately. In Group 3, patients will receive motor training paired with sham taVNS. Primary and secondary outcome measures will be assessed at baseline and after taVNS treatment. The primary outcome will be determined by evaluating the behavioral response to treatment, using the Fugl-Meyer Assessment of Upper Extremity (FMA-UE).
Discussion: This study aims to elucidate the role of paired taVNS in the rehabilitation of upper extremity dysfunction in stroke patients. The researchers propose a novel approach by pairing taVNS with individualized training actions, utilizing electromyography (EMG) during motor training to precisely trigger taVNS.
- Conditions
- Upper Extremity Dysfunction, Stroke
- Being tested
- paired taVNS, Unpaired taVNS, Sham taVNS
- Keywords
- Upper Extremity Dysfunction, Ischemic Stroke, Transcutaneous auricular vagus nerve stimulation, Electromyography
- Medical subject headings
- Stroke, Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
paired taVNSDevice
The stimulator will be placed on the left ear of the patient. While the patient performs the action training, the EMG signal feature evoked by the action will trigger an electrical stimulation of the transcutaneous auricular vagus nerve. The amplitude of the electrical stimulation will be adjusted under the patient's pain threshold. The intervention will be performed daily for 14 days.
Unpaired taVNSDevice
The stimulator will be placed on the patient's left ear. Patients will receive taVNS with pulses every 5-7 seconds. Following the stimulation, motor training will be performed. The motor training will be identical to that of the paired group. The amplitude of the electrical stimulation will be adjusted under the patient's pain threshold. The intervention will be performed daily for 14 days.
Sham taVNSDevice
The stimulator will be placed on the patient's left ear. The amplitude of the electrical stimulation will be adjusted at 0 mA. The intervention will be performed daily for 14 days.
| Study group | Role | What they receive |
|---|---|---|
| Paired taVNS | Experimental | Upper extremity motor rehabilitation training will be paired with taVNS. Receives: Device: paired taVNS |
| Unpaired taVNS | Active comparator | Unpaired transcutaneous vagus nerve stimulation for upper limb motor rehabilitation will be administered. Receives: Device: Unpaired taVNS |
| Sham taVNS | Sham comparator | Upper limb motor rehabilitation training will be paired with sham-stimulation. Receives: Device: Sham taVNS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes from Baseline Fugl-Meyer Assessment of Upper Extremity (FMA-UE) Scores
The Fugl-Meyer Assessment - Upper Extremity (FMA-UE) is a stroke-specific assessment that measures performance at the body function/impairment domain. It uses an ordinal scale for scoring 33 items for the upper limb function with a total possible score of 66. The FMA-UE is one of the most widely used quantitative measures of motor impairment after stroke. Studies have shown excellent inter-rater, and intra-rater reliability, and construct validity of FMA-UE. In addition, empirical evidence suggests that the FMA-UE is responsive to the change in rehabilitation. Higher scores are indicative of better outcomes.
The primary outcome measures are as follows:
- Difference in the changes from baseline FMA-UE scores between paired taVNS and shame taVNS groups.
- Difference in the changes from baseline FMA-UE scores between unpaired taVNS and shame taVNS groups.
- Difference in the changes from baseline FMA-UE scores between paired taVNS and unpaired taVNS groups.
Measured: Immediately after 14 days' sessions
Secondary outcomes (6)
Changes from Baseline Wolf motor function test (WMFT)
The Wolf motor function test (WMFT) is a widely used measure for upper extremity motor abilities. It uses a 6-point ordinal scale for scoring 17 items with a total core of 85. Higher scores are indicative of better outcomes.
We will compare the differences in the changes from baseline WMFT scores between paired taVNS and shame taVNS groups, between unpaired taVNS and shame taVNS groups, and between paired taVNS and unpaired taVNS groups.
Measured: Immediately after 14 days' sessions
Changes from Baseline Brunnstrom recovery stages (BRS)
The Brunnstrom recovery stages (BRS) is a measure for assessing motor function. The BRS contains 3 items rated on a 6-level Likert-type scale. Higher scores are indicative of better outcomes.
We will compare the differences in the changes from baseline BRS scores between paired taVNS and shame taVNS groups, between unpaired taVNS and shame taVNS groups, and between paired taVNS and unpaired taVNS groups.
Measured: Immediately after 14 days' sessions
Changes from Baseline Barthel Index (BI)
The Barthel Index (BI) is a measure of independence in the activities of daily living (ADLs). The BI includes the 10 ADLs with a total score of 100. Higher scores are indicative of better outcomes.
We will compare the differences in the changes from baseline BI scores between paired taVNS and shame taVNS groups, between unpaired taVNS and shame taVNS groups, and between paired taVNS and unpaired taVNS groups.
Measured: Immediately after 14 days' sessions
Changes from Baseline Hong Kong version of the Functional Test for the Hemiplegic Upper Extremity (FTHUE-HK)
The Hong Kong version of the Functional Test for the Hemiplegic Upper Extremity (FTHUE-HK) is another measure for ADL. It uses a 7-point ordinal scale for scoring 12 items with a total score of 84. Higher scores are indicative of better outcomes.
We will compare the differences in the changes from baseline FTHUE-HK scores between paired taVNS and shame taVNS groups, between unpaired taVNS and shame taVNS groups, and between paired taVNS and unpaired taVNS groups.
Measured: Immediately after 14 days' sessions
Changes from Baseline EMG features
EMG will be acquired from 2 channels on the upper limb. When participants perform motor training, the peak amplitudes and the zero crossing rate of EMG signals at the time domain and the relative spectral power (RSP) of EMG signals at 20 to 200 Hz will be calculated on-line.
- Difference in the changes from baseline EMG features between paired taVNS and shame taVNS groups.
- Difference in the changes from baseline EMG features scores between unpaired taVNS and shame taVNS groups.
- Difference in the changes from baseline EMG features scores between paired taVNS and unpaired taVNS groups.
Measured: Immediately after 14 days' sessions
Changes from Baseline EEG features
EEG will be acquired from 66 channels following the international 10-20 System for 10 mins. The relative spectral power (RSP) of participants will be calculated by the selected artifact-free EEG epochs at five frequency bands: δ (1-4 Hz), θ (4-8 Hz), α (8-13 Hz), β (13-30 Hz), and γ (30-45 Hz). The investigators will perform off-line analysis to calculate RSP.
- Difference in the changes from baseline EEG features between paired taVNS and shame taVNS groups.
- Difference in the changes from baseline EEG features scores between unpaired taVNS and shame taVNS groups.
- Difference in the changes from baseline EEG features scores between paired taVNS and unpaired taVNS groups.
Measured: Immediately after 14 days' sessions
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2023
- Study start1 Aug 2023
- Primary completion1 Jul 2025 (estimated)
- Study completion1 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Upper Extremity DysfunctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qiuyou Xie
- Sponsor type
- University, hospital or other
- Collaborators
- Zhuhai Fudan Innovation Institute, BrainClos Co., LTD.
- Responsible party
- Sponsor-investigator, Qiuyou Xie, Zhujiang Hospital
- Investigators
- Qiuyou Xie, PhD, Principal investigator, Southern Medical University, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05943431
- Sponsor's protocol ID
- L20230613
- Status last verified
- Jan 2024
- First submitted
- 25 Jun 2023
- Last updated
- 12 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Dawson J, Liu CY, Francisco GE, Cramer SC, Wolf SL, Dixit A, Alexander J, Ali R, Brown BL, Feng W, DeMark L, Hochberg LR, Kautz SA, Majid A, O'Dell MW, Pierce D, Prudente CN, Redgrave J, Turner DL, Engineer ND, Kimberley TJ. Vagus nerve stimulation paired with rehabilitation for upper limb motor function after ischaemic stroke (VNS-REHAB): a randomised, blinded, pivotal, device trial. Lancet. 2021 Apr 24;397(10284):1545-1553. doi: 10.1016/S0140-6736(21)00475-X.
PubMed 33894832Liu Y, Zhang L, Zhang X, Ma J, Jia G. Effect of Combined Vagus Nerve Stimulation on Recovery of Upper Extremity Function in Patients with Stroke: A Systematic Review and Meta-Analysis. J Stroke Cerebrovasc Dis. 2022 Jun;31(6):106390. doi: 10.1016/j.jstrokecerebrovasdis.2022.106390. Epub 2022 Mar 22.
PubMed 35334250De Smet S, Ottaviani C, Verkuil B, Kappen M, Baeken C, Vanderhasselt MA. Effects of non-invasive vagus nerve stimulation on cognitive and autonomic correlates of perseverative cognition. Psychophysiology. 2023 Jun;60(6):e14250. doi: 10.1111/psyp.14250. Epub 2023 Jan 22.
PubMed 36683127Chang JL, Coggins AN, Saul M, Paget-Blanc A, Straka M, Wright J, Datta-Chaudhuri T, Zanos S, Volpe BT. Transcutaneous Auricular Vagus Nerve Stimulation (tAVNS) Delivered During Upper Limb Interactive Robotic Training Demonstrates Novel Antagonist Control for Reaching Movements Following Stroke. Front Neurosci. 2021 Nov 25;15:767302. doi: 10.3389/fnins.2021.767302. eCollection 2021.
PubMed 34899170Cook DN, Thompson S, Stomberg-Firestein S, Bikson M, George MS, Jenkins DD, Badran BW. Design and validation of a closed-loop, motor-activated auricular vagus nerve stimulation (MAAVNS) system for neurorehabilitation. Brain Stimul. 2020 May-Jun;13(3):800-803. doi: 10.1016/j.brs.2020.02.028. Epub 2020 Feb 27.
PubMed 32289710Monge-Pereira E, Molina-Rueda F, Rivas-Montero FM, Ibanez J, Serrano JI, Alguacil-Diego IM, Miangolarra-Page JC. Electroencephalography as a post-stroke assessment method: An updated review. Neurologia. 2017 Jan-Feb;32(1):40-49. doi: 10.1016/j.nrl.2014.07.002. Epub 2014 Oct 5. English, Spanish.
PubMed 25288536Badran BW, Peng X, Baker-Vogel B, Hutchison S, Finetto P, Rishe K, Fortune A, Kitchens E, O'Leary GH, Short A, Finetto C, Woodbury ML, Kautz S. Motor Activated Auricular Vagus Nerve Stimulation as a Potential Neuromodulation Approach for Post-Stroke Motor Rehabilitation: A Pilot Study. Neurorehabil Neural Repair. 2023 Jun;37(6):374-383. doi: 10.1177/15459683231173357. Epub 2023 May 20.
PubMed 37209010
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind Controlled Trial Investigating the Efficacy of Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) in Improving Upper Extremity Motor Function in Stroke Patients
- ClinicalTrials.gov ID
- NCT05943431
- Acronym / sponsor ID
- L20230613
- Conditions
- Upper Extremity Dysfunction, Stroke
- Keywords
- Upper Extremity Dysfunction, Ischemic Stroke, Transcutaneous auricular vagus nerve stimulation, Electromyography
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Qiuyou XieUniversity, hospital or other
- Collaborators
- Zhuhai Fudan Innovation Institute, BrainClos Co., LTD.
- Study start
- 1 Aug 2023 (actual)
- Primary completion
- 1 Jul 2025 (estimated)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 13 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Background: Recently, there has been increasing attention on the application of transcutaneous auricular vagus nerve stimulation (taVNS) in ischemic stroke. This innovative technique involves non-invasive electrical stimulation of the vagus nerve. A controlled study by Dawson et al. (2021), conducted using a randomized, double-blind approach, has demonstrated that vagus nerve stimulation (VNS) when paired with motor function training, can effectively promote the improvement of motor dysfunction in stroke patients. In the same year, the Food and Drug Administration approved the use of VNS, alongside motor rehabilitation training, for upper extremity dysfunction caused by stroke. However, it is worth noting that VNS requires surgical procedures with contraindications. Consequently, researchers are exploring taVNS as a potential alternative intervention. Compared to VNS, taVNS offers a low-risk and user-friendly intervention that eliminates the need for surgery and the associated postoperative complications. A recent meta-analysis has shown that the efficacy of taVNS in upper extremity rehabilitation for stroke patients can be comparable to that of VNS. Therefore, pairing taVNS with motor training holds promise as a valuable clinical tool for post-stroke rehabilitation.
Methods and Design: This study presents a protocol for a single-center randomized, double-blind controlled trial. A total of 150 participants will be enrolled and randomly assigned to one of three groups (Group 1, Group 2, or Group 3) in a 1:1:1 ratio. Each patient will undergo a total of 14 treatment sessions. In Group 1, patients will receive motor training paired with taVNS. In Group 2, patients will receive motor training and taVNS interventions, seperately. In Group 3, patients will receive motor training paired with sham taVNS. Primary and secondary outcome measures will be assessed at baseline and after taVNS treatment. The primary outcome will be determined by evaluating the behavioral response to treatment, using the Fugl-Meyer Assessment of Upper Extremity (FMA-UE).
Discussion: This study aims to elucidate the role of paired taVNS in the rehabilitation of upper extremity dysfunction in stroke patients. The researchers propose a novel approach by pairing taVNS with individualized training actions, utilizing electromyography (EMG) during motor training to precisely trigger taVNS.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Paired taVNS | Experimental | Device: paired taVNSUpper extremity motor rehabilitation training will be paired with taVNS. |
| Unpaired taVNS | Active comparator | Device: Unpaired taVNSUnpaired transcutaneous vagus nerve stimulation for upper limb motor rehabilitation will be administered. |
| Sham taVNS | Sham comparator | Device: Sham taVNSUpper limb motor rehabilitation training will be paired with sham-stimulation. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patients diagnosed with ischemic stroke according to a clinically qualified physician with reference to the Chinese Stroke Prevention and Control Guideline (2021).
- Patients in the acute/recovery phase (after 2 weeks of onset) with stable signs;
- No previous neuropsychiatric-related diseases;
- No significant impairment of cognitive function and able to cooperate in completing the corresponding rehabilitation training;
- With unilateral upper limb dysfunction;
Key exclusion criteria (10 listed)
- Patients have other mental health disorders (dementia, Parkinson's disease, depression, schizophrenia, bipolar disorder, etc.)
- Patients have uncontrolled epilepsy, i.e., having had a seizure within 4 weeks prior to enrollment
- Patients have cardiac arrhythmias or other abnormalities
- Patients have a history of respiratory disease or disorder, including dyspnea and asthma;
- The presence of gastrointestinal disorders such as diarrhea and vomiting that make it difficult for the patient to cooperate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| paired taVNSThe stimulator will be placed on the left ear of the patient. While the patient performs the action training, the EMG signal feature evoked by the action will trigger an electrical stimulation of the transcutaneous auricular vagus nerve. The amplitude of the electrical stimulation will be adjusted under the patient's pain threshold. The intervention will be performed daily for 14 days. | Device | Paired taVNS |
| Unpaired taVNSThe stimulator will be placed on the patient's left ear. Patients will receive taVNS with pulses every 5-7 seconds. Following the stimulation, motor training will be performed. The motor training will be identical to that of the paired group. The amplitude of the electrical stimulation will be adjusted under the patient's pain threshold. The intervention will be performed daily for 14 days. | Device | Unpaired taVNS |
| Sham taVNSThe stimulator will be placed on the patient's left ear. The amplitude of the electrical stimulation will be adjusted at 0 mA. The intervention will be performed daily for 14 days. | Device | Sham taVNS |
Primary outcome
Changes from Baseline Fugl-Meyer Assessment of Upper Extremity (FMA-UE) Scores
Time frame: Immediately after 14 days' sessions
The Fugl-Meyer Assessment - Upper Extremity (FMA-UE) is a stroke-specific assessment that measures performance at the body function/impairment domain. It uses an ordinal scale for scoring 33 items for the upper limb function with a total possible score of 66. The FMA-UE is one of the most widely used quantitative measures of motor impairment after stroke. Studies have shown excellent inter-rater, and intra-rater reliability, and construct validity of FMA-UE. In addition, empirical evidence suggests that the FMA-UE is responsive to the change in rehabilitation. Higher scores are indicative of better outcomes. The primary outcome measures are as follows: 1. Difference in the changes from baseline FMA-UE scores between paired taVNS and shame taVNS groups. 2. Difference in the changes from baseline FMA-UE scores between unpaired taVNS and shame taVNS groups. 3. Difference in the changes from baseline FMA-UE scores between paired taVNS and unpaired taVNS groups.
6 secondary outcomes
Changes from Baseline Wolf motor function test (WMFT)
Time frame: Immediately after 14 days' sessions
Changes from Baseline Brunnstrom recovery stages (BRS)
Time frame: Immediately after 14 days' sessions
Changes from Baseline Barthel Index (BI)
Time frame: Immediately after 14 days' sessions
Changes from Baseline Hong Kong version of the Functional Test for the Hemiplegic Upper Extremity (FTHUE-HK)
Time frame: Immediately after 14 days' sessions
Changes from Baseline EMG features
Time frame: Immediately after 14 days' sessions
Changes from Baseline EEG features
Time frame: Immediately after 14 days' sessions
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2024.
- Background: PubMed 33894832Dawson J, Liu CY, Francisco GE, Cramer SC, Wolf SL, Dixit A, Alexander J, Ali R, Brown BL, Feng W, DeMark L, Hochberg LR, Kautz SA, Majid A, O'Dell MW, Pierce D, Prudente CN, Redgrave J, Turner DL, Engineer ND, Kimberley TJ. Vagus nerve stimulation paired with rehabilitation for upper limb motor function after ischaemic stroke (VNS-REHAB): a randomised, blinded, pivotal, device trial. Lancet. 2021 Apr 24;397(10284):1545-1553. doi: 10.1016/S0140-6736(21)00475-X.
- Background: PubMed 35334250Liu Y, Zhang L, Zhang X, Ma J, Jia G. Effect of Combined Vagus Nerve Stimulation on Recovery of Upper Extremity Function in Patients with Stroke: A Systematic Review and Meta-Analysis. J Stroke Cerebrovasc Dis. 2022 Jun;31(6):106390. doi: 10.1016/j.jstrokecerebrovasdis.2022.106390. Epub 2022 Mar 22.
- Background: PubMed 36683127De Smet S, Ottaviani C, Verkuil B, Kappen M, Baeken C, Vanderhasselt MA. Effects of non-invasive vagus nerve stimulation on cognitive and autonomic correlates of perseverative cognition. Psychophysiology. 2023 Jun;60(6):e14250. doi: 10.1111/psyp.14250. Epub 2023 Jan 22.
- Background: PubMed 34899170Chang JL, Coggins AN, Saul M, Paget-Blanc A, Straka M, Wright J, Datta-Chaudhuri T, Zanos S, Volpe BT. Transcutaneous Auricular Vagus Nerve Stimulation (tAVNS) Delivered During Upper Limb Interactive Robotic Training Demonstrates Novel Antagonist Control for Reaching Movements Following Stroke. Front Neurosci. 2021 Nov 25;15:767302. doi: 10.3389/fnins.2021.767302. eCollection 2021.
- Background: PubMed 32289710Cook DN, Thompson S, Stomberg-Firestein S, Bikson M, George MS, Jenkins DD, Badran BW. Design and validation of a closed-loop, motor-activated auricular vagus nerve stimulation (MAAVNS) system for neurorehabilitation. Brain Stimul. 2020 May-Jun;13(3):800-803. doi: 10.1016/j.brs.2020.02.028. Epub 2020 Feb 27.
- Background: PubMed 25288536Monge-Pereira E, Molina-Rueda F, Rivas-Montero FM, Ibanez J, Serrano JI, Alguacil-Diego IM, Miangolarra-Page JC. Electroencephalography as a post-stroke assessment method: An updated review. Neurologia. 2017 Jan-Feb;32(1):40-49. doi: 10.1016/j.nrl.2014.07.002. Epub 2014 Oct 5. English, Spanish.
- Background: PubMed 37209010Badran BW, Peng X, Baker-Vogel B, Hutchison S, Finetto P, Rishe K, Fortune A, Kitchens E, O'Leary GH, Short A, Finetto C, Woodbury ML, Kautz S. Motor Activated Auricular Vagus Nerve Stimulation as a Potential Neuromodulation Approach for Post-Stroke Motor Rehabilitation: A Pilot Study. Neurorehabil Neural Repair. 2023 Jun;37(6):374-383. doi: 10.1177/15459683231173357. Epub 2023 May 20.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Qiuyou Xie, PhD principal investigator
Southern Medical University, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing paired taVNS and Unpaired taVNS in people with Upper Extremity Dysfunction and Stroke, run by Qiuyou Xie at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xue-Zhen XIAO, PhD (+8613425122570, xuezhenxiao@brainclos.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes from Baseline Fugl-Meyer Assessment of Upper Extremity (FMA-UE) Scores (time frame: Immediately after 14 days' sessions). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05943431, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2024.