Motor ImpairmentINPULSENCT06895005
Transcutaneous Auricular Vagus Nerve Stimulation in Patients With Stroke
A study testing Transcutaneous auricular vagus nerve stimulation + rehabilitation therapy in people with Motor Impairment and Motor Impairments, run by Fundación Cardiovascular de Colombia at 1 site in Colombia.
Trial summary
This study will evaluate the effects of transcutaneous vagus nerve stimulation in combination with physical rehabilitation on upper limb motor function of patients with stroke. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Motor Impairment, Motor Impairments, Stroke
- What is being tested?
- Transcutaneous auricular vagus nerve stimulation + rehabilitation therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteColombia
- Study dates
- 1 Apr 2025to 24 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age >18 years and <75 years
- Unilateral supratentorial ischemic stroke that occurred at least 7 days but not more 30 days before enrollment.
- Modified Rankin Scale between 0 and 1 before stroke
- Contralesional UL motor impairment defined by NIHSS item 5 score ≥ 1 to ≤ 3.
- Ability to provide written informed consent.
- Hemodynamically stable patients.
- Patients residing in the metropolitan area of Bucaramanga.
Who cannot join
- Significant cognitive or language impairment that would interfere with study participation or informed consent. This criterion will be defined by NIHSS item 1a-c score > 2, item 9 score > 1, item 11 score = 2.
- Medical conditions that could interfere with study participation, for example ear infections or skin wounds.
- Bradycardia (< 50 bpm) or hypotension (< 90/60 mmHg)
- Significant pre-existing disability
- History of stroke
- History of cardiac arrhythmia
Show all 13Show fewer
- History of severe head trauma, brain surgery, deep brain stimulation, or brain injuries of other etiologies.
- Pregnant or planning on becoming pregnant or breastfeeding during the study period.
- Medical or mental instability (diagnosis of personality disorder, psychosis, or substance abuse) that would prevent subject from meeting protocol timeline.
- Subjects who are currently in another clinical trial or plan to do so during the study period.
- Patient receiving any therapy at study entry that would interfere with VNS (e.g., drugs that interfere with neurotransmitter mechanisms: anticholinergics, adrenergic blockers, etc.).
- Prior injury to vagus nerve.
- Any other implanted device such as a pacemaker or other neurostimulator; any other investigational device or drug.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sandra M Sanabria, Bacteriologist, PhD contact
Colombia1 site
Neurology Center of Excellence - Hospital Internacional de Colombia - Fundación cardiovascular de Colombia
Piedecuesta, Santander Department
Nicolas Peña, Physiotherapist, 3008682154, nicolasnovoa2000@gmail.com
Tony F Álvarez, MD - Neurologist
About this study
Official title: Effectiveness of Transcutaneous Auricular Vagus Nerve Stimulation on Upper Limb Motor Recovery After Stroke
This study will evaluate the effects of transcutaneous vagus nerve stimulation in combination with physical rehabilitation on upper limb motor function of patients with stroke.
Read the detailed description
Stroke is a neurological condition caused by vascular problems such as cerebral infarction and/or intracerebral or subarachnoid hemorrhage(1). In 2019, more than 12 million strokes occurred worldwide, making it one of the leading causes of morbidity.
Motor impairment is considered one of the main problems resulting from this condition(2). Recovery of motor function occurs spontaneously during the first months after stroke(3) as a result of brain plasticity processes in the sensory and motor systems(4). It is estimated that 50 to 75% of patients with stroke persist with significant motor sequelae limiting daily activities(5).
Recently, Vagus Nerve Stimulation (VNS) has been proposed as an intervention that could have beneficial effects in the recovery of motor function in these patients, since it contributes to the generation of adaptive neuroplasticity and the activation of neuromodulators that reduce brain inflammation(6).
VNS has mainly been administered by using implanted electrodes, but more recently, a non-invasive technique, known as transcutaneous VNS (cervical or auricular) has been proposed. VNS has traditionally required the implantation of an electrical pulse generator at the left subclavicular level, which is connected to electrodes in the left cervical branch of the vagus nerve(7). Its insertion is performed by a surgical procedure, which presents a higher risk of adverse events(8), the most frequent being dysphonia during stimulation, due to its proximity to the laryngeal nerve(9). On the other hand, transcutaneous VNS works through the placement of non-invasive electrodes on the neck or auricle for stimulation of the cervical or auricular branch of the vagus nerve respectively(7). Transcutaneous VNS has a lower risk of adverse events, is reversible and easy to implement(7). In addition, experimental evidence suggests that the effects of transcutaneous VNS on brain function are comparable to those obtained with VNS(8).
This study will evaluate the effects of transcutaneous vagus nerve stimulation (tVNS) in combination with physical rehabilitation on upper limb motor function of patients with stroke. Thirty patients with ischemic stroke will be included in the study. Subjects will be randomized to tVNS + physical rehabilitation or sham stimulation + physical rehabilitation. Therapy sessions will be performed 3 times a week for six consecutive weeks. Efficacy will be evaluated by assessing the change in motor function of the upper limb, the next day and 30 days after the end of the intervention. The motor function of the upper limb will be assessed by means of the Fugl-Meyer scale score.
- Conditions
- Motor Impairment, Motor Impairments, Stroke, Stroke; Sequelae, Stroke, Ischemic
- Being tested
- Transcutaneous auricular vagus nerve stimulation + rehabilitation therapy, sham stimulation + rehabilitation therapy
- Keywords
- Stroke, Vagus nerve, Vagus nerve stimulation, Transcutaneous vagus nerve stimulation, Rehabilitation
- 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.
Transcutaneous auricular vagus nerve stimulation + rehabilitation therapyDevice
Transcutaneous auricular vagus nerve stimulation using INPULSE 3 times a week for six consecutive weeks. The stimulation parameters will be a frequency of 30Hz with a pulse width of 300 us and a stimulation time of 1.5 seconds for each respiratory cycle. The electrical current will be gradually increased to a maximum of 5 mA (0.25-mA increments) to allow adaptation to the stimulation until a comfortable tolerance level is achieved. Patients will receive physical rehabilitation therapy during stimulation, which will include reaching and grasping exercises, gross movements, turning objects, simulating specific tasks, inserting objects, opening and closing containers.
sham stimulation + rehabilitation therapyOther
Patients will receive physical rehabilitation therapy during placebo stimulation (No electrical stimulation), including reaching and grasping exercises, gross movements, turning objects, simulating specific tasks, inserting objects, opening and closing containers.
| Study group | Role | What they receive |
|---|---|---|
| Transcutaneous auricular vagus nerve stimulation + rehabilitation therapy | Experimental | Not described Receives: Device: Transcutaneous auricular vagus nerve stimulation + rehabilitation therapy |
| Sham stimulation + rehabilitation therapy | Sham comparator | Not described Receives: Other: sham stimulation + rehabilitation therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Motor function of the upper limb
Efficacy will be assessed by evaluating the change in motor function of the upper limb, the next day and 30 days after the end of the intervention. The motor function of the upper limb will be assessed by means of the Fugl-Meyer scale score. The motor function component ranges from 0 to 100, where higher scores indicate better motor recovery.
Measured: 1 day and 30 days after the end of the intervention
Arm and hand mobility Description:
Change in arm mobility the next day and 30 days after the end of the intervention. Arm and hand mobility will be assessed by the ARAT test. The maximum score on the ARAT is 57 points ( 0 to 57). A higher score indicates better arm function.
Measured: 1 day and 30 days after the end of the intervention
Secondary outcomes (2)
Hospital anxiety and depression
Change in anxiety and depression symptoms the next day and 30 days after the end of the intervention. The anxiety and depression symptoms will be assessed by means of the HADS scale score. Each subscale score ranges from 0 to 21, and higher scores indicate more severe anxiety and/or depressive symptoms.
Measured: 1 day and 30 days after the end of the intervention
Medical device safety
Adverse events associated with the stimulation, device and health attention are associated. It would be a measure of the number of events related or not related to the device. Each adverse event should be asses by ethical committee and medical team.
Measured: During the intervention period.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2025
- Study start1 Apr 2025 (estimated)
- Primary completion24 Nov 2025 (estimated)
- Study completion24 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Motor ImpairmentStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundación Cardiovascular de Colombia
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Science, Technology, and Innovation, Minciencias
- Responsible party
- Sponsor
- Investigators
- Sandra M Sanabria, Bacteriologist, PhD, Study director, Fundación Cardiovascular de Colombia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06895005
- Sponsor's protocol ID
- CEI-2021-03209
- Acronym
- INPULSE
- Status last verified
- Mar 2025
- First submitted
- 19 Mar 2025
- Last updated
- 30 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- 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 33894832Yuan H, Silberstein SD. Vagus Nerve and Vagus Nerve Stimulation, a Comprehensive Review: Part II. Headache. 2016 Feb;56(2):259-66. doi: 10.1111/head.12650. Epub 2015 Sep 18.
PubMed 26381725Yap JYY, Keatch C, Lambert E, Woods W, Stoddart PR, Kameneva T. Critical Review of Transcutaneous Vagus Nerve Stimulation: Challenges for Translation to Clinical Practice. Front Neurosci. 2020 Apr 28;14:284. doi: 10.3389/fnins.2020.00284. eCollection 2020.
PubMed 32410932van der Meij A, Wermer MJH. Vagus nerve stimulation: a potential new treatment for ischaemic stroke. Lancet. 2021 Apr 24;397(10284):1520-1521. doi: 10.1016/S0140-6736(21)00667-X. No abstract available.
PubMed 33894818Kong KH, Chua KS, Lee J. Recovery of upper limb dexterity in patients more than 1 year after stroke: Frequency, clinical correlates and predictors. NeuroRehabilitation. 2011;28(2):105-11. doi: 10.3233/NRE-2011-0639.
PubMed 21447911Dancause N, Nudo RJ. Shaping plasticity to enhance recovery after injury. Prog Brain Res. 2011;192:273-95. doi: 10.1016/B978-0-444-53355-5.00015-4.
PubMed 21763529Cramer SC. Repairing the human brain after stroke: I. Mechanisms of spontaneous recovery. Ann Neurol. 2008 Mar;63(3):272-87. doi: 10.1002/ana.21393.
PubMed 18383072Nakayama H, Jorgensen HS, Raaschou HO, Olsen TS. Recovery of upper extremity function in stroke patients: the Copenhagen Stroke Study. Arch Phys Med Rehabil. 1994 Apr;75(4):394-8. doi: 10.1016/0003-9993(94)90161-9.
PubMed 8172497Sacco RL, Kasner SE, Broderick JP, Caplan LR, Connors JJ, Culebras A, Elkind MS, George MG, Hamdan AD, Higashida RT, Hoh BL, Janis LS, Kase CS, Kleindorfer DO, Lee JM, Moseley ME, Peterson ED, Turan TN, Valderrama AL, Vinters HV; American Heart Association Stroke Council, Council on Cardiovascular Surgery and Anesthesia; Council on Cardiovascular Radiology and Intervention; Council on Cardiovascular and Stroke Nursing; Council on Epidemiology and Prevention; Council on Peripheral Vascular Disease; Council on Nutrition, Physical Activity and Metabolism. An updated definition of stroke for the 21st century: a statement for healthcare professionals from the American Heart Association/American Stroke Association. Stroke. 2013 Jul;44(7):2064-89. doi: 10.1161/STR.0b013e318296aeca. Epub 2013 May 7.
PubMed 23652265
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Transcutaneous Auricular Vagus Nerve Stimulation on Upper Limb Motor Recovery After Stroke
- ClinicalTrials.gov ID
- NCT06895005
- Acronym / sponsor ID
- INPULSE / CEI-2021-03209
- Conditions
- Motor Impairment, Motor Impairments, Stroke, Stroke; Sequelae, Stroke, Ischemic
- Keywords
- Stroke, Vagus nerve, Vagus nerve stimulation, Transcutaneous vagus nerve stimulation, Rehabilitation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Fundación Cardiovascular de ColombiaUniversity, hospital or other
- Collaborators
- Ministry of Science, Technology, and Innovation, Minciencias
- Study start
- 1 Apr 2025 (estimated)
- Primary completion
- 24 Nov 2025 (estimated)
- Study completion
- 24 Dec 2025 (estimated)
- First posted
- 26 Mar 2025 (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.
This study will evaluate the effects of transcutaneous vagus nerve stimulation in combination with physical rehabilitation on upper limb motor function of patients with stroke.
Detailed description
Stroke is a neurological condition caused by vascular problems such as cerebral infarction and/or intracerebral or subarachnoid hemorrhage(1). In 2019, more than 12 million strokes occurred worldwide, making it one of the leading causes of morbidity.
Motor impairment is considered one of the main problems resulting from this condition(2). Recovery of motor function occurs spontaneously during the first months after stroke(3) as a result of brain plasticity processes in the sensory and motor systems(4). It is estimated that 50 to 75% of patients with stroke persist with significant motor sequelae limiting daily activities(5).
Recently, Vagus Nerve Stimulation (VNS) has been proposed as an intervention that could have beneficial effects in the recovery of motor function in these patients, since it contributes to the generation of adaptive neuroplasticity and the activation of neuromodulators that reduce brain inflammation(6).
VNS has mainly been administered by using implanted electrodes, but more recently, a non-invasive technique, known as transcutaneous VNS (cervical or auricular) has been proposed. VNS has traditionally required the implantation of an electrical pulse generator at the left subclavicular level, which is connected to electrodes in the left cervical branch of the vagus nerve(7). Its insertion is performed by a surgical procedure, which presents a higher risk of adverse events(8), the most frequent being dysphonia during stimulation, due to its proximity to the laryngeal nerve(9). On the other hand, transcutaneous VNS works through the placement of non-invasive electrodes on the neck or auricle for stimulation of the cervical or auricular branch of the vagus nerve respectively(7). Transcutaneous VNS has a lower risk of adverse events, is reversible and easy to implement(7). In addition, experimental evidence suggests that the effects of transcutaneous VNS on brain function are comparable to those obtained with VNS(8).
This study will evaluate the effects of transcutaneous vagus nerve stimulation (tVNS) in combination with physical rehabilitation on upper limb motor function of patients with stroke. Thirty patients with ischemic stroke will be included in the study. Subjects will be randomized to tVNS + physical rehabilitation or sham stimulation + physical rehabilitation. Therapy sessions will be performed 3 times a week for six consecutive weeks. Efficacy will be evaluated by assessing the change in motor function of the upper limb, the next day and 30 days after the end of the intervention. The motor function of the upper limb will be assessed by means of the Fugl-Meyer scale score.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Transcutaneous auricular vagus nerve stimulation + rehabilitation therapy | Experimental | Device: Transcutaneous auricular vagus nerve stimulation + rehabilitation therapy |
| Sham stimulation + rehabilitation therapy | Sham comparator | Other: sham stimulation + rehabilitation therapy |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age >18 years and <75 years
- Unilateral supratentorial ischemic stroke that occurred at least 7 days but not more 30 days before enrollment.
- Modified Rankin Scale between 0 and 1 before stroke
- Contralesional UL motor impairment defined by NIHSS item 5 score ≥ 1 to ≤ 3.
- Ability to provide written informed consent.
Key exclusion criteria (13 listed)
- Significant cognitive or language impairment that would interfere with study participation or informed consent. This criterion will be defined by NIHSS item 1a-c score > 2, item 9 score > 1, item 11 score = 2.
- Medical conditions that could interfere with study participation, for example ear infections or skin wounds.
- Bradycardia (< 50 bpm) or hypotension (< 90/60 mmHg)
- Significant pre-existing disability
- History of stroke
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 |
|---|---|---|
| Transcutaneous auricular vagus nerve stimulation + rehabilitation therapyTranscutaneous auricular vagus nerve stimulation using INPULSE 3 times a week for six consecutive weeks. The stimulation parameters will be a frequency of 30Hz with a pulse width of 300 us and a stimulation time of 1.5 seconds for each respiratory cycle. The electrical current will be gradually increased to a maximum of 5 mA (0.25-mA increments) to allow adaptation to the stimulation until a comfortable tolerance level is achieved. Patients will receive physical rehabilitation therapy during stimulation, which will include reaching and grasping exercises, gross movements, turning objects, simulating specific tasks, inserting objects, opening and closing containers. | Device | Transcutaneous auricular vagus nerve stimulation + rehabilitation therapy |
| sham stimulation + rehabilitation therapyPatients will receive physical rehabilitation therapy during placebo stimulation (No electrical stimulation), including reaching and grasping exercises, gross movements, turning objects, simulating specific tasks, inserting objects, opening and closing containers. | Other | Sham stimulation + rehabilitation therapy |
Primary outcome
Motor function of the upper limb
Time frame: 1 day and 30 days after the end of the intervention
Efficacy will be assessed by evaluating the change in motor function of the upper limb, the next day and 30 days after the end of the intervention. The motor function of the upper limb will be assessed by means of the Fugl-Meyer scale score. The motor function component ranges from 0 to 100, where higher scores indicate better motor recovery.
Arm and hand mobility Description:
Time frame: 1 day and 30 days after the end of the intervention
Change in arm mobility the next day and 30 days after the end of the intervention. Arm and hand mobility will be assessed by the ARAT test. The maximum score on the ARAT is 57 points ( 0 to 57). A higher score indicates better arm function.
2 secondary outcomes
Hospital anxiety and depression
Time frame: 1 day and 30 days after the end of the intervention
Medical device safety
Time frame: During the intervention period.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2025.
- 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 26381725Yuan H, Silberstein SD. Vagus Nerve and Vagus Nerve Stimulation, a Comprehensive Review: Part II. Headache. 2016 Feb;56(2):259-66. doi: 10.1111/head.12650. Epub 2015 Sep 18.
- Background: PubMed 32410932Yap JYY, Keatch C, Lambert E, Woods W, Stoddart PR, Kameneva T. Critical Review of Transcutaneous Vagus Nerve Stimulation: Challenges for Translation to Clinical Practice. Front Neurosci. 2020 Apr 28;14:284. doi: 10.3389/fnins.2020.00284. eCollection 2020.
- Background: PubMed 33894818van der Meij A, Wermer MJH. Vagus nerve stimulation: a potential new treatment for ischaemic stroke. Lancet. 2021 Apr 24;397(10284):1520-1521. doi: 10.1016/S0140-6736(21)00667-X. No abstract available.
- Background: PubMed 21447911Kong KH, Chua KS, Lee J. Recovery of upper limb dexterity in patients more than 1 year after stroke: Frequency, clinical correlates and predictors. NeuroRehabilitation. 2011;28(2):105-11. doi: 10.3233/NRE-2011-0639.
- Background: PubMed 21763529Dancause N, Nudo RJ. Shaping plasticity to enhance recovery after injury. Prog Brain Res. 2011;192:273-95. doi: 10.1016/B978-0-444-53355-5.00015-4.
- Background: PubMed 18383072Cramer SC. Repairing the human brain after stroke: I. Mechanisms of spontaneous recovery. Ann Neurol. 2008 Mar;63(3):272-87. doi: 10.1002/ana.21393.
- Background: PubMed 8172497Nakayama H, Jorgensen HS, Raaschou HO, Olsen TS. Recovery of upper extremity function in stroke patients: the Copenhagen Stroke Study. Arch Phys Med Rehabil. 1994 Apr;75(4):394-8. doi: 10.1016/0003-9993(94)90161-9.
- Background: PubMed 23652265Sacco RL, Kasner SE, Broderick JP, Caplan LR, Connors JJ, Culebras A, Elkind MS, George MG, Hamdan AD, Higashida RT, Hoh BL, Janis LS, Kase CS, Kleindorfer DO, Lee JM, Moseley ME, Peterson ED, Turan TN, Valderrama AL, Vinters HV; American Heart Association Stroke Council, Council on Cardiovascular Surgery and Anesthesia; Council on Cardiovascular Radiology and Intervention; Council on Cardiovascular and Stroke Nursing; Council on Epidemiology and Prevention; Council on Peripheral Vascular Disease; Council on Nutrition, Physical Activity and Metabolism. An updated definition of stroke for the 21st century: a statement for healthcare professionals from the American Heart Association/American Stroke Association. Stroke. 2013 Jul;44(7):2064-89. doi: 10.1161/STR.0b013e318296aeca. Epub 2013 May 7.
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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.
Sandra M Sanabria, Bacteriologist, PhD contact
Sandra M Sanabria, Bacteriologist, PhD study director
Fundación Cardiovascular de Colombia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcutaneous auricular vagus nerve stimulation + rehabilitation therapy in people with Motor Impairment and Motor Impairments, run by Fundación Cardiovascular de Colombia at 1 site in Colombia.
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 7 inclusion and 13 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: opening soon, as of the sponsor's last update on 30 Mar 2025. 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 Colombia. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nicolas Peña Novoa, Physiotherapist ((+57) 3008682154, nicolasnovoa2000@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Motor function of the upper limb (time frame: 1 day and 30 days after the end of the intervention). The study lists 2 primary outcomes in all. 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 NCT06895005, which also lists 9 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 30 Mar 2025.