Ischemic StrokeNCT06244914
Combined taVNS and tDCS in Subacute Stroke Patients
A study testing tDCS stimulation and taVNS stimulation in people with Ischemic Stroke, run by National Cheng-Kung University Hospital at 1 site in Taiwan.
Trial summary
Ischemic stroke, the most prevalent neurological disorder, is treated with medication and thrombectomy but with limited success, especially in chronic stages where traditional rehabilitation is the primary option. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ischemic Stroke
- What is being tested?
- tDCS stimulation and taVNS stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteTaiwan
- Study dates
- 15 Feb 2024to 30 Apr 2027
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years old
- Subacute ischemic stroke patients within 7-30 days after stroke symptoms is stabilized
- Stroke will be documented by DWI-MRI
- Lesion locations at least involve supratentorial area
- Patients have unilateral weakness documented with manual muscle testing scales less than 4
- Stable vital signs and stable neurological signs
- Able to receive regular rehabilitation programs, and 8) modified Rankin Scales (mRS) less than 5.
Who cannot join
- A National Institute of Health Stroke Scale (NIHSS) score > 25 at study entry
- The presence of hemineglect
- Moderate-to-severe pain in any limb
- Unstable clinical condition
- Recurrent strokes or brainstem strokes
- Marked arrhythmia or cardiovascular complications
Show all 18Show fewer
- Bradycardia (HR≤50 bpm) or low blood pressure (SBP≤100 mmHg or DBP≤60mmHg) at admission
- Patients with radiographic evidence or suspicion of chronic conditions that may predispose them to intracranial hemorrhage including brain arteriovenous malformations, cerebral cavernous malformations, cerebral telangiectasia, multiple previous intracerebral hemorrhages (amyloid angiopathy)
- Pre-existing coagulopathy, consist of platelet count of ≤100, INR≥ 3, PTT≥ 90
- Patients suspected of having infective endocarditis and ischemic stroke related to septic emboli
- Signs or symptoms of acute myocardial infarction, including EKG findings
- Concomitant experimental therapy
- Suspected cerebral vasculitis based on medical history and CTA/Magnetic Resonance Angiogram (MRA)
- Suspected cranial dural arteriovenous fistula, and evidence of dissection in the intracranial cerebral arteries
- Cerebral venous thrombosis and significant mass effect with midline shift
- History of left atrial myxoma
- Presence of contraindication for VNS (TENS) and tDCS: (A) Intracranial space occupied lesion, (B) Presence of a pacemaker, (C) History of brain neurosurgery, (D) Active CNS or systemic infection, (E) Presence of a metallic foreign body implant, (F) Skin abnormalities, (G) History of alcohol/drug abuse, (H) Epilepsy/History of epilepsy at family (I) Hyperacusis, (J) Cognitive/Consciousness disturbance, (K) Pregnancy or nursing females, (L) Use of neuropsycoactive drugs, (M) Psychiatric/ Neurologic disease
- Not suitable for equipping ECG recorders: (A) Chronic disease, and allergic to polyester, (B) Acute and severe patients
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
National Cheng Kung University Hospital
Tainan, Tainan, 71144
Chou-Ching Lin, MD, phD, +886-62353535 ext. 2692, cxl45@mail.ncku.edu.tw
About this study
Official title: Combining Closed-loop Transcutaneous Auricular Vagus Nerve Stimulation and Focal Transcranial Direct Current Stimulation as an Adjuvant Treatment for Acute and Subacute Strokes
Ischemic stroke, the most prevalent neurological disorder, is treated with medication and thrombectomy but with limited success, especially in chronic stages where traditional rehabilitation is the primary option. Stroke often leads to post-stroke autonomic imbalance, deteriorating functional outcomes and increasing recurrence risk. Emerging non-pharmacological treatments like Transcutaneous Auricular Vagus Nerve Stimulation (VNS) and Focused Transcranial Direct Current Stimulation (tDCS) offer new possibilities. VNS targets post-stroke tissue injury and promotes healing and neurogenesis, while tDCS aims to enhance motor learning by rebalancing brain activity. Both therapies seek to improve outcomes in both acute and chronic stroke stages.
Read the detailed description
Ischemic stroke is the most common neurological disease. The main treatment options include medication and endovascular thrombectomy. The benefits of treatments at acute stage are significant but far from satisfactory. There is no effective treatment for improvement at chronic stage, except traditional rehabilitation. In addition, stroke may induce post-stroke autonomic imbalance, further leading to worse post-stroke functional outcomes and the risk of recurrent stroke.
Except for pharmacological therapy against the risk of stroke, non-pharmacological neuromodulation may be proposed as another therapeutic options. Transcutaneous auricular vagus nerve stimulation (VNS) and focused transcranial direct current stimulation (tDCS) may be two of the options. The function of VNS is to modulate post-stroke tissue injury and promote angiogenesis/neurogenesis through non-pharmacological pathway. VNS may increase the parasympathetic activity for balancing the hyper-sympathetic state in the acute stage and enhancing neural plasticity in the chronic stage. On the other hand, the purpose of tDCS is to make substantial motor learning improvements, which may be through the re-balance both excitatory and inhibitory activation between hemispheres after stroke.
- Conditions
- Ischemic Stroke
- Being tested
- tDCS stimulation, taVNS stimulation, sham tDCS stimulation, sham taVNS stimulation
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tDCS stimulationDevice
tDCS 1mA will be applied for 20min. tDCS will be applied around the infract area. taVNS or sham taVNS wil be applied before tDCS. The intervention will be applied before physical therapy. A total of 10 sections are applied during the intervention period of 2 weeks.
taVNS stimulationDevice
taVNS will be applied for 30 min. The electrode will be placed on the left ear of the patient. The amplitude of taVNS will be adjusted under the patient's pain threshold. After taVNS, tDCS will be applied for 20 min. The intervention will be applied before physical therapy. A total of 10 sections are applied during the intervention period of 2 weeks.
sham tDCS stimulationDevice
sham tDCS 1mA will be applied for 20min. sham tDCS will be applied around the infract area. The stimulation will be applied for only 10 seconds and no stimulation afterward. taVNS or sham taVNS wil be applied before sham tDCS.The intervention will be applied before physical therapy. A total of 10 sections are applied during the intervention period of 2 weeks.
sham taVNS stimulationDevice
sham taVNS will be applied for 30 min. The electrode will be placed on the left ear of the patient. The amplitude of sham taVNS will be adjusted under the patient's pain threshold. The stimulation was only applied for 5 seconds and no stimulation afterward. After sham taVNS, tDCS or sham tDCS will be applied for 20 min. The intervention will be applied before physical therapy. A total of 10 sections are applied during the intervention period of 2 weeks.
| Study group | Role | What they receive |
|---|---|---|
| tDCS + taVNS | Experimental | tDCS + taVNS will be applied before rehabilitation. Receives: Device: tDCS stimulation; Device: taVNS stimulation |
| tDCS + sham-taVNS | Active comparator | tDCS + sham-taVNS will be applied before rehabilitation. Receives: Device: tDCS stimulation; Device: sham taVNS stimulation |
| sham-tDCS + taVNS | Active comparator | sham-tDCS + taVNS will be applied before rehabilitation. Receives: Device: taVNS stimulation; Device: sham tDCS stimulation |
| sham-tDCS + sham-taVNS | Sham comparator | sham-tDCS + sham-taVNS will be applied before rehabilitation. Receives: Device: sham tDCS stimulation; Device: sham taVNS stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disability Severity Assessment Using the Modified Rankin Scale (mRS)
- Description: The Modified Rankin Scale (mRS) is a widely used 6-point disability scale evaluating the degree of disability or dependence in daily activities of people who have suffered a stroke.
- Scale Range: 0 (no symptoms) to 5 (severe disability).
- Score Interpretation: Higher scores indicate a worse outcome, reflecting increased disability.
Measured: 0, 4, 12 week
Motor Function Assessment Using Fugl-Meyer Assessment (FMA) for Upper Extremity (UE) and Lower Extremity (LE)
- Description: The Fugl-Meyer Assessment (FMA) is a stroke-specific, performance-based impairment index designed to assess motor functioning, balance, sensation, and joint functioning in patients with post-stroke hemiplegia. It evaluates the motor recovery post-stroke, focusing on voluntary movements and joint functions.
- Scale Range:
Upper Extremity (UE): 0 to 66 Lower Extremity (LE): 0 to 34
- Score Interpretation: Higher scores indicate better motor functioning, reflecting greater voluntary movement capability and reduced impairment.
Measured: 0, 4, 12 week
Upper Limb Motor Function Evaluation Using the Wolf Motor Function Test (WMFT)
- Description: The WMFT is designed to assess motor ability through timed and functional tasks in individuals with upper extremity motor impairment.
- Scale Range:
Timed Tasks: Seconds to complete, up to 120 seconds per task. Functional Tasks: Scored 0 to 5 on functional ability.
- Score Interpretation:
Timed Tasks: Lower completion times indicate better motor function. Functional Tasks: Higher scores represent greater functional ability and more normal movement patterns.
Measured: 0, 4, 12 week
Mobility and Balance Assessment Using the Time Up and Go Test (TUG)
- Description: The TUG test measures the time taken by an individual to stand up from a seated position, walk a short distance, turn around, walk back, and sit down.
- Scale Range: Time in seconds.
- Score Interpretation: Lower times indicate better mobility and balance.
Measured: 0, 4, 12 week
Secondary outcomes (4)
Autonomic Function Assessment through Heart Rate Variability (HRV) Analysis
- Description: HRV is used to evaluate autonomic nervous system function by analyzing the variation in time intervals between heartbeats.
- Scale Range:
SDNN: Measured in milliseconds, with a wide variability range. RMSSD: Also measured in milliseconds, with higher values indicating increased parasympathetic activity.
- Score Interpretation: Higher HRV values signify greater heart rate variability, typically reflecting better autonomic function and cardiovascular health.
Measured: 0, 4, 12 week
Cognitive Function Assessment Using Montreal Cognitive Assessment (MoCA)
- Description: The MoCA is utilized to assess various cognitive abilities, including memory, language, attention, and spatial and temporal orientation, offering a comprehensive overview of an individual's cognitive status.
- Scale Range: The total score ranges from 0 to 30, with higher scores indicating better cognitive performance.
- Score Interpretation: Scores near 30 suggest normal cognitive functioning, while scores below 26 may indicate cognitive impairments, warranting further clinical evaluation.
Measured: 0, 4, 12 week
Depression Severity Measurement Using Montgomery-Asberg Depression Rating Scale (MADRS)
- Description: The MADRS is a clinician-administered scale assessing the depth and severity of depressive symptoms, focusing on both psychological and physical aspects of depression. It is valuable in tracking symptom changes and treatment efficacy.
- Scale Range: The total score ranges from 0 to 60, derived from ten items each scored from 0 to 6.
- Score Interpretation: Scores nearer to 60 reflect more severe depression, while lower scores indicate milder depressive symptoms.
Measured: 0, 4, 12 week
Quality of Life Evaluation Using the EQ-5D-5L
- Description: The EQ-5D-5L is a comprehensive tool assessing health-related quality of life across five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression, each rated on a five-point severity scale.
- Scale Range:
Descriptive Profile: 1 (no problems) to 5 (extreme problems) for each dimension.
EQ VAS: 0 (worst imaginable health state) to 100 (best imaginable health state).
- Score Interpretation:
Descriptive Profile: Lower scores indicate better health status in each dimension.
EQ VAS: Higher scores reflect better overall health and quality of life.
Measured: 0, 4, 12 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2024
- Study start15 Feb 2024
- Primary completion30 Apr 2025 (estimated)
- Study completion30 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemic StrokeStudies of the same condition, open and under way.
- More trials run by National Cheng-Kung University HospitalThe sponsor's other registered studies.
- 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Cheng-Kung University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06244914
- Sponsor's protocol ID
- A-BR-112-009
- Status last verified
- Jan 2024
- First submitted
- 4 Jan 2024
- Last updated
- 20 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combining Closed-loop Transcutaneous Auricular Vagus Nerve Stimulation and Focal Transcranial Direct Current Stimulation as an Adjuvant Treatment for Acute and Subacute Strokes
- ClinicalTrials.gov ID
- NCT06244914
- Acronym / sponsor ID
- A-BR-112-009
- Conditions
- Ischemic Stroke
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- National Cheng-Kung University HospitalUniversity, hospital or other
- Study start
- 15 Feb 2024 (actual)
- Primary completion
- 30 Apr 2025 (estimated)
- Study completion
- 30 Apr 2027 (estimated)
- First posted
- 6 Feb 2024 (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.
Ischemic stroke, the most prevalent neurological disorder, is treated with medication and thrombectomy but with limited success, especially in chronic stages where traditional rehabilitation is the primary option. Stroke often leads to post-stroke autonomic imbalance, deteriorating functional outcomes and increasing recurrence risk. Emerging non-pharmacological treatments like Transcutaneous Auricular Vagus Nerve Stimulation (VNS) and Focused Transcranial Direct Current Stimulation (tDCS) offer new possibilities. VNS targets post-stroke tissue injury and promotes healing and neurogenesis, while tDCS aims to enhance motor learning by rebalancing brain activity. Both therapies seek to improve outcomes in both acute and chronic stroke stages.
Detailed description
Ischemic stroke is the most common neurological disease. The main treatment options include medication and endovascular thrombectomy. The benefits of treatments at acute stage are significant but far from satisfactory. There is no effective treatment for improvement at chronic stage, except traditional rehabilitation. In addition, stroke may induce post-stroke autonomic imbalance, further leading to worse post-stroke functional outcomes and the risk of recurrent stroke.
Except for pharmacological therapy against the risk of stroke, non-pharmacological neuromodulation may be proposed as another therapeutic options. Transcutaneous auricular vagus nerve stimulation (VNS) and focused transcranial direct current stimulation (tDCS) may be two of the options. The function of VNS is to modulate post-stroke tissue injury and promote angiogenesis/neurogenesis through non-pharmacological pathway. VNS may increase the parasympathetic activity for balancing the hyper-sympathetic state in the acute stage and enhancing neural plasticity in the chronic stage. On the other hand, the purpose of tDCS is to make substantial motor learning improvements, which may be through the re-balance both excitatory and inhibitory activation between hemispheres after stroke.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| tDCS + taVNS | Experimental | Device: tDCS stimulation, Device: taVNS stimulationtDCS + taVNS will be applied before rehabilitation. |
| tDCS + sham-taVNS | Active comparator | Device: tDCS stimulation, Device: sham taVNS stimulationtDCS + sham-taVNS will be applied before rehabilitation. |
| sham-tDCS + taVNS | Active comparator | Device: taVNS stimulation, Device: sham tDCS stimulationsham-tDCS + taVNS will be applied before rehabilitation. |
| sham-tDCS + sham-taVNS | Sham comparator | Device: sham tDCS stimulation, Device: sham taVNS stimulationsham-tDCS + sham-taVNS will be applied before rehabilitation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age ≥ 18 years old
- Subacute ischemic stroke patients within 7-30 days after stroke symptoms is stabilized
- Stroke will be documented by DWI-MRI
- Lesion locations at least involve supratentorial area
- Patients have unilateral weakness documented with manual muscle testing scales less than 4
Key exclusion criteria (18 listed)
- A National Institute of Health Stroke Scale (NIHSS) score > 25 at study entry
- The presence of hemineglect
- Moderate-to-severe pain in any limb
- Unstable clinical condition
- Recurrent strokes or brainstem strokes
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 |
|---|---|---|
| tDCS stimulationtDCS 1mA will be applied for 20min. tDCS will be applied around the infract area. taVNS or sham taVNS wil be applied before tDCS. The intervention will be applied before physical therapy. A total of 10 sections are applied during the intervention period of 2 weeks. | Device | tDCS + sham-taVNS, tDCS + taVNS |
| taVNS stimulationtaVNS will be applied for 30 min. The electrode will be placed on the left ear of the patient. The amplitude of taVNS will be adjusted under the patient's pain threshold. After taVNS, tDCS will be applied for 20 min. The intervention will be applied before physical therapy. A total of 10 sections are applied during the intervention period of 2 weeks. | Device | sham-tDCS + taVNS, tDCS + taVNS |
| sham tDCS stimulationsham tDCS 1mA will be applied for 20min. sham tDCS will be applied around the infract area. The stimulation will be applied for only 10 seconds and no stimulation afterward. taVNS or sham taVNS wil be applied before sham tDCS.The intervention will be applied before physical therapy. A total of 10 sections are applied during the intervention period of 2 weeks. | Device | sham-tDCS + sham-taVNS, sham-tDCS + taVNS |
| sham taVNS stimulationsham taVNS will be applied for 30 min. The electrode will be placed on the left ear of the patient. The amplitude of sham taVNS will be adjusted under the patient's pain threshold. The stimulation was only applied for 5 seconds and no stimulation afterward. After sham taVNS, tDCS or sham tDCS will be applied for 20 min. The intervention will be applied before physical therapy. A total of 10 sections are applied during the intervention period of 2 weeks. | Device | sham-tDCS + sham-taVNS, tDCS + sham-taVNS |
Primary outcome
Disability Severity Assessment Using the Modified Rankin Scale (mRS)
Time frame: 0, 4, 12 week
* Description: The Modified Rankin Scale (mRS) is a widely used 6-point disability scale evaluating the degree of disability or dependence in daily activities of people who have suffered a stroke. * Scale Range: 0 (no symptoms) to 5 (severe disability). * Score Interpretation: Higher scores indicate a worse outcome, reflecting increased disability.
Motor Function Assessment Using Fugl-Meyer Assessment (FMA) for Upper Extremity (UE) and Lower Extremity (LE)
Time frame: 0, 4, 12 week
* Description: The Fugl-Meyer Assessment (FMA) is a stroke-specific, performance-based impairment index designed to assess motor functioning, balance, sensation, and joint functioning in patients with post-stroke hemiplegia. It evaluates the motor recovery post-stroke, focusing on voluntary movements and joint functions. * Scale Range: Upper Extremity (UE): 0 to 66 Lower Extremity (LE): 0 to 34 * Score Interpretation: Higher scores indicate better motor functioning, reflecting greater voluntary movement capability and reduced impairment.
Upper Limb Motor Function Evaluation Using the Wolf Motor Function Test (WMFT)
Time frame: 0, 4, 12 week
* Description: The WMFT is designed to assess motor ability through timed and functional tasks in individuals with upper extremity motor impairment. * Scale Range: Timed Tasks: Seconds to complete, up to 120 seconds per task. Functional Tasks: Scored 0 to 5 on functional ability. * Score Interpretation: Timed Tasks: Lower completion times indicate better motor function. Functional Tasks: Higher scores represent greater functional ability and more normal movement patterns.
Mobility and Balance Assessment Using the Time Up and Go Test (TUG)
Time frame: 0, 4, 12 week
* Description: The TUG test measures the time taken by an individual to stand up from a seated position, walk a short distance, turn around, walk back, and sit down. * Scale Range: Time in seconds. * Score Interpretation: Lower times indicate better mobility and balance.
4 secondary outcomes
Autonomic Function Assessment through Heart Rate Variability (HRV) Analysis
Time frame: 0, 4, 12 week
Cognitive Function Assessment Using Montreal Cognitive Assessment (MoCA)
Time frame: 0, 4, 12 week
Depression Severity Measurement Using Montgomery-Asberg Depression Rating Scale (MADRS)
Time frame: 0, 4, 12 week
Quality of Life Evaluation Using the EQ-5D-5L
Time frame: 0, 4, 12 week
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 20 Mar 2024.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing tDCS stimulation and taVNS stimulation in people with Ischemic Stroke, run by National Cheng-Kung University Hospital at 1 site in Taiwan.
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 18 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: looking for participants now, as of the sponsor's last update on 20 Mar 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 Taiwan. 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 Pi-Shan Sung, MD,PhD (+886-62353535 ext. 3891, pishansung@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disability Severity Assessment Using the Modified Rankin Scale (mRS) (time frame: 0, 4, 12 week). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Mar 2024.