Combined taVNS and tDCS in Subacute Stroke Patients

NCT06244914 | Recruiting

• 1 other identifier: A-BR-112-009
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Ischemic Stroke

Outcome Measures

Primary Outcomes (4)

• 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.

  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.

  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.

  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.

  0, 4, 12 week

Secondary Outcomes (4)

• Autonomic Function Assessment through Heart Rate Variability (HRV) Analysis

  0, 4, 12 week

• Cognitive Function Assessment Using Montreal Cognitive Assessment (MoCA)

  0, 4, 12 week

• Depression Severity Measurement Using Montgomery-Asberg Depression Rating Scale (MADRS)

  0, 4, 12 week

• Quality of Life Evaluation Using the EQ-5D-5L

  0, 4, 12 week

Study Arms (4)

tDCS + taVNS

EXPERIMENTAL

tDCS + taVNS will be applied before rehabilitation.

Device: tDCS stimulation; Device: taVNS stimulation

tDCS + sham-taVNS

ACTIVE COMPARATOR

tDCS + sham-taVNS will be applied before rehabilitation.

Device: tDCS stimulation; Device: sham taVNS stimulation

sham-tDCS + taVNS

ACTIVE COMPARATOR

sham-tDCS + taVNS will be applied before rehabilitation.

Device: taVNS stimulation; Device: sham tDCS stimulation

sham-tDCS + sham-taVNS

SHAM COMPARATOR

sham-tDCS + sham-taVNS will be applied before rehabilitation.

Device: sham tDCS stimulation; Device: sham taVNS stimulation

Interventions

tDCS stimulation DEVICE

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.

tDCS + sham-taVNS; tDCS + taVNS

taVNS stimulation DEVICE

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 + taVNS; tDCS + taVNS

sham tDCS stimulation DEVICE

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-tDCS + sham-taVNS; sham-tDCS + taVNS

sham taVNS stimulation DEVICE

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.

sham-tDCS + sham-taVNS; tDCS + sham-taVNS

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• National Cheng-Kung University Hospital: lead

Study Sites (1)

National Cheng Kung University Hospital

Tainan, Tainan, 71144, Taiwan

RECRUITING

MeSH Terms

Conditions

Ischemic Stroke

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Central Study Contacts

Pi-Shan Sung, MD,PhD

CONTACT

+886-62353535; pishansung@gmail.com

Chou-Ching Lin, MD,PhD

CONTACT

+886-62353535; cxl45@mail.ncku.edu.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 4, 2024
• First Posted: February 6, 2024
• Study Start: February 15, 2024
• Primary Completion: April 30, 2025
• Study Completion (Estimated): April 30, 2027
• Last Updated: March 20, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)