Combining Closed-loop Transcutaneous Auricular Vagus Nerve Stimulation and Focal Transcranial Direct Current Stimulation as an Adjuvant Treatment for Acute and Subacute Strokes

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Taiwan
National Cheng Kung University Hospital
RECRUITING
Tainan City
Contact Information
Primary
Pi-Shan Sung, MD,PhD
pishansung@gmail.com
+886-62353535
Backup
Chou-Ching Lin, MD,PhD
cxl45@mail.ncku.edu.tw
+886-62353535
Time Frame
Start Date: 2024-02-15
Estimated Completion Date: 2027-04-30
Participants
Target number of participants: 80
Treatments
Experimental: tDCS + taVNS
tDCS + taVNS will be applied before rehabilitation.
Active_comparator: tDCS + sham-taVNS
tDCS + sham-taVNS will be applied before rehabilitation.
Active_comparator: sham-tDCS + taVNS
sham-tDCS + taVNS will be applied before rehabilitation.
Sham_comparator: sham-tDCS + sham-taVNS
sham-tDCS + sham-taVNS will be applied before rehabilitation.
Related Therapeutic Areas
Sponsors
Leads: National Cheng-Kung University Hospital

This content was sourced from clinicaltrials.gov