EEG Changes Related to Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) in Acute Stroke Patients: a Preliminary Study

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

In the United States, more than 795,000 people have a stroke every year. Motor impairment after a stroke is common and can be debilitating. To date, there remain few treatments available to help improve motor recovery after a stroke, making this an important area of research. Novel use of neuromodulation such as Invasive Vagus Nerve Stimulation (VNS) has been shown to improve motor recovery in stroke patients. Vagus nerve stimulation (VNS), in which the nerve is stimulated with electrical pulses, has demonstrated success for a variety of conditions, including inflammation, depression, cognitive dysfunction, chronic fatigue, headaches/migraines, pain, insomnia, and cardiovascular issues. Very recently, non-invasive options have been developed and might be a promising alternative. The research in this area is still very limited and much more research is needed to investigate non-invasive/trancutaneous auricular vagus nerve stimulation (taVNS) related biomechanisms and to further support its efficacy in acute patients. The purpose of this study is to build upon the current research to investigate changes in electrical brain activity (using electrophysiology) related to improvements in both motor and cognitive recovery following the use of taVNS in acute stroke patients.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:

• First-time Cerebrovascular Accident (Ischemic or Hemorrhagic)

• Within a month post-injury

Locations
United States
California
Casa Colina Hospital and Centers for Healthcare
RECRUITING
Pomona
Contact Information
Primary
Caroline Schnakers, PhD
cschnakers@casacolina.org
(909)596-7733
Backup
Niko Fullmer, BS
nfullmer@casacolina.org
(909)596-7733
Time Frame
Start Date: 2024-01-29
Estimated Completion Date: 2025-06-30
Participants
Target number of participants: 22
Treatments
Experimental: TaVNS intervention
Before starting applying taVNS, patients will be assessed using the FMA-U and the mRS for motor recovery as well as the MOCA for cognitive recovery. Resting state EEG will be recorded with eyes open during 15 minutes using our 64 electrodes cap (actiCHamp Plus; brainproducts.com), just after the behavioral assessment is performed. On the same day, patients will receive taVNS for 45 minutes, during therapy. The stimulation parameters, will be as follows: 250ms square pulses at 20 Hz. The electrical stimulation will given for 45 minutes a day for 10 working days (5 days a week for 2 weeks). The amplitude will be 1.7mA but may be reduced to 1.0mA if the patient is unable to tolerate due to discomfort or pain. After the last taVNS session is applied, outcome measures will be administered again by the research team. A follow-up at 6 months after the end of the last session will be conducted over the phone using the adapted version of the mRS and the MOCA.
Related Therapeutic Areas
Sponsors
Leads: Casa Colina Hospital and Centers for Healthcare
Collaborators: Foundation for Physical Medicine and Rehabilitation

This content was sourced from clinicaltrials.gov