Recruiting

Vagal Nerve Stimulation

Sponsor:

Casa Colina Hospital and Centers for Healthcare

Code:

NCT07858656

Conditions

Stroke

Ischemic Cerebrovascular Accident

Ischemic Stroke

Vagal Nerve Stimulation

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

transauricular Vagal Nerve Stimulation

Sham Comparator

Study Details

Brief summary:

The goal of this clinical trial is to learn if a device which provides vagal nerve stimulation, applied to the tragus of the ear via an ear clip, can improve sleep in individuals recovering from stroke while they are treated in a rehabilitation hospital. The main questions this study aims to answer are:

1. Does using this device improve insomnia?
2. Does this device have any impact on the person's stroke severity, mobility, self-care, or ability to think? Researchers will compare this treatment to a sham (a look-alike device that will not deliver the stimulation).

Participants will:

  • Complete questionnaires about insomnia and their ability to think
  • Use the device for 30 minutes every evening for at least 10 nights during their inpatient stay
  • Complete a log tracking their use of the device and any concerns

Conditions

Stroke

Ischemic Cerebrovascular Accident

Ischemic Stroke

Vagal Nerve Stimulation

Study ID

NCT07858656

Start date

Oct 16, 2026

Status verified date

Nov, 2026

Completion date

Dec 16, 2027

Anticipated

Primary completion date

Oct 16, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Admitted to Casa Colina's acute rehabilitation service
2. Diagnosis of ischemic stroke
3. Age 18 years or older
4. English or Spanish speaking
5. Sufficient cognition to follow program instructions tested Mini Mental Exam (score >17/30)
6. Confirmed sleep abnormalities based on the Insomnia Severity Index (ISI) meeting criteria for subthreshold or clinical insomnia (score >7/28)

Exclusion Criteria:

1. Hemorrhagic stroke or hemorrhagic conversion of ischemic stroke
2. Other confirmed neurological diagnoses
3. Previous surgical intervention on the vagus nerve
4. Any open wound or cancerous lesions at the ear within 1 inch of the ear tragus
5. Contraindication to the device, including patients with severe bradycardia, patients with a permanent implanted metallic or electronic device or jewelry at close proximity (2cm) to the ear tragus, patients with a recent (within 1 year) history of trigeminal neuralgia, pregnancy

Study Design

Enrollment

52 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: transauricular Vagal Nerve Stimulation (taVNS)

Participants will be assessed for cognition via the Mini Mental Exam and the Insomnia Severity Index (ISI). The initial assessments will be completed within the first 3-5 days from admission to the acute rehabilitation unit. Participants will receive a handout on sleep hygiene. Participants will be instructed around the use of the non-invasive taVNS Parasym device (by Parasym Ltd., London) and the training log which will include reporting of any side effects and any other personal bedtime routines to assist with sleep. The participant will be instructed to utilize the Parasym device for 30min daily between 7-9pm for at least 10 days following. Reassessment of the ISI will be completed at 12-15 days, or earlier if the patient discharges prior to this timeline. These participants will continue to receive the usual care for their individual rehabilitation program including therapy and medication interventions.

sham comparator: Sham transauricular Vagal Nerve Stimulation (Sham taVNS)

Participants will be assessed for cognition via the Mini Mental Exam and the Insomnia Severity Index (ISI). The initial assessments will be completed within the first 3-5 days from admission to the acute rehabilitation unit. Participants will receive a handout on sleep hygiene. Participants will be instructed around the use of the non-invasive taVNS Parasym device (by Parasym Ltd., London) and the training log which will include reporting of any side effects and any other personal bedtime routines to assist with sleep. The participant will be instructed to utilize the Parasym device for 30min daily between 7-9pm for at least 10 days following. For this group, their issued devices will include a sham earpiece that will prevent transmission of taVNS. The ISI will be re-assessed at 12-15 days, or earlier if the patient discharges prior to this timeline. Participants will continue to receive the usual care for their individual rehabilitation program, including therapy and medications.

Interventions

transauricular Vagal Nerve Stimulation

All participants will be instructed around the use of the non-invasive taVNS Parasym device (by Parasym Ltd., London). Participants will be instructed to utilize the Parasym device for 30min daily between 7-9pm for at least 10 days following. Stimulation parameters will be set at 200µs pulse width (with proprietary waveform) and 20Hz. The intensity will be set to level 21 and increased up to 32 as tolerated, but reduced sequentially to intensity level 12 if unable to tolerate due to discomfort. They will include amplitudes 1.0-1.7mA for therapeutic thresholds.

Sham Comparator

All participants will be instructed around the use of the non-invasive taVNS Parasym device (by Parasym Ltd., London). Participants will be instructed to utilize the Parasym device for 30min daily between 7-9pm for at least 10 days following. Stimulation parameters will be set to the same parameters as for the experimental group, however his device will include a sham earpiece that will prevent the transmission of taVNS.

Primary outcome measure

  • Insomnia Severity Index [ Time Frame: Initial assessment on Day 3-5 of their inpatient stay. Reassessment at 12-15 days, or earlier if the patient discharges prior to this timeline. ]

Central Contacts and Locations

Central contacts

Marie Yeseta, PT, DPT, NCS

9095967733myeseta@casacolina.org

Hannah Cone, PT, DPT, NCS

9095967733HCone@casacolina.org

Locations

Casa Colina Hospital and Centers for Healthcare

Recruiting

Pomona, California, United States, 91767

Contacts

Niko Fullmer

9095967733NFullmer@casacolina.org

Emily Rosario, PhD

9095967733ERosario@casacolina.org

Principal Investigator:

Marie Yeseta, PT, DPT, NCS

More Information

Sponsor

Casa Colina Hospital and Centers for Healthcare

Last update posted

Nov 4, 2026

Last verified

Nov, 2026

Keywords

  • Vagal Nerve Stimulation
  • Post Acute Care
  • Stroke
  • Cerebrovascular Accident

Trial information was received from ClinicalTrials.gov and was last updated on 2026-11-05. This information was provided to ClinicalTrials.gov by Casa Colina Hospital and Centers for Healthcare on 2026-11-04. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.