Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06540417
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-24
Brief Title:
Study of the Effects of the Non-invasive Trigeminal Nerve Stimulation on Ischemic Stroke Patients
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Study of the Neuroprotection and Rehabilitation Promotion of the Non-invasive Trigeminal Nerve Stimulation on Ischemic Stroke Patients
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
In patients with ischemic stroke the primary focus revolves around enhancing the neuroprotective and rehabilitative effects of external trigeminal nerve stimulation eTNS and elucidating its underlying central mechanisms Through clinical trials and neuroimaging studies this research endeavors to 1 investigate the clinical impact of TNS on brain protection and 2 rehabilitation acceleration in ischemic stroke patients while concurrently exploring the potential central nervous mechanisms involved The ultimate aim is to contribute a novel therapeutic approach to the clinical management of acute ischemic stroke
Detailed Description:
This study conducted a randomized controlled clinical trial with an intention to enroll 60 patients Patients were randomly assigned in a 11 ratio to two groups 1 External trigeminal nerve stimulation eTNS group intervention group 2 Standard treatment group control group eTNS was administered once daily for 30 consecutive days during the treatment period The eTNS stimulation protocol entailed targeting the bilateral supraorbital region as the non-invasive stimulation site with treatment administered for 30 days once daily during nighttime sleep for a minimum of 8 hours per day stimulation parameters set at 120 Hz 250 μs 30s ON-30s OFF with intensity adjusted to individual comfort levels For the standard treatment group a series of interventions excluding eTNS as directed by the treating physician were administered including but not limited to medications and rehabilitation therapies Blood samples and medical history information were collected at baseline Imaging data were acquired from participants at baseline and 5 days post-treatment Modified Rankin Scale mRS National Institutes of Health Stroke Scale NIHSS and Barthel Index BI were assessed at baseline 5 days post-treatment at the end of treatment and at 1- and 2-month follow-ups Additionally the 9-item Patient Health Questionnaire PHQ-9 Generalized Anxiety Disorder 7-item scale GAD-7 and Insomnia Severity Index ISI were administered at baseline the end of treatment and at 1- and 2-month follow-ups to evaluate participants emotional well-being and sleep patterns The recruited sample size met statistical requirements
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None