Stroke, Ischemic Clinical Trial
Official title:
Feasibility of Trigeminal and Vagus Nerve Stimulation in Subjects With Chronic Upper Extremity Deficits After Stroke
NCT number | NCT06288217 |
Other study ID # | NS-CIP-001 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | March 5, 2024 |
Est. completion date | December 2024 |
This is a single-center, pilot study of up to 25 subjects with residual upper extremity deficits at least six months after an ischemic stroke. The purpose of the study is to evaluate the initial clinical safety, device functionality, and treatment effect of non-invasive electrical stimulation of the trigeminal and/or vagus nerves (nTVNS) using the NeuraStasis Stimulator System adjunctive to rehabilitation. Subjects will either receive the intervention or control-sham stimulation. The study will inform the design and implementation of a pivotal study.
Status | Recruiting |
Enrollment | 25 |
Est. completion date | December 2024 |
Est. primary completion date | December 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 40 Years to 80 Years |
Eligibility | Inclusion Criteria: - History of unilateral supratentorial ischemic stroke that occurred at least 6 months but not more than 10 years prior to enrollment. - Age >40 years and <80 years. - Fugl-Meyer Assessment, Upper Limb (FMA-UE) baseline score of 20 to 50 (inclusive of 20 and 50). - Ability to communicate, understand, and provide appropriate consent. Subjects should be able to follow two-step commands. - Right- or left-sided weakness of the upper extremity. Exclusion Criteria - Participant has implanted metallic or electronic devices in the head or neck - Hemorrhagic stroke or a heterogenous lesion etiology - Participant has a cardiac pacemaker or implanted or wearable defibrillator - Participant skin in the stimulation area has open wounds, skin eruptions, swollen, infected, or inflamed areas, or skin abnormalities that could be cancerous - Advanced cardiac, pulmonary, liver, kidney dysfunction or blood system disease - Participant has a fever or shows clinical signs concerning for an infectious disease - Other neurologic or musculoskeletal diseases that could interfere with the assessments of this study - Low heart rate (<60 bpm) from a cardiac conduction block or related etiology - Participant has a history of trigeminal neuralgia - Participant has a history of Bell's Palsy - History of cranial nerve neuropathy (including facial nerve injury), carotid surgery, vagotomy, or other surgical intervention on the vagus nerve - History of recurrent syncopal events - Known or newly-discovered aneurysm or arteriovenous malformation - Patients who have any terminal illness such that the patient would not be expected to survive more than 90 days - Botox injections 12 weeks prior to or during therapy |
Country | Name | City | State |
---|---|---|---|
United States | The University of Texas Health Science Center at Houston | Houston | Texas |
Lead Sponsor | Collaborator |
---|---|
NeuraStasis, Inc |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Fugl-Meyer Assessment, Upper Limb (FMA-UE) Average Change | The Fugl-Meyer Assessment, Upper Limb (FMA-UE) will be analyzed for the difference in average change after 6 weeks of therapy compared to baseline. The FMA-UE is a common scale used to measure motor impairment after a stroke. The range is 0 (more impairment) to 66 (no impairment). | Within 7 days of completing 6 weeks of rehabilitation | |
Secondary | Action Research Arm Test (ARAT) Average Change | The ARAT will be analyzed for the difference in average change after 6 weeks of therapy compared to baseline. The ARAT is a widely used clinical scoring tool for stroke rehabilitation. The test consists of 19 items that are grouped into four sub-tests: grasp, grip, pinch, and gross movement. The total score on the ARAT ranges from 0 to 57, with a higher score indicating better performance. | Within 7 days of completing 6 weeks of rehabilitation | |
Secondary | Fugl-Meyer Assessment, Upper Limb (FMA-UE) Response % | The FMA-UE will be analyzed for the % of subjects that responded to treatment defined as achieving an effect equivalent to a greater than the minimal clinically important difference. | Within 7 days of completing 6 weeks of rehabilitation | |
Secondary | Proportion of subjects completing all pre-specified treatment doses | Proportion of subjects completing all pre-specified treatment sessions across the 6 weeks of rehabilitation | Upon completion of 6 weeks of rehabilitation | |
Secondary | Subject Questionnaire on Device Usage | A questionnaire that evaluates subjects' level of comfort during use of the device on a 5-point scale, with 5 being the most comfortable and 1 being the least comfortable. | Upon completion of 6 weeks of rehabilitation | |
Secondary | Therapist Questionnaire on Device Usage | A questionnaire that evaluates the ease of use of the device by therapists during the administration of rehab with the device on a 5-point scale, with 5 being the most usable and 1 being the least usable. | Upon completion of 6 weeks of rehabilitation | |
Secondary | Serious adverse device effects (SADE) rate at 24 hours post-therapy session | SADE rate at 24 hours post-therapy sessions | Up to 24 hours after each therapy session and ending 24 hours post-last therapy session at 6 weeks of rehabilitation | |
Secondary | Stroke impact scale (SIS) Summative Score Average Change | The Stroke Impact Scale (SIS) is a multidimensional self-reported measure of health-related quality of life. The SIS includes 59 items and assesses 8 domains: strength (four items), memory and thinking (seven items), emotion (nine items), communication (seven items), activities of daily living (ten items), mobility (nine items), hand function (five items) and participation and function in life activities (ten items). Each item is rated using a 5-point Likert-type scale (1 = an inability to complete the item; 5 = no difficulty experienced at all) and a global score is calculated as a summative score of each domain, transformed into a 0-100 scale. It includes an extra question on the personĀ“s perceived stroke recovery measured in the form of a visual analogue scale from 0-100. The summative score will be analyzed for the difference in average change after 6 weeks of therapy compared to baseline. | Within 7 days of completing 6 weeks of rehabilitation | |
Secondary | Analysis of the number of stimulations per therapy session | The number of paired stimulations initiated each rehabilitation session will be analyzed to understand personalized effectiveness and responder likelihood. | Upon completion of 6 weeks of rehabilitation |
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