Paired Non-invasive VNS in Adolescent Cerebral Palsy Rehabilitation

Официальное название

Use of Paired Non-Invasive Vagus Nerve Stimulation in Rehabilitation of Adolescents With Cerebral Palsy: An Open Label Safety Feasibility Trial

Обзор

This is an open-label safety and feasibility trial evaluating the use of paired non-invasive vagus nerve stimulation (VNS) and upper extremity (UE) rehabilitation in the motor impairment reduction of adolescent patients with spastic cerebral palsy.

Вмешательства

• Устройство Non-invasive taVNS
  Device activates the vagus through the ear. The device is controlled via the Vagustim mobile app, which connects using Bluetooth Low Energy (BLE).

Первичные конечные точки

• Number of adverse event and serious adverse events [Срок оценки: 12 months]

Вторичные конечные точки (8)

• Number of therapy sessions complete [Срок оценки: end of therapy visits at Day 46]
• Active training time per session [Срок оценки: end of therapy visits at Day 46]
• Number of movement repetitions completed per session [Срок оценки: end of therapy visits at Day 46]
• Jebsen Taylor Hand Function Test (JTHFT) [Срок оценки: baseline Day 1, start of therapy Day 3, end of therapy Day 46, and 3, 6, 9, and 12 months]
• BOT-2 [Срок оценки: baseline Day 1, start of therapy Day 3, end of therapy Day 46, and 3, 6, 9, and 12 months]
• ABILHANDS [Срок оценки: baseline Day 1, start of therapy Day 3, end of therapy Day 46, and 3, 6, 9, and 12 months]
• Pediatric Evaluation of Disability (PEDI) [Срок оценки: at 12 months]
• Pediatric Quality of Life Inventory (PedsQL) [Срок оценки: baseline Day 1, start of therapy Day 3, end of therapy Day 46, and 3, 6, 9, and 12 months]

Критерии участия

Критерии включения

• Age 12-17 years old
• Diagnosis of spastic cerebral palsy
• Gross Motor Function Classification System (GMFCS) Level II-III (will be evaluated at screening)
• Jebsen Taylor Hand Function Test Score of <37.08 on the affected side at time of screening visit (will be evaluated at screening)
• Ability to communicate and follow two step commands at the time of screening
• Ability to provide assent as detailed in consent form and based on assessment using the University of California, San Diego Brief Assessment of Capacity to Consent

Критерии исключения

• Previous vagus nerve injury
• Less than 12 years old or greater than 18 years old
• History of left or bilateral vagotomy
• Current use of other implanted stimulation devices including but not limited to pacemaker, deep brain stimulator, implanted vagus nerve stimulators, cochlear implants, implantable cardiac defibrillators (ICDs)etc.
• Current use of any investigational devices or investigational drugs not otherwise specified - Past Medical History for any of the following:

• Acute suicidal thinking or behavior
• History of schizophrenia, schizoaffective disorder, or delusional disorders
• History of rapid cycling bipolar disorder
• Progressive neurological diseases
• Cardiac arrhythmias or other abnormalities
• History of dysautonomia including but not limited to orthostatic hypotension, postural orthostatic tachycardia syndrome, vasovagal syncope etc.
• GMFCS score of less than II or greater than III (will be evaluated at screening)
• Jebsen Taylor Hand Function Test Score of >37.08 on the affected side at time of screening visit (will be evaluated at screening)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Другое

Центры проведения

США · 1 центр

• The Charles Lazarus Children's Abilities Center — New York

Идентификаторы

NCT: NCT07394608 · STUDY-25-01164

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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