Transcutaneous Spinal Cord Stimulation Home Study

Официальное название

The Safety and Feasibility of Home-based Non-invasive Spinal Cord Stimulation for Orthostatic Hypotension in Individuals with Severe Autonomic Dysfunctions

Обзор

The goal of this pilot clinical trial is to examine the safety and feasibility of SCONE as home based therapy for orthostatic hypotension and bowel dysfunction in individuals with spinal cord injury or multiple system atrophy. The main aims of the study are: * To establish a safe protocol for home-based transcutaneous spinal cord stimulation therapy at the research centre * To test the safety and feasibility of home-based transcutaneous spinal cord stimulation therapy on orthostatic hypotension and bowel dysfunction Participation will last approximately 10 weeks (excluding screening period) and involves * Attending the study center to collect baseline evaluations and to plan where electrodes will be placed * A 2 week treatment period at the centre with 3 visits per week * A 6 week home based therapy period involving 1 hour treatments twice a day * Attending the study center to collect post-treatment evaluations

Подробное описание

Visit 1 - Screening

Visit 2 - Baseline Assessments

Visit 3 - Baseline EMG Mapping of Spinal Cord Segments with transcutaneous spinal cord stimulation

Visits 4-9 - Transcutaneous spinal cord stimulation

HOME-BASED Therapy (6 weeks)

Visit 10 - Post-treatment Autonomic Function Assessments

Visit 11 - Post-treatment Cardiac Function Assessments

Вмешательства

• Устройство Spinal COrd NEuromodulation ("SCONE") Device
  A non-invasive electrical device that provides transcutaneous spinal cord stimulation (TSCS) to the spinal cord by electrodes connected to a battery-powered source.

Первичные конечные точки

• Systolic blood pressure (SBP) changes in millimeters of mercury (mmHg) during TSCS [Срок оценки: 6 weeks]
• Blood pressure (BP) changes in millimeters of mercury (mmHg) in 24-hrs [Срок оценки: 6 weeks]

Вторичные конечные точки (3)

• 24-hour BP measurement in millimeters of mercury (mmHg) [Срок оценки: 6 weeks]
• Cardiovascular monitoring in mmHg [Срок оценки: 6 weeks]
• Adverse events (i.e., abnormal electrocardiograph) [Срок оценки: 6 weeks]

Критерии участия

Критерии включения

• A participant must meet all of the following criteria in order to be eligible for inclusion:

• Resident of British Columbia, Canada with active provincial medical services plan
• Male or female, 19-70 years of age The safety and feasibility of home-based non-invasive spinal cord stimulation for orthostatic hypotension in individuals with severe autonomic dysfunctions (H23-00192) Protocol Version 1.0, December 8, 2023 Page 6 of 23
• Chronic spinal cord injury (SCI) (non-progressive, with complete motor paralysis) at or above the T6 spinal segment OR Multiple System Atrophy (MSA) of the parkinsonian type.
• >1-year post injury or diagnosis, at least 6 months from any spinal surgery.
• American Spinal Injury Association Impairment Scale (AIS) A, B for SCI or having OH (Orthostatic Hypotension) for MSA.
• Willing and able to comply with all clinic visits and study-related procedures.
• Able to understand and complete study-related questionnaires (must be able to understand and speak English or have access to an appropriate interpreter as judged by the investigator).
• No painful musculoskeletal dysfunction, unhealed fracture, pressure sore, or active infection that may interfere with testing.
• Stable management of spinal cord related clinical issues (i.e., spasticity management).
• Women of childbearing potential must not be intending to become pregnant, currently pregnant, or lactating. The following conditions apply:

10.1. Women of childbearing potential must have a confirmed negative pregnancy test prior to the baseline visit.

10.2. Women of childbearing potential must agree to use adequate contraception during the period of the trial and for at least 28 days after completion of treatment. Effective contraception includes abstinence.

• Sexually active males with female partners of childbearing potential must agree to use effective contraception during the period of the trial and for at least 28 days after completion of treatment.
• Must provide informed consent.

Критерии исключения

• A participant who meets any of the following criteria will be ineligible to participate:

• Ventilator dependent.
• Clinically significant, unmanaged, depression (PHQ-9 above 15) or ongoing drug abuse.
• Use of any medication or treatment that in the opinion of the investigator indicates that it is not in the best interest of the participant to participate in this study.
• Intrathecal baclofen pump.
• Cardiovascular, respiratory, bladder, or renal disease unrelated to spinal cord injury (SCI) or presence of hydronephrosis or presence of obstructive renal stones.
• Presence of severe acute medical issue that in the investigator's judgement would adversely affect the participant's participation in the study. Examples include, but are not limited to acute urinary tract infections, active heterotopic ossification, newly changed antidepressant medications \[tricyclics\], debilitating muscle pain, pressure sores, or unstable diabetes.
• Any implanted metal (other than dental implants) in the skull or presence of pacemakers, stimulators, or medication pumps in the trunk.
• Takes more than 40mg of Baclofen per day.
• Severe anemia (Hgb<8 g/dl or Hgb,80 g/L) or hypovolemia as measured by hematocrit via blood test in the last six months.
• Participant is a member of the investigational team or his/her immediate family.
• Participant has undergone electrode implantation surgery.

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

Лечение

Центры проведения

Канада · 1 центр

• ICORD, Blusson Spinal Cord Centre — Vancouver

Идентификаторы

NCT: NCT06838637 · H23-00192

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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