Меню
Идёт набор NCT06517043

Spinal Networks of Balance Learning and Retention in Older Adults

Без фазы С лечением Aging

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Balance Training, Spinal Active tsDCS, Spinal Sham tsDCS.
Кому может быть актуально
Состояния в реестре: Aging. Базовые параметры: 65 лет — 95 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

Upregulating Spinal Circuits to Enhance Balance and Walking and to Increase Spinal Excitability in Older Adults

Обзор

Age-related balance and walking issues increase fall risks, leading to injuries, higher healthcare costs, reduced quality of life, and increased morbidity/mortality rates. Preserving functional ability is a crucial public health priority, with the potential to reduce healthcare costs and enhance older adults' quality of life. Declines in balance and walking ability threaten independence. These declines are attributed to spinal network impairments and may be mitigated by targeted interventions aimed at addressing age-related spinal cord impairment to enhance functional outcomes. However, there is a lack of research into how the aging spinal cord affects balance/walking. In older adults, the spinal cord is less excitable, conducts signals more slowly, and is subject to neural noise. Intervening on age-related impairment of the spinal cord to improve balance/walking ability is a very promising but untapped area of research. A therapeutic approach that combines dynamic balance training with non-invasive electrical spinal stimulation may be effective in preserving functional abilities. This study tests whether electrical stimulation of the spinal lumbar regions is more beneficial than sham stimulation.

Подробное описание

A high proportion of older adults are currently or soon will be at risk for the well-known decline in walking and balance abilities that occur with aging. Preserving those abilities has become a major public health priority. Balance training can enhance functional abilities or attenuate functional decline; however, age-related motor deficits may impair practice-based motor learning and behavioral performance. Due to the crucial roles of the spinal cord in balance and walking performance, it is important to consider that age-related neural impairment of the spinal cord is a likely contributing factor. Specifically, the spinal cord in older adults has fewer neurons, is less excitable, and conducts signals more slowly.

Despite ample evidence of impaired spinal cord neuronal structure and function with aging, the potential benefit of an intervention targeting spinal control of balance and walking control has been largely unexplored. This dearth of research may be due in part to the lack of a clinically feasible intervention. However, the recent emergence of transcutaneous spinal direct current stimulation (tsDCS) as a non-invasive intervention creates new opportunities for understanding spinal cord contributions to balance and walking performance. Notably, our previous study was the first demonstration of the safety and feasibility of a lab-based intervention that combined tsDCS with complex walking practice. These initial findings support the enhanced efficacy of locomotor learning during a single session when combined with tsDCS in older adults. Building on the success of this preliminary data, the investigators now propose an extended, multisession intervention that combines tsDCS with balance training. The proposed study will be among the first multi-session trial to investigate the effects of tsDCS as an adjunct therapy to dynamic balance training in older adults.

This study aims to enroll 30 older adults aged 65 years or older with balance or walking deficits, determined through objective assessments. All participants will undergo the same five-session balance training over a 2-week period, which will emphasize the use of a unique balance exergaming device called the Dividat Senso. Participants will be randomly assigned to a tsDCS adjuvant group. The "Active group" will receive 30 continuous minutes of 2.5-mA tsDCS over lumbar regions T11/T12. The "Sham group" will receive the sham protocol, which involves an identical montage and stimulation arrangement but delivers no current for 27 minutes. Each 30-minutes session will be preceded and followed by balance and walking assessments to examine the intervention's effects over time. Spinal excitability, measured via soleus H-reflex testing, will be assessed immediately before and after tsDCS at the first and last intervention. Behavioral assessments will occur at baseline, 1 day post-intervention, and 10-day post-intervention to investigate pre vs. post effects and retention intervention effects. Prefrontal activity will be measured using functional near-infrared spectroscopy (fNIRS) during the behavioral assessments to evaluate demand on executive control networks.

The objective of using tsDCS is to upregulate spinal circuits to make them more responsive to task-specific activation, thereby fostering more robust learning and consolidation to enhance performance in dynamic balance tasks. Thus, the overarching hypothesis of the proposed research is that tsDCS will be a potent adjuvant therapy to a dynamic balance intervention by reinforcing task-appropriate spinal excitation to promote skill acquisition and retention, thereby improving balance and walking. This study will focus on achieving the following specific aims:

Specific Aim 1: Acquire preliminary effect size and response variance data to assess whether active adjuvant tsDCS therapy combined with dynamic balance training enhances practice-related gains in balance and walking performance and retention over time.

Specific Aim 2: Establish evidence of increased spinal excitability following tsDCS, positively correlating with gains in balance and walking functions.

The long term deliverable of this line of research will be a clinically feasible multi-modal intervention to assist in preserving motor function and independence in older adults. The knowledge and experience gained from this study will enable us to conduct larger studies to better understand the effects of aging on the spinal cord and to test rehabilitation interventions to promote healthy aging among older adults.

Вмешательства

  • Поведенческое Balance Training
    Complex balance task involving static and dynamic weight shifting and coordinated stepping
  • Устройство Spinal Active tsDCS
    Active tsDCS over lumbar regions
  • Устройство Spinal Sham tsDCS
    Sham tsDCS over lumbar regions

Первичные конечные точки

  • Center of Pressure (COP) balance control [Срок оценки: Baseline, 1-day post-intervention (after intervention), 10-day follow-up (after post-intervention)]
  • Walking speed over obstacle course [Срок оценки: Baseline, 1-day post-intervention (after intervention), 10-day follow-up (after post-intervention)]
  • Spinal excitability via Soleus H-reflex testing [Срок оценки: Baseline and immediately following 30-minute intervention]
Вторичные конечные точки (5)
  • Score on standardized balance assessment (Berg Balance Scale) [Срок оценки: Baseline, 1-day post-intervention (after intervention), 10-day follow-up (after post-intervention)]
  • Score on standardized walking assessment (Functional Gait Assessment) [Срок оценки: Baseline, 1-day post-intervention (after intervention), 10-day follow-up (after post-intervention)]
  • Completion time on test of executive function (Trail Making Test) [Срок оценки: Baseline, 1-day post-intervention (after intervention), 10-day follow-up (after post-intervention)]
  • tsDCS treatment-related adverse events as assessed by a survey questionnaire. [Срок оценки: Baseline and following 30-minute intervention]
  • Prefrontal cortical activity using fNIRS [Срок оценки: Baseline, 1-day post-intervention (after intervention), 10-day follow-up (after post-intervention)]

Критерии участия

Критерии включения

  • age range: 65 to 95 years
  • no severe high blood pressure: Resting systolic < 180 mmHg and diastolic < 100 mmHg
  • no severe vision impairment: Visual acuity ≥ 20/70 as determined by Snellen eye chart
  • walking problem: Preferred walking speed slower than 1.0 m/s over 10 meters
  • balance problem: Berg Balance Scale score < 45
  • no cognitive impairment: Montreal Cognitive Assessment (MoCA) score ≥ 26 out of 30

Критерии исключения

  • diagnosed neurological disorder or injury of the central nervous system, or observation of symptoms consistent with such a condition (Alzheimer's, Parkinson's, stroke, etc.)
  • severe arthritis, such as awaiting joint replacement
  • current cardiovascular, lung or renal disease; untreated diabetes; terminal illness
  • myocardial infarction or major heart surgery in the previous year
  • cancer treatment in the past year, except for nonmelanoma skin cancers and cancers having an excellent prognosis (e.g., early stage breast or prostate cancer)
  • current diagnosis of schizophrenia, other psychotic disorders, or bipolar disorder
  • currently taking medications that affect the central nervous system, such as benzodiazepines, anti-cholinergic medication, and GABAergic medication, among others
  • uncontrolled hypertension at rest (systolic > 180 mmHg and/or diastolic > 100 mmHg)
  • bone fracture or joint replacement in the previous six months
  • current enrollment in any other clinical trial
  • planning to relocate out of the area during the study period
  • non-English\* speaking, due to the likelihood of difficulties following instructions and communicating remotely
  • clinical judgment of the investigative team

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Тройное слепое
Основная цель
Лечение

Центры проведения

США · 1 центр
  • Malcom Randall VA Medical Center Brain Rehabilitation Research Center — Gainesville

Идентификаторы

NCT: NCT06517043 · IRB202400382 · R21AG084944

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗