Spatial-Motor Stroke-Rehab Study

Официальное название

Novel Spatial-Motor Approaches to Improve Spatial Neglect and Walking Deficits Post-Stroke

Обзор

The purpose of this study is to understand how prism adaptation training with and without electrical stimulation changes visuospatial behavior, motor system neurophysiology, and walking dysfunction.

Подробное описание

Spatial Neglect (SN) is defined as pathological asymmetric spatial behavior causing functional disability and occurs in greater than 50% of individuals with right hemisphere stroke. SN post-stroke is associated with increased fall risk, increased hospital length of stay, poorer rehabilitation outcomes, and severe long-term disability. Prism adaptation therapy (PAT) is an evidence-based treatment for SN after stroke, however, the effects of SN on gait are not well known. Neuromuscular electrical stimulation delivered via surface electrodes is a common therapeutic adjunct in stroke rehabilitation, including for SN and gait training. However, the additive therapeutic effects of combining electrical stimulation and PAT, as well as the effects of motor training on gait deficits associated with SN are poorly understood. Furthermore, although there is limited literature examining the effects of electrical stimulation on corticospinal tract output (CST), there is an inadequate understanding of the neural mechanisms of PAT and the combinatorial effects of PAT with electrical stimulation. To parse out the neural mechanisms of PAT and electrical stimulation on the visuospatial system, researchers will first examine the effects of PAT with or without electrical stimulation in neurologically unimpaired adults, researchers will then compare results to individuals with stroke with spatial neglect.

The primary objective is to study the effects of PAT on visuospatial behavior and motor cortical excitability in able-bodied individuals (young and older), and on spatial neglect, motor cortical neurophysiology, and walking function in individuals post-stroke.

The long-term goal of this project is to develop novel, effective, and personalized rehabilitation protocols targeting SN deficits and gait dysfunction to reduce disability in stroke survivors. The rationale of this project is to explore and generate data regarding future novel combinatorial motor-spatial retraining approaches that will enhance the rehabilitation approach of SN and gait performance in individuals post-stroke.

Вмешательства

• Устройство Prism adaptation therapy (PAT) + Electrical stimulation (E-stim)
  PAT requires one to wear prism lenses while making arm-reaching movements toward visual targets. For treating left-sided neglect, a person wears the prism lenses that shift the visual field, including the images of the target and of one's own reaching arm, certain degrees to the right depending on the diopter of the lens (e.g., the 20-diopter lens shifts the visual field by 11.4 degrees). The visual system adapts over the repetitive practice of the arm reaching toward the target. The person even
• Устройство Prism adaptation therapy (PAT) + Sham Stimulator
  Participants in the PAT with sham stim condition group will receive sham electrical stimulation treatment (electrodes will be attached but the stimulator will not be turned on) to the left upper limb with the same placement of electrodes while undergoing PAT.
• Другое Gait Training
  After PAT, participants will complete multiple 30-seconds to 4-minute bouts of walking on the treadmill or overground at speeds ranging from self-selected to fast speeds (faster than comfortable self-selected speed), with rest breaks between bouts.

Первичные конечные точки

• Change in visuospatial pointing behavior [Срок оценки: Pre-training and immediately after training session]
• Change in intracortical excitability [paired pulse transcranial Magnetic Stimulation (TMS)] [Срок оценки: Pre-training and immediately after training session]
• Change in corticospinal excitability (single pulse TMS) [Срок оценки: Pre-training and immediately after training session]

Вторичные конечные точки (4)

• Change in spatial neglect deficits [Срок оценки: Pre-training and immediately after training session]
• Change in computerized line bisection task [Срок оценки: Pre-training and immediately after training session]
• Change in the Catherine Bergego Scale (CBS) [Срок оценки: Pre-training and immediately after training session]
• Change in weight-bearing asymmetry [Срок оценки: Pre-training and immediately after training session]

Критерии участия

Критерии включения

Young Adults Able Bodied (YAB) Individuals

• 18-30 years
• Able-Bodied (healthy without any physical disability or neurological disorder)

Older Adults Able-Bodied Individuals (OAB)

• 45-90 years
• Able-Bodied (healthy without any physical disability or neurological disorder)

Individuals with right hemisphere stroke (40-90 years)

• >3 months following stroke.
• Presence of Aiming SN
• Ability to walk >10m with or without assistive devices.
• Unilateral left-sided hemiparesis with gross arm strength of ≤ grade 4/5 on the Medical Research Council Scale
• Ability to follow 3-stage commands and provide informed consent.

Критерии исключения

Young Adults Able-Bodied (YAB) Individuals and Older Adults Able-Bodied Individuals (OAB)

• History or evidence of orthopedic or physical disability
• History or evidence of neurological pathology
• Pregnancy (female)
• Uncontrolled hypertension
• Cardiac pacemaker or other implanted electronic system
• Presence of skin conditions preventing the electrical stimulation setup
• Impaired sensation in the left upper limb.
• Bruises or cuts at the stimulation electrode placement site
• Concurrent enrollment in rehabilitation or another investigational study.
• History or evidence of orthopedic or physical disability interfering with study procedures
• History or evidence of neurological pathology or disorder
• Severe uncontrolled medical problems (e.g., hypertension, cardiovascular disease, rheumatoid arthritis, active cancer or renal disease, epilepsy) that may interfere with study procedures
• Contraindications to TMS, such as metal implants, medications that can increase cortical excitability, and unexplained dizziness in the past 6 months

Individuals with right hemisphere stroke (40-90 years)

• History or brainstem strokes
• Cerebellar disorders
• Impaired sensation in the left upper limb.
• History of other neurological disorders
• Uncontrolled hypertension
• Cardiac pacemaker or other implanted electronic system
• Pregnancy (female)
• Presence of skin condition
• Bruises at the electrode placement site
• Severe uncontrolled medical problems (e.g., hypertension, cardiovascular disease, rheumatoid arthritis, active cancer or renal disease, epilepsy) or other medical conditions that can interfere with study procedures
• Contraindications to TMS, such as metal implants in the brain, medications that will increase cortical excitability, etc.

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Перекрёстный дизайн

Маскирование

Двойное слепое

Основная цель

Другое

Центры проведения

США · 3 центра

• Emory Rehabilitation Hospital — Atlanta
• Emory University Hospital (EUH) — Atlanta
• Executive Park — Atlanta

Идентификаторы

NCT: NCT06053320 · STUDY00005012 · 1F31NS131020-01 · 2025P009611

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗