Improving Measurement and Treatment of Post-stroke Neglect

Обзор

This study examines how to best assess and treat post-stroke neglect. This study will examine the preliminary effects of an innovative intervention (repetitive task-specific practice + transcranial direct current stimulation) for individuals with neglect. This study will also determine whether items from various neglect assessments can be combined to establish a more comprehensive neglect measure.

Подробное описание

It is very common for stroke survivors to have difficulty attending to one side of their body or space (neglect). Stroke survivors with neglect not only demonstrate impairments in attention but they also experience motor impairment. These individuals also have an imbalance in excitation in the brain. This study will examine the preliminary effects of non-invasive brain stimulation (transcranial direct current stimulation, tDCS) combined with arm rehabilitation training (repetitive task-specific practice, RTP) for individuals with neglect following stroke. The investigators will examine the effects of the intervention on brain excitability, upper extremity motor impairment, and attentional impairment. This study will also examine assessment of neglect. There are many clinical assessments designed to assess neglect; however, it is unknown whether items from some of the most commonly used assessments are able to effectively measure neglect or whether items from these assessments can be combined. Clinicians rely on clinical assessments to inform treatment and document patient progress. Therefore, it is important that investigators more closely examine these existing assessments.

Вмешательства

• Устройство Sham tDCS
  Sham tDCS will be delivered for 30 minutes in conjunction with repetitive task-specific practice for the arm/hand. tDCS is a form of noninvasive brain stimulation. Electrodes will be placed on the scalp but in the sham condition they will not deliver direct current (2mA). Sham tDCS will be delivered for 30 minutes in conjunction with repetitive task-specific practice for the arm/hand. Repetitive task-specific practice (RTP). Participants will practice using their paretic arm/hand to complete fu
• Устройство Active tDCS
  Sham tDCS will be delivered for 30 minutes in conjunction with repetitive task-specific practice for the arm/hand. tDCS is a form of noninvasive brain stimulation. Electrodes will be placed on the scalp but in the sham condition they will not deliver direct current (2mA). Sham tDCS will be delivered for 30 minutes in conjunction with repetitive task-specific practice for the arm/hand. Repetitive task-specific practice (RTP). Participants will practice using their paretic arm/hand to complete fu

Первичные конечные точки

• Change in excitability of fronto-parietal connectivity [Срок оценки: Participants will be assessed at baseline and 30 minutes later]

Вторичные конечные точки (2)

• Change in upper extremity kinematics [Срок оценки: Participants will be assessed at baseline and 30 minutes later]
• Change on Behavioral Inattention Test [Срок оценки: Participants will be assessed at baseline and 1.5 hours later (immediately following experimental condition)]

Критерии участия

Критерии включения

• Ischemic or hemorrhagic stroke 3 months post stroke.
• Fugl-Meyer Upper Extremity (FMA-Upper Extremity) score between 20-56/60
• Inducible motor evoked potential (MEP) of the abductor pollicis brevis (APB) on the paretic stimulation (TMS)
• Demonstrate the presence of unilateral neglect (Virtual Reality Lateralized Attention Test score <18)

Критерии исключения

• History of cortical hemorrhagic stroke
• Presence of any MRI, TMS, tDCS risk factors including:

• history of seizures
• history of brain tumor
• hardware in skull or spine (e.g. coils, clips)
• implantable medical device (e.g. pacemaker)
• metal in body (not compatible with MRI)
• pregnancy
• Severe spasticity (Modified Ashworth Scale score 3)
• Severe aphasia or cognitive impairment limiting participants' comprehension (National Institutes of Health Stroke Scale Level of Consciousness Commands Item score 1 or Best Language Item score 2)
• Unable to travel to UE Motor Function Laboratory at the Center for Rehabilitation Research in Neurological Conditions (a collaborative, MOU approved, research center Ralph H. Johnson VA Medical Center and the Medical University of South Carolina) for the study

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Перекрёстный дизайн

Маскирование

Тройное слепое

Основная цель

Другое

Центры проведения

США · 1 центр

• VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA — Pittsburgh

Публикации

• Longley V, Hazelton C, Heal C, Pollock A, Woodward-Nutt K, Mitchell C, Pobric G, Vail A, Bowen A. Non-pharmacological interventions for spatial neglect or inattention following stroke and other non-progressive brain injury. Cochrane Database Syst Rev. 2021 Jul 1;7(7):CD003586. doi: 10.1002/14651858.CD003586.pub4. PMID 34196963

Идентификаторы

NCT: NCT03317860 · N2420-W · 1IK2RX002420-01A2

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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