Stroke
Conditions
Keywords
perceptual disorders, cerebrovascular disorders, neurobehavioral manifestations, neurologic manifestations, neglect, non-invasive brain stimulation, rehabilitation, tDCS, paresis
Brief summary
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.
Detailed description
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.
Interventions
DEVICESham transcranial direct current stimulation (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 functional movements during the 30 minute train
DEVICEActive direct current stimulation (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 functional movements during the 30 minute train
Sponsors
VA Office of Research and Development
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Masking description
Participants will receive both conditions (active and sham transcranial direct current stimulation paired with arm rehabilitation training \[repetitive task-specific practice\]) in this cross-over design study. Individuals will be randomized to determine which condition they receive first and the participant and treatment therapist and assessor will be blinded to the order that the interventions are delivered. The PI will oversee randomization so that each patient is randomized and assigned a unique five digit code. When this code is entered on the tDCS device, the device will automatically assign the patient to receive either real or sham stimulation. Because the sham stimulation provides a ramp up/ramp down stimulation for 15 seconds at the start and end of the session the participant may perceive the sham stimulation as active stimulation.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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)
Exclusion criteria
* 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, Memorandum of Understanding (MOU) approved, research center Ralph H. Johnson VA Medical Center and the Medical University of South Carolina) for the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in excitability of fronto-parietal connectivity | Participants will be assessed at baseline and 30 minutes later | Excitability of fronto-parietal connectivity measured by paired pulse twin coil transcranial magnetic stimulation (TMS) test. In each session, the difference in excitability of fronto-parietal connectivity between pre and post stimulation will be measured. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in upper extremity kinematics | Participants will be assessed at baseline and 30 minutes later | A kinematic assessment will be conducted to assess changes in motor impairment. |
| Change on Behavioral Inattention Test | Participants will be assessed at baseline and 1.5 hours later (immediately following experimental condition) | A neglect assessment (conventional subtests) will be conducted to assess changes in attentional impairment. Total scores range from 0-146 with lower scores indicating greater impairment. |
Countries
United States
Contacts
CONTACTEmily S Grattan, PhD MS BS
PRINCIPAL_INVESTIGATOREmily S. Grattan, PhD MS BS
VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA
Outcome results
None listed