Clinical trial NCT06053320: Spatial-Motor Stroke-Rehab Study
Official title: Novel Spatial-Motor Approaches to Improve Spatial Neglect and Walking Deficits Post-Stroke
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Spatial Neglect
Stroke
Keywords: Post-stroke
Prism Adaptation Therapy (PAT)
Walking
Lead sponsor: Emory University
Sponsor class: OTHER
Collaborators: name: National Institute of Neurological Disorders and Stroke (NINDS)
First posted: 2023-09-25
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: After treatment, three weeks will be allowed for washout, then participants will receive the opposite (second) PAT condition with sham stim or electrical stimulation.
Primary purpose: OTHER

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

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.

Exclusion Criteria:

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 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, unexplained dizziness in the past 6 months

Individuals with right hemisphere stroke (40-90 years)

* History of multiple strokes 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
* Concurrent enrollment in rehabilitation or another investigational study
* 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.

Primary outcomes:
measure: Change in visuospatial pointing behavior
timeFrame: Pre-training and immediately after training session
measure: Change in intracortical excitability [paired pulse transcranial Magnetic Stimulation (TMS)]
timeFrame: Pre-training and immediately after training session
measure: Change in corticospinal excitability (single pulse TMS)
timeFrame: Pre-training and immediately after training session
Secondary outcomes:
measure: Change in spatial neglect deficits
timeFrame: Pre-training and immediately after training session
measure: Change in computerized line bisection task
timeFrame: Pre-training and immediately after training session
measure: Change in the Catherine Bergego Scale (CBS)
timeFrame: Pre-training and immediately after training session
measure: Change in weight-bearing asymmetry
timeFrame: Pre-training and immediately after training session
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Emory Rehabilitation Hospital
state: Georgia
city: Atlanta
country: United States
facility: Emory University Hospital (EUH)
state: Georgia
city: Atlanta
country: United States
facility: Executive Park
state: Georgia
Study officials:
affiliation: Emory University
name: Trisha Kesar, PT, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Emory University
name: Fisayo Aloba, PT, DPT
role: PRINCIPAL_INVESTIGATOR
References: