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Spatial-Motor Stroke-Rehab Study

Primary Purpose

Spatial Neglect, Stroke

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Prism adaptation therapy (PAT) + Electrical stimulation (E-stim)

Prism adaptation therapy (PAT) + Sham Stimulator

Gait Training

About this trial

This is an interventional other trial for Spatial Neglect focused on measuring Post-stroke, Prism Adaptation Therapy (PAT), Walking

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

Emory Rehabilitation HospitalRecruiting
Emory University Hospital (EUH)Recruiting
Executive ParkRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Arm Label

Young Able-Bodied individuals

Old Able-Bodied individuals

Stroke with Spatial Neglect (SN) individuals

Arm Description

18-30 years old able-bodied individuals (healthy without any physical disability or neurological disorder).

45-90 years old able-bodied individuals (healthy without any physical disability or neurological disorder).

40-90 years individuals with more than 3 months following right hemisphere stroke.

Outcomes

Primary Outcome Measures

Change in visuospatial pointing behavior

Measured by the neuropsychological laboratory pointing behavior with the Kessler Foundation Neglect Assessment Process (KF-NAP) tool. Patients are asked to point with their eyes closed towards the center (proprioceptive pointing) and eyes open towards a target (visuo-proprioceptive pointing) on a standing calibrated board unaffected hand). The test is scored by measuring the deviation from 0 (midline). Pre-PAT and post-PAT measures are compared, there is no minimum or maximum score. A more negative score (Pre to Post) means improvement in visuospatial alignment (Improved left spatial neglect) in people post-stroke.

Change in intracortical excitability [paired pulse transcranial Magnetic Stimulation (TMS)]

Primary Motor Cortex (M1) and TMS from the hand muscles (first dorsal interossei) and the ankle (soleus) will be measured using Computer software (Biopac) that will record the muscle's responses to TMS pulses (MEPs) through electromyography (EMG) sensors attached to the skin of the legs and/or arms.

Change in corticospinal excitability (single pulse TMS)

Change in corticospinal excitability measured by the change from baseline in motor evoked potentials (MEP) amplitude responses from the hand muscles (first dorsal interossei) and the ankle (soleus) will be measured using Computer software (Biopac) that will record the muscle's responses to TMS pulses (MEPs) through electromyography (EMG) sensors attached to the skin of the legs and/or arms.

Secondary Outcome Measures

Change in spatial neglect deficits

Measured by the clinical tests Behavioral Inattention Test (BIT). The BIT Conventional (BITC) subtest consists of 6 items: line crossing, letter cancelation, star cancellation, figure and shape copying, line bisection, and representational drawing. The Cut-offs score for the BITC is 129 out of 146. Higher scores are indicative of more severe visual impairment.

Change in computerized line bisection task

Participants are asked to perform the conventional 24cm line bisection task on a 14-inch screen computer screen, placed 55cm from a seated position, with the unaffected hand using a mouse. There are 64 lines, half of which are in normal condition and half in reversed condition. The test is scored by measuring the deviation of the bisection from the true center of the line. A deviation negative of zero (0) is indicative of spatial neglect; Pre-PAT and post-PAT measures are compared, and a negative score reflects a shift to the left visual space- the effect of PAT

Change in the Catherine Bergego Scale (CBS)

Measured by a validated assessment tool that is sensitive to SN and its functional sequela; CBS motor items have been validated to identify Aiming SN. The CBS uses a 4-point rating scale to indicate the severity of neglect for each item: 0 = no neglect = mild neglect (patient always explores the right hemispace first and slowly or hesitantly explores the left side) = moderate neglect (patient demonstrates constant and clear left-sided omissions or collisions) = severe neglect (patient is only able to explore the right hemispace) This results in a total score of 30. Reported arbitrary ratings of neglect severity according to total scores: 0 = No behavioral neglect 1-10 = Mild behavioral neglect 11-20 = Moderate behavioral neglect 21-30 = Severe behavioral neglect

Change in weight-bearing asymmetry

This outcome will be measured only in participants who have had a stroke. Force platform data obtained from a dual-belt instrumented treadmill during 3-d motion capture will be used to calculate inter-limb asymmetry in vertical ground reaction forces in standing and during the stance phase of gait.

Full Information

NCT ID

NCT06053320

First Posted

September 1, 2023

Last Updated

September 22, 2023

Sponsor

Emory University

Collaborators

National Institute of Neurological Disorders and Stroke (NINDS)

1. Study Identification

Unique Protocol Identification Number

NCT06053320

Brief Title

Spatial-Motor Stroke-Rehab Study

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2023

Overall Recruitment Status

Recruiting

Study Start Date

April 11, 2023 (Actual)

Primary Completion Date

December 1, 2024 (Anticipated)

Study Completion Date

December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Emory University

Collaborators

National Institute of Neurological Disorders and Stroke (NINDS)

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Spatial Neglect, Stroke

Keywords

Post-stroke, Prism Adaptation Therapy (PAT), Walking

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

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.

Masking

ParticipantCare Provider

Masking Description

Both experiments include a sham condition: Sham electrical stimulation consisting of electrode placement with the stimulator turned off.

Allocation

Randomized

Enrollment

35 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Young Able-Bodied individuals

Arm Type

Active Comparator

Arm Description

18-30 years old able-bodied individuals (healthy without any physical disability or neurological disorder).

Arm Title

Old Able-Bodied individuals

Arm Type

Active Comparator

Arm Description

45-90 years old able-bodied individuals (healthy without any physical disability or neurological disorder).

Arm Title

Stroke with Spatial Neglect (SN) individuals

Arm Type

Experimental

Arm Description

40-90 years individuals with more than 3 months following right hemisphere stroke.

Intervention Type

Device

Intervention Name(s)

Prism adaptation therapy (PAT) + Electrical stimulation (E-stim)

Other Intervention Name(s)

PAT + E-stim

Intervention Description

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 eventually achieves success with a leftward movement reaching the actual target. Electrical stimulation (E-stim) involves parameters and settings commonly used in clinical practice as well as research for pain relief and other applications, commonly referred to as transcutaneous electrical nerve stimulation (TENS). TENS and E-stim are delivered using FDA-approved, commercially available portable clinical transcutaneous electrical stimulators (e.g. Empi TENS Unit).

Intervention Type

Device

Intervention Name(s)

Prism adaptation therapy (PAT) + Sham Stimulator

Other Intervention Name(s)

Sham Stim

Intervention Description

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.

Intervention Type

Other

Intervention Name(s)

Gait Training

Other Intervention Name(s)

Gait Training After PAT

Intervention Description

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.

Primary Outcome Measure Information:

Title

Change in visuospatial pointing behavior

Description

Time Frame