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Spatial NeglectNCT06053320

Spatial-Motor Stroke-Rehab Study

A study testing Prism adaptation therapy (PAT) + Electrical stimulation (E-stim) and Gait Training in people with Spatial Neglect and Stroke, run by Emory University at 3 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 90 yearsHealthy volunteers can take part
Conditions the study is for
Spatial Neglect, Stroke
What is being tested?
Prism adaptation therapy (PAT) + Electrical stimulation (E-stim) and Gait Training
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
65 participants
Where
3 sitesUnited States
Study dates
11 Apr 2023to Sep 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 90 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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)
Show all 12Show fewer
  • 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.

Who cannot join

  • 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
Show all 26Show fewer
  • 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.

Trial locations and contacts

3 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Fisayo Aloba, PT, DPT contact

404-712-5803

olufisayo.aloba@emory.edu

United States3 sites, 3 recruiting
  • Emory Rehabilitation Hospital

    Atlanta, Georgia, 30322

    Fisayo Aloba, PT, DPT, olufisayo.aloba@emory.edu

    Recruiting
  • Emory University Hospital (EUH)

    Atlanta, Georgia, 30322

    Fisayo Aloba, PT, DPT, olufisayo.aloba@emory.edu

    Recruiting
  • Executive Park

    Atlanta, Georgia, 30329

    Fisayo Aloba, PT, DPT, olufisayo.aloba@emory.edu

    Recruiting

Other trials in United States

About this study

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

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.

Read the 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.

Being tested
Prism adaptation therapy (PAT) + Electrical stimulation (E-stim), Prism adaptation therapy (PAT) + Sham Stimulator, Gait Training
Keywords
Post-stroke, Prism Adaptation Therapy (PAT), Walking
Medical subject headings
Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

    Also called PAT + 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 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).

  • Prism adaptation therapy (PAT) + Sham StimulatorDevice

    Also called Sham Stim

    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.

  • Gait TrainingOther

    Also called Gait Training After PAT

    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.

Study groups in NCT06053320
Study groupRoleWhat they receive
Young Able-Bodied individualsActive comparator18-30 years old able-bodied individuals (healthy without any physical disability or neurological disorder).
Receives: Device: Prism adaptation therapy (PAT) + Electrical stimulation (E-stim); Device: Prism adaptation therapy (PAT) + Sham Stimulator
Old Able-Bodied individualsActive comparator45-90 years old able-bodied individuals (healthy without any physical disability or neurological disorder).
Receives: Device: Prism adaptation therapy (PAT) + Electrical stimulation (E-stim); Device: Prism adaptation therapy (PAT) + Sham Stimulator
Stroke with Spatial Neglect (SN) individualsExperimental40-90 years individuals with more than 3 months following right hemisphere stroke.
Receives: Device: Prism adaptation therapy (PAT) + Electrical stimulation (E-stim); Device: Prism adaptation therapy (PAT) + Sham Stimulator; Other: Gait Training

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Pre-training and immediately after training session

  2. 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.

    Measured: Pre-training and immediately after training session

  3. 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.

    Measured: Pre-training and immediately after training session

Secondary outcomes (4)
  1. 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.

    Measured: Pre-training and immediately after training session

  2. 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

    Measured: Pre-training and immediately after training session

  3. 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

    1. = mild neglect (patient always explores the right hemispace first and slowly or hesitantly explores the left side)
    2. = moderate neglect (patient demonstrates constant and clear left-sided omissions or collisions)
    3. = 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

    Measured: Pre-training and immediately after training session

  4. 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.

    Measured: Pre-training and immediately after training session

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Sep 2023
  2. Study start11 Apr 2023
  3. Primary completionSep 2026 (estimated)
  4. Study completionSep 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Crossover
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
Double blind
Who is masked
Participant, Care provider
Enrolment
65 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06053320
Sponsor's protocol ID
STUDY00005012
Other IDs
1F31NS131020-01, 2025P009611
Status last verified
May 2026
First submitted
1 Sep 2023
Last updated
20 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
Yes: The research team will share sex, age, race, and summary statistics for the results of the study (primary and secondary outcomes)

Questions about this trial

What is this clinical trial studying?

A study testing Prism adaptation therapy (PAT) + Electrical stimulation (E-stim) and Gait Training in people with Spatial Neglect and Stroke, run by Emory University at 3 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 20 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Fisayo Aloba, PT, DPT (404-712-5803, olufisayo.aloba@emory.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in visuospatial pointing behavior (time frame: Pre-training and immediately after training session). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2026.

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