Spatial-Motor Stroke-Rehab Study

NCT06053320 | Recruiting FDA Device

• 2 other identifiers: STUDY000050121F31NS131020-01
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 3

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.

Conditions

Spatial Neglect; Stroke

Keywords

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

Outcome Measures

Primary Outcomes (3)

• 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.

  Pre-training and immediately after training session

• 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.

  Pre-training and immediately after training session

• 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.

  Pre-training and immediately after training session

Secondary Outcomes (4)

• Change in spatial neglect deficits

  Pre-training and immediately after training session

• Change in computerized line bisection task

  Pre-training and immediately after training session

• Change in the Catherine Bergego Scale (CBS)

  Pre-training and immediately after training session

• Change in weight-bearing asymmetry

  Pre-training and immediately after training session

Study Arms (3)

Young Able-Bodied individuals

ACTIVE COMPARATOR

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

Device: Prism adaptation therapy (PAT) + Electrical stimulation (E-stim); Device: Prism adaptation therapy (PAT) + Sham Stimulator

Old Able-Bodied individuals

ACTIVE COMPARATOR

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

Device: Prism adaptation therapy (PAT) + Electrical stimulation (E-stim); Device: Prism adaptation therapy (PAT) + Sham Stimulator

Stroke with Spatial Neglect (SN) individuals

EXPERIMENTAL

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

Device: Prism adaptation therapy (PAT) + Electrical stimulation (E-stim); Device: Prism adaptation therapy (PAT) + Sham Stimulator; Other: Gait Training

Interventions

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

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).

Also known as: PAT + E-stim

Old Able-Bodied individuals; Stroke with Spatial Neglect (SN) individuals; Young Able-Bodied individuals

Prism adaptation therapy (PAT) + Sham Stimulator DEVICE

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.

Also known as: Sham Stim

Old Able-Bodied individuals; Stroke with Spatial Neglect (SN) individuals; Young Able-Bodied individuals

Gait Training OTHER

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.

Also known as: Gait Training After PAT

Stroke with Spatial Neglect (SN) individuals

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Young Adults Able Bodied (YAB) Individuals
• years
• Able-Bodied (healthy without any physical disability or neurological disorder)
• Older Adults Able-Bodied Individuals (OAB)
• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Emory University: lead
• National Institute of Neurological Disorders and Stroke (NINDS): collaborator

Study Sites (3)

Emory Rehabilitation Hospital

Atlanta, Georgia, 30322, United States

RECRUITING

Emory University Hospital (EUH)

Atlanta, Georgia, 30322, United States

RECRUITING

Executive Park

Atlanta, Georgia, 30329, United States

RECRUITING

MeSH Terms

Conditions

Stroke

Interventions

Electric Stimulation

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Physical Stimulation; Investigative Techniques

Study Officials

• Trisha Kesar, PT, PhD

  Emory University

  PRINCIPAL INVESTIGATOR

• Fisayo Aloba, PT, DPT

  Emory University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Fisayo Aloba, PT, DPT

CONTACT

404-712-5803; olufisayo.aloba@emory.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: Both experiments include a sham condition: Sham electrical stimulation consisting of electrode placement with the stimulator turned off.
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: After treatment, three weeks will be allowed for washout, then participants will receive the opposite (second) PAT condition with sham stim or electrical stimulation.

Study Record Dates

• First Submitted: September 1, 2023
• First Posted: September 25, 2023
• Study Start: April 11, 2023
• Primary Completion: March 1, 2026
• Study Completion: March 1, 2026
• Last Updated: October 16, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Data will be available from April 1, 2025 to September 1, 2025
• Access Criteria: Data will be shared by request by principal investigators (PIs) for data analysis to address ancillary research questions. Data will be available in data repositories e.g. DANDI.

Locations

US (3)