Recruiting

Prism Adaptation Training & Electrical Stimulation

Sponsor:

Emory University

Code:

NCT06053320

Conditions

Spatial Neglect

Stroke

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Interventions

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

Prism adaptation therapy (PAT) + Sham Stimulator

Gait Training

Study Details

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

Study ID

NCT06053320

Start date

Apr 11, 2023

Status verified date

May, 2026

Completion date

Sep, 2026

Anticipated

Primary completion date

Sep, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

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 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.

Study Design

Enrollment

65 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Other

Interventions and Outcome Measures

Arms

active comparator: Young Able-Bodied individuals

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

active comparator: Old Able-Bodied individuals

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

experimental: Stroke with Spatial Neglect (SN) individuals

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

Interventions

Prism adaptation therapy (PAT) + Electrical stimulation (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 Stimulator

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 Training

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

  • Change in visuospatial pointing behavior [ Time Frame: Pre-training and immediately after training session ]
  • Change in intracortical excitability [paired pulse transcranial Magnetic Stimulation (TMS)] [ Time Frame: Pre-training and immediately after training session ]
  • Change in corticospinal excitability (single pulse TMS) [ Time Frame: Pre-training and immediately after training session ]

Central Contacts and Locations

Central contacts

Fisayo Aloba, PT, DPT

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

Locations

Emory Rehabilitation Hospital

Recruiting

Atlanta, Georgia, United States, 30322

Contacts

Fisayo Aloba, PT, DPT

olufisayo.aloba@emory.edu

Emory University Hospital (EUH)

Recruiting

Atlanta, Georgia, United States, 30322

Contacts

Fisayo Aloba, PT, DPT

olufisayo.aloba@emory.edu

Executive Park

Recruiting

Atlanta, Georgia, United States, 30329

Contacts

Fisayo Aloba, PT, DPT

olufisayo.aloba@emory.edu

More Information

Sponsor

Emory University

Last update posted

May 20, 2026

Last verified

May, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Emory University on 2026-05-20.