Spatial-Motor Stroke-Rehab Study

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

Interventions

DEVICE

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).

DEVICE

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.

OTHER

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.

Sponsors & Collaborators

• National Institute of Neurological Disorders and Stroke (NINDS)

  collaborator NIH

• Emory University

  lead OTHER

Principal Investigators

• Trisha Kesar, PT, PhD · Emory University

• Fisayo Aloba, PT, DPT · Emory University

Study Design

Allocation

RANDOMIZED

Purpose

OTHER

Masking

DOUBLE

Model

CROSSOVER

Eligibility

Min Age

18 Years

Max Age

90 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2023-04-11

Primary Completion

2026-09-30

Completion

2026-09-30

FDA Device

Yes

Countries

• United States

Study Locations