Recruiting

PAT & TENS

Sponsor:

Kettering Health Network

Code:

NCT07157865

Conditions

Unilateral Spatial Neglect

Stroke

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Prism adaptation training combined with TENS

PAT only

Study Details

Brief summary:

This study aims to find out if doing two treatments together-Prism Adaptation Therapy (PAT) and Transcutaneous Electrical Nerve Stimulation (TENS)-will help people who have had a stroke pay better attention to one side of their body, better than just doing PAT by itself.

In addition to understanding how the intervention improves function the investigators would like to see if things like how old someone is, how long ago their stroke happened, where their brain was damaged, or how bad the neglect is, affect how well the treatment works.

To measure if the interventions make a difference the following outcome measures will be used.

Catherine Bergego Scale (CBS):

This is a test to see how severe someone's neglect is. Trained therapists use 10 simple tasks to check if a person is ignoring the left or right side.

Wolf Motor Function Test (WMFT):

This test checks how well a stroke survivor can move their arm. It helps the therapists see if the treatments improve movement and reaction time

People can join the study if they had a stroke, score at least "1" on the Catherine Bergego Scale, and they can understand and agree to take part in the study.

People cannot join the study if they have had more than two strokes, have or had seizures, or have a serious mental illness like schizophrenia, or have cancer in the arm that was affected by the stroke, they have a pacemaker or defibrillator in their body, and if they can't feel their arm on the side affected by the stroke

Once the study is done, the main results will be shared with the therapists who work at the NeuroRehab and Balance Center, like the physical, speech, and occupational therapists.

Conditions

Unilateral Spatial Neglect

Stroke

Study ID

NCT07157865

Start date

Sep 30, 2025

Status verified date

Mar, 2026

Completion date

Sep 30, 2028

Anticipated

Primary completion date

Sep 30, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • A diagnosis of stroke
  • Score 1 or above on the Catherine Bergego Scale
  • Cognitively able to consent

Exclusion Criteria:

  • Seizure disorder
  • Diagnosed with more than two strokes
  • Diagnosis of schizophrenia or schizoaffective disorder
  • Cancer diagnosis of upper extremity
  • Individuals with pacemakers and debrillators
  • Absent sensation of upper extremity affected by stroke

Study Design

Enrollment

20 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: PAT + TENS treatment

Subjects in this group will receive both prism adaptation training (PAT) and transcutaneous electrical nerve stimulation (TENS) during therapy sessions. Subjects will wear 20 diopter prism lenses that shift the visual field (for left neglect field is shifted to right, for right neglect field is shifted to the left) while reaching with either UE toward a target. The visual system and the motor system adapt over several reaches to align both the visual system and the motor system, and the target is reached. The client will wear the prism goggles during the functional reaching task while also using a TENS unit on their upper extremity on the neglected side of space to provide increased sensory awareness. TENS will be delivered using FDA-approved commercially available portable units.

active comparator: PAT only

Subjects will receive only prism adaptation training (PAT) during their therapy sessions. Subjects will wear 20 diopter prism lenses that shift the visual field (for left neglect field is shifted to right, for right neglect field is shifted to the left) while reaching with either UE toward a target. The visual system and the motor system adapt over several reaches to align both the visual system and the motor system, and the target is reached. The client will wear the prism goggles during the functional reaching task.

Interventions

Prism adaptation training combined with TENS

Subjects in the experimental group will receive both prism adaptation training and TENS to identify affects on USN. To date there are no published studies combining these treatments to minimize USN.

PAT only

Subjects will receive prism adaptation training (PAT) only wearing prism goggles during a functional reaching task during occupational therapy.

Primary outcome measure

  • Change in unilateral spatial neglect functional deficits [ Time Frame: From enrollment to discharge from therapy services which is typically 8-12 weeks ]
  • Change in motor control deficits [ Time Frame: From time of enrollment to discharge from therapy services typically 8-12 weeks ]

Central Contacts and Locations

Central contacts

Locations

Kettering Health NeuroRehab and Balance Center

Recruiting

Centerville, Ohio, United States, 45459

Contacts

More Information

Sponsor

Kettering Health Network

Last update posted

Mar 23, 2026

Last verified

Mar, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Kettering Health Network on 2026-03-23.