Comparing Prism Adaptation Training With and Without TENS to Minimize Unilateral Spatial Neglect
Part of paid clinical trials in Centerville, Ohio.
- Sponsor
- Kettering Health Network
- Study ID
- NCT07157865
- Status
- Recruiting
Conditions
- Stroke
- Unilateral Spatial Neglect
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Prism adaptation training combined with TENS — DEVICESubjects 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 — OTHERSubjects will receive prism adaptation training (PAT) only wearing prism goggles during a functional reaching task during occupational therapy.
Study Details
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.
Key Dates
- Start date
- Sep 30, 2025
- Status verified
- Mar 2026
- Primary completion
- Sep 30, 2028
- Completion
- Sep 30, 2028
Study Design
- Enrollment
- 20 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: PAT + TENS treatmentSubjects 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 onlySubjects 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.
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 ]
Central Contacts
- Rachelle M Janning, OTD, MS, OTR/L19372324443
- Michelle Pershing, PhD
Locations (2)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Kettering Health NeuroRehab and Balance Center | Centerville | Ohio | 45459 | Rachelle M Janning, OTD, MS, OTR/L, CAPS, CBIS |
| Kettering Health NeuroRehab and Balance Center | Centerville | Ohio | 45459 |
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