Comparing Prism Adaptation Training With and Without TENS to Minimize Unilateral Spatial Neglect

NCT07157865 | Recruiting FDA Device

• 1 other identifier: KHN-2025-113
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 2

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

Outcome Measures

Primary Outcomes (2)

• Change in unilateral spatial neglect functional deficits

  The Catherine Bergego Scale (CBS) is the selected outcome measure for assessing the severity of Unilateral Spatial Neglect (USN) and for evaluating changes in function and neglect following interventions. The CBS includes 10 subtests designed to identify both the presence and severity of USN. Maximum score on the CBS is 30 which indicates severe neglect, minumum score is 0 which indicates no neglect.

  From enrollment to discharge from therapy services which is typically 8-12 weeks

• Change in motor control deficits

  The Wolf Motor Function Test (WMFT) is a standardized assessment tool widely used to measure upper extremity motor abilities in individuals recovering from a stroke. This test serves as an outcome measure for motor control, assessing motor ability via a performance time and a Functional Ability Scale (FAS) of 15 subtests. During the timed tests subjects are allowed a maximum of 120 seconds per task. If a person cannot complete the task within 120 seconds the time is recorded as 120+. The official WFMT time score is the median time of 15 timed tasks. The FAS is calculated using a 6-point ordinal scale from 0-5. A higher score indicates better movement (0 = does not attempt to use the affected limb to 5=movement appears normal). The FAS score is calculated by averaging scores across all subtests.

  From time of enrollment to discharge from therapy services typically 8-12 weeks

Study Arms (2)

PAT + TENS treatment

EXPERIMENTAL

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.

Device: Prism adaptation training combined with TENS

PAT only

ACTIVE COMPARATOR

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.

Other: PAT only

Interventions

PAT only OTHER

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

PAT only

Prism adaptation training combined with TENS DEVICE

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 + TENS treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kettering Health Network: lead

Study Sites (2)

Kettering Health NeuroRehab and Balance Center

Centerville, Ohio, 45459, United States

NOT YET RECRUITING

Kettering Health NeuroRehab and Balance Center

Centerville, Ohio, 45459, United States

RECRUITING

Related Publications (8)

• Song C, Wu W, Feng N, Li Z, Lei B. Rehabilitative effects of Transcutaneous Electric Nerve Stimulation on limb function in stroke patients: a systematic review and meta-analysis. Disabil Rehabil. 2025 Sep;47(18):4645-4652. doi: 10.1080/09638288.2025.2453640. Epub 2025 Feb 11.

  PMID: 39930993 BACKGROUND

• Jacquin-Courtois S, O'Shea J, Luaute J, Pisella L, Revol P, Mizuno K, Rode G, Rossetti Y. Rehabilitation of spatial neglect by prism adaptation: a peculiar expansion of sensorimotor after-effects to spatial cognition. Neurosci Biobehav Rev. 2013 May;37(4):594-609. doi: 10.1016/j.neubiorev.2013.02.007. Epub 2013 Feb 18.

  PMID: 23428624 RESULT

• Fortis P, Ronchi R, Velardo V, Calzolari E, Banco E, Algeri L, Spada MS, Vallar G. A home-based prism adaptation training for neglect patients. Cortex. 2020 Jan;122:61-80. doi: 10.1016/j.cortex.2018.09.001. Epub 2018 Sep 18.

  PMID: 30314612 RESULT

• Eslami, S., Tahmasbi, F., Mohammadzadeh, S., Sanaie, S., Ghaderi, S., & Mamaghani, A.R.(2024). Application of transcutaneous electrical nerve stimulation (TENS) in stroke rehabilitation: An umbrella review. NeuroRegulation, 11(3), 304-325. doi:10.15540/nr.11.3.304

  RESULT

• Chen P, Hreha K, Gonzalez-Snyder C, Rich TJ, Gillen RW, Parrott D, Barrett AM. Impacts of Prism Adaptation Treatment on Spatial Neglect and Rehabilitation Outcome: Dosage Matters. Neurorehabil Neural Repair. 2022 Aug;36(8):500-513. doi: 10.1177/15459683221107891. Epub 2022 Jun 8.

  PMID: 35673990 RESULT

• Chen P, Diaz-Segarra N, Hreha K, Kaplan E, Barrett AM. Prism Adaptation Treatment Improves Inpatient Rehabilitation Outcome in Individuals With Spatial Neglect: A Retrospective Matched Control Study. Arch Rehabil Res Clin Transl. 2021 May 19;3(3):100130. doi: 10.1016/j.arrct.2021.100130. eCollection 2021 Sep.

  PMID: 34589681 RESULT

• Chen, P., et al. (2015). Relationship between visual neglect and rehabilitation outcomes in stroke patients: A meta-analysis. American Journal of Physical Medicine & Rehabilitation, 94(7), 567-578.

  RESULT

• Champod AS, Frank RC, Taylor K, Eskes GA. The effects of prism adaptation on daily life activities in patients with visuospatial neglect: a systematic review. Neuropsychol Rehabil. 2018 Jun;28(4):491-514. doi: 10.1080/09602011.2016.1182032. Epub 2016 May 16.

  PMID: 27181587 RESULT

MeSH Terms

Conditions

Stroke

Interventions

Transcutaneous Electric Nerve Stimulation

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Physical Therapy Modalities; Rehabilitation; Analgesia; Anesthesia and Analgesia

Study Officials

• Rachelle M Janning, OTD, MS, OTR/L

  Kettering Health/Northern Kentucky University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rachelle M Janning, OTD, MS, OTR/L

CONTACT

19372324443; rachelle.janning@ketteringhealth.org

Michelle Pershing, PhD

CONTACT

michelle.pershing@ketteringhealth.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 28, 2025
• First Posted: September 5, 2025
• Study Start: September 30, 2025
• Primary Completion (Estimated): September 30, 2028
• Study Completion (Estimated): September 30, 2028
• Last Updated: March 23, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Data will be available from December 15, 2027 to May 15, 2028
• Access Criteria: Data will be shared by the principle investigator by request for data analysis to address research questions.

Locations

US (2)