Unilateral Spatial NeglectNCT07157865
Comparing Prism Adaptation Training With and Without TENS to Minimize Unilateral Spatial Neglect
A study testing Prism adaptation training combined with TENS and PAT only in people with Unilateral Spatial Neglect and Stroke, run by Kettering Health Network at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Unilateral Spatial Neglect, Stroke
- What is being tested?
- Prism adaptation training combined with TENS and PAT only
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 2 sitesUnited States
- Study dates
- 30 Sep 2025to 30 Sep 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- A diagnosis of stroke
- Score 1 or above on the Catherine Bergego Scale
- Cognitively able to consent
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Michelle Pershing, PhD contact
United States2 sites, 2 recruiting
- Not yet recruiting
Kettering Health NeuroRehab and Balance Center
Centerville, Ohio, 45459
Rachelle M Janning, OTD, MS, OTR/L, CAPS, CBIS
- Recruiting
Kettering Health NeuroRehab and Balance Center
Centerville, Ohio, 45459
Rachelle Janning, OTD, 937-232-4443, janningr2@nku.edu
Kristin Mclean, DPT, 937-401-6109, kristin.mclean@ketteringhealth.org
About this study
Official title: A Comparison of Prism Adaptation Training (PAT) Paired With Transcutaneous Electrical Stimulation (TENS) vs PAT Alone on Outcomes in Post-Stroke Patients Experiencing Unilateral Spatial Neglect (USN)
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.
Read more
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.
Read the detailed description
Unilateral spatial neglect (USN) is a common and disabling consequence of stroke, particularly following right-hemisphere lesions, affecting up to 50-70% of survivors. USN impairs a patient's ability to attend to or interact with stimuli on the side opposite the brain lesion, leading to significant challenges in daily functioning and rehabilitation engagement. The presence of USN is associated with poorer functional outcomes, increased dependence, and prolonged recovery after a stroke. Prism Adaptation Training (PAT) is a non-invasive intervention that has emerged as a promising approach for USN rehabilitation. PAT involves repeated visuomotor activities while wearing prism glasses that shift the visual field, promoting adaptation and recalibration of spatial attention. Multiple studies and systematic reviews have demonstrated that PAT can improve neglect symptoms, enhance motor control of the affected limb, and improve activities of daily living (ADL), with effects persisting for weeks to months post-intervention. However, the optimal dosing, duration, and potential for augmenting the effects of PAT remain areas of ongoing investigation. Transcutaneous Electrical Nerve Stimulation (TENS) is another non-invasive modality widely used in post-stroke rehabilitation. TENS delivers mild electrical currents through the skin to stimulate nerves and has shown efficacy in improving motor function, reducing spasticity, and enhancing functional recovery in stroke survivors. It has been shown to enhance upper limb function in individuals who have experienced a stroke. While TENS is primarily used for motor and sensory rehabilitation, its potential to modulate cortical excitability and facilitate neuroplasticity suggests it may also influence cognitive domains, including attention and spatial processing. There is evidence suggesting that TENS can have an impact on neglect. Despite the individual benefits of PAT and TENS in post-stroke rehabilitation, limited research has explored their combined effects on USN. The rationale for pairing PAT with TENS is based on the hypothesis that TENS-induced sensory stimulation may help enhance awareness of neglected space when applied to the upper extremity of individuals experiencing neglect, thereby potentially amplifying the adaptive effects of PAT on spatial neglect. However, the synergistic potential of TENS to enhance cognitive-perceptual rehabilitation strategies like PAT in the context of USN has not been systematically investigated. Given the persistent functional burden of USN and the need for more effective and accessible rehabilitation protocols, a pilot study comparing PAT paired with TENS versus PAT alone could provide critical preliminary evidence. Such research may identify whether adjunctive TENS can accelerate or enhance recovery from neglect, inform optimal intervention strategies, and ultimately improve independence and quality of life for stroke survivors experiencing USN.
The research question:
Is the combination of Prism Adaptation Therapy (PAT) and Transcutaneous Electrical Nerve Stimulation (TENS) more effective than PAT alone in reducing unilateral spatial neglect (USN) in individuals' post-stroke?
Hypothesis: The combination of Prism Adaptation Therapy (PAT) and Transcutaneous Electrical Nerve Stimulation (TENS) will be more effective than PAT alone in reducing unilateral spatial neglect (USN) in individuals post-stroke.
Primary study aim:
To evaluate whether the combination of Prism Adaptation Therapy (PAT) and Transcutaneous Electrical Nerve Stimulation (TENS) is more effective than PAT alone in reducing unilateral spatial neglect (USN) in individuals post-stroke.
Secondary study aims: To investigate whether patient characteristics (e.g. time since stroke, lesion location, severity of neglect, gender, age) influence the effectiveness of the combined intervention. To investigate the effects of the PAT alone and the combined PAT and TENS intervention on functional outcomes related to USN. To investigate the impact of PAT alone and the combined PAT and TENS intervention on the motor control of the neglected limb.
The main study outcome measures include:
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. All occupational therapists at the NeuroRehab and Balance Center (NRBC) have been trained in the proper administration and scoring of the CBS to ensure accurate results. It is standard protocol at NRBC clinic that all patients diagnosed with stroke are evaluated for potential USN using the CBS, which is routinely administered in these cases. In 2014, the Kessler Foundation published guidelines on how to administer the CBS.
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, helping to assess improvements in movement quality and reaction time following interventions. All occupational therapists at the NeuroRehab and Balance Center (NRBC) have received training in the administration and scoring of the WMFT, and it is standard protocol at NRBC that all patients diagnosed with stroke are evaluated using the WMFT.
- Conditions
- Unilateral Spatial Neglect, Stroke
- Being tested
- Prism adaptation training combined with TENS, PAT only
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prism adaptation training combined with TENSDevice
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 onlyOther
Subjects will receive prism adaptation training (PAT) only wearing prism goggles during a functional reaching task during occupational therapy.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: PAT only |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: From time of enrollment to discharge from therapy services typically 8-12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2025
- Study start30 Sep 2025
- Primary completion30 Sep 2028 (estimated)
- Study completion30 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Unilateral Spatial NeglectStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kettering Health Network
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rachelle M Janning, OTD, MS, OTR/L, Principal investigator, Kettering Health/Northern Kentucky University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07157865
- Sponsor's protocol ID
- KHN-2025-113
- Status last verified
- Mar 2026
- First submitted
- 28 Aug 2025
- Last updated
- 23 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: The research team will share age, sex, gender, and time since stroke of research subjects. Statistical analysis results summary including primary outcomes.
Publications
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.
PubMed 39930993Jacquin-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.
PubMed 23428624Fortis 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.
PubMed 30314612Eslami, 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
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.
PubMed 35673990Chen 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.
PubMed 34589681Chen, 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.
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.
PubMed 27181587
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of Prism Adaptation Training (PAT) Paired With Transcutaneous Electrical Stimulation (TENS) vs PAT Alone on Outcomes in Post-Stroke Patients Experiencing Unilateral Spatial Neglect (USN)
- ClinicalTrials.gov ID
- NCT07157865
- Acronym / sponsor ID
- KHN-2025-113
- Conditions
- Unilateral Spatial Neglect, Stroke
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Kettering Health NetworkUniversity, hospital or other
- Study start
- 30 Sep 2025 (actual)
- Primary completion
- 30 Sep 2028 (estimated)
- Study completion
- 30 Sep 2028 (estimated)
- First posted
- 5 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Unilateral spatial neglect (USN) is a common and disabling consequence of stroke, particularly following right-hemisphere lesions, affecting up to 50-70% of survivors. USN impairs a patient's ability to attend to or interact with stimuli on the side opposite the brain lesion, leading to significant challenges in daily functioning and rehabilitation engagement. The presence of USN is associated with poorer functional outcomes, increased dependence, and prolonged recovery after a stroke. Prism Adaptation Training (PAT) is a non-invasive intervention that has emerged as a promising approach for USN rehabilitation. PAT involves repeated visuomotor activities while wearing prism glasses that shift the visual field, promoting adaptation and recalibration of spatial attention. Multiple studies and systematic reviews have demonstrated that PAT can improve neglect symptoms, enhance motor control of the affected limb, and improve activities of daily living (ADL), with effects persisting for weeks to months post-intervention. However, the optimal dosing, duration, and potential for augmenting the effects of PAT remain areas of ongoing investigation. Transcutaneous Electrical Nerve Stimulation (TENS) is another non-invasive modality widely used in post-stroke rehabilitation. TENS delivers mild electrical currents through the skin to stimulate nerves and has shown efficacy in improving motor function, reducing spasticity, and enhancing functional recovery in stroke survivors. It has been shown to enhance upper limb function in individuals who have experienced a stroke. While TENS is primarily used for motor and sensory rehabilitation, its potential to modulate cortical excitability and facilitate neuroplasticity suggests it may also influence cognitive domains, including attention and spatial processing. There is evidence suggesting that TENS can have an impact on neglect. Despite the individual benefits of PAT and TENS in post-stroke rehabilitation, limited research has explored their combined effects on USN. The rationale for pairing PAT with TENS is based on the hypothesis that TENS-induced sensory stimulation may help enhance awareness of neglected space when applied to the upper extremity of individuals experiencing neglect, thereby potentially amplifying the adaptive effects of PAT on spatial neglect. However, the synergistic potential of TENS to enhance cognitive-perceptual rehabilitation strategies like PAT in the context of USN has not been systematically investigated. Given the persistent functional burden of USN and the need for more effective and accessible rehabilitation protocols, a pilot study comparing PAT paired with TENS versus PAT alone could provide critical preliminary evidence. Such research may identify whether adjunctive TENS can accelerate or enhance recovery from neglect, inform optimal intervention strategies, and ultimately improve independence and quality of life for stroke survivors experiencing USN.
The research question:
Is the combination of Prism Adaptation Therapy (PAT) and Transcutaneous Electrical Nerve Stimulation (TENS) more effective than PAT alone in reducing unilateral spatial neglect (USN) in individuals' post-stroke?
Hypothesis: The combination of Prism Adaptation Therapy (PAT) and Transcutaneous Electrical Nerve Stimulation (TENS) will be more effective than PAT alone in reducing unilateral spatial neglect (USN) in individuals post-stroke.
Primary study aim:
To evaluate whether the combination of Prism Adaptation Therapy (PAT) and Transcutaneous Electrical Nerve Stimulation (TENS) is more effective than PAT alone in reducing unilateral spatial neglect (USN) in individuals post-stroke.
Secondary study aims: To investigate whether patient characteristics (e.g. time since stroke, lesion location, severity of neglect, gender, age) influence the effectiveness of the combined intervention. To investigate the effects of the PAT alone and the combined PAT and TENS intervention on functional outcomes related to USN. To investigate the impact of PAT alone and the combined PAT and TENS intervention on the motor control of the neglected limb.
The main study outcome measures include:
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. All occupational therapists at the NeuroRehab and Balance Center (NRBC) have been trained in the proper administration and scoring of the CBS to ensure accurate results. It is standard protocol at NRBC clinic that all patients diagnosed with stroke are evaluated for potential USN using the CBS, which is routinely administered in these cases. In 2014, the Kessler Foundation published guidelines on how to administer the CBS.
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, helping to assess improvements in movement quality and reaction time following interventions. All occupational therapists at the NeuroRehab and Balance Center (NRBC) have received training in the administration and scoring of the WMFT, and it is standard protocol at NRBC that all patients diagnosed with stroke are evaluated using the WMFT.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PAT + TENS treatment | Experimental | Device: Prism adaptation training combined with TENSSubjects 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. |
| PAT only | Active comparator | Other: 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- A diagnosis of stroke
- Score 1 or above on the Catherine Bergego Scale
- Cognitively able to consent
Key exclusion criteria (6 listed)
- Seizure disorder
- Diagnosed with more than two strokes
- Diagnosis of schizophrenia or schizoaffective disorder
- Cancer diagnosis of upper extremity
- Individuals with pacemakers and debrillators
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Prism adaptation training combined with TENSSubjects 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. | Device | PAT + TENS treatment |
| PAT onlySubjects will receive prism adaptation training (PAT) only wearing prism goggles during a functional reaching task during occupational therapy. | Other | PAT only |
Primary outcome
Change in unilateral spatial neglect functional deficits
Time frame: From enrollment to discharge from therapy services which is typically 8-12 weeks
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.
Change in motor control deficits
Time frame: From time of enrollment to discharge from therapy services typically 8-12 weeks
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2026.
- Background: PubMed 39930993Song 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.
- Results publication: PubMed 23428624Jacquin-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.
- Results publication: PubMed 30314612Fortis 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.
- Results publicationEslami, 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
- Results publication: PubMed 35673990Chen 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.
- Results publication: PubMed 34589681Chen 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.
- Results publicationChen, 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.
- Results publication: PubMed 27181587Champod 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.
- Individual participant dataSharing planned: Yes. The research team will share age, sex, gender, and time since stroke of research subjects. Statistical analysis results summary including primary outcomes.
Related trials for Unilateral Spatial Neglect
Recruiting
Immersive Virtual Reality Treatment for Unilateral Spatial Neglect
Stroke, Unilateral Spatial Neglect
RecruitingObservational study
Peripersonal Space Representation in Upper Limb Segmental Exclusion
Segmental Exclusion Syndrome, Complex Regional Pain Syndrome (CRPS)
Not yet recruitingObservational study
Tridimensional Robotic Assessment of Neglect in Brain Injured Patients
Neglect, Brain Injured Patients
RecruitingObservational study
Evaluation of the Variation Over Time of Visuospatial Deficit in Patients With Parietal Lobe Glioma
Glioma, Parietal Lobe Glioma
Recruiting
Rehabilitation Methods for Unilateral Spatial Neglect in Stroke Patients
Unilateral Spatial Neglect (USN)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Michelle Pershing, PhD contact
Rachelle M Janning, OTD, MS, OTR/L principal investigator
Kettering Health/Northern Kentucky University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prism adaptation training combined with TENS and PAT only in people with Unilateral Spatial Neglect and Stroke, run by Kettering Health Network at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rachelle M Janning, OTD, MS, OTR/L (19372324443, rachelle.janning@ketteringhealth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07157865, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2026.