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Prism Adaptation in Left Brain Stroke

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04387162
Recruitment Status : Not yet recruiting
First Posted : May 13, 2020
Last Update Posted : May 13, 2020
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

Brief Summary:
Of the 15,000 Veterans who are hospitalized for stroke each year more than half experience spatial and motor impairments and pain. Spatial-motor-sensory problems limit functioning and independence, which is costly to Veterans, their families, and society. Currently, spatial-motor-sensory problems are targeted using different treatments. However, there is a treatment that has shown promise in simultaneously targeting spatial function, motor function and pain in right-brain stroke. The investigators propose to investigate the feasibility of using adapted spatial-motor sensory assessment and treatment procedures for Veterans with left-brain stroke who have language and cognitive impairment. The next step will be to conduct a large-scale study focused on this multi-target treatment for more efficient and effective stroke rehabilitation. The investigators expect this line of research to increase functioning, independence and quality of life in Veteran stroke survivors.

Condition or disease Intervention/treatment Phase
Aphasia Spatial Neglect Stroke Behavioral: Prism Adaptation Treatment Not Applicable

Detailed Description:

The functional disability experienced by Veterans after stroke, and the limited rehabilitation resources available, highlight the importance of identifying feasible treatments acting on more than one recovery target. Currently, there are separate and modality-specific treatment pathways for cognitive and motor impairments. These modality-specific treatment pathways lead to fragmentation of care, and under-identification and under-treatment of invisible disabilities, such as spatial neglect, aphasia and pain. The result is longer hospital stays, greater risk of falls, and poor functional outcomes. Employing a treatment that simultaneously addresses multiple targets will ensure that the investigators provide the needed care for >50% of post-stroke Veterans who have both visible and invisible disabilities, during the critical post-acute period of recovery.

Prism adaptation treatment (PAT) is a 10-day regimen reported to be inexpensive, replicable and effective for treatment of spatial neglect, and studies have demonstrated that it also enhances everyday activities and motor recovery and reduces chronic post-stroke pain in patients with right brain stroke. Additionally, brain mapping methods have shown that in patients with right brain stroke, those with frontal lesions respond optimally to PAT. No studies have investigated PAT in left-brain stroke patients with language and cognitive impairment. To address this research gap, the investigators will address the following aims:

Aim 1: To demonstrate the feasibility of adapted PAT procedures in patients with aphasia and memory impairment. .

Aim 2: To demonstrate the feasibility of adapted methods for assessing spatial and motor function and pain in patients with aphasia and memory impairment.

Aim 3: To demonstrate the feasibility of using information about lesion location from the radiology report to classify frontal vs. nonfrontal lesions.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Multiple baseline, delayed treatment design
Masking: Single (Outcomes Assessor)
Masking Description: Neurologist will conduct blinded classification of "frontal" or "nonfrontal" lesions
Primary Purpose: Treatment
Official Title: One Treatment, Multiple Targets: Prism Adaptation and Left Brain Stroke Rehabilitation
Estimated Study Start Date : July 1, 2020
Estimated Primary Completion Date : June 15, 2022
Estimated Study Completion Date : June 30, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Immediate
Participants will enter treatment after one week baseline
Behavioral: Prism Adaptation Treatment
Spatial retraining treatment

Experimental: Delayed
Participants will enter treatment after two week baseline
Behavioral: Prism Adaptation Treatment
Spatial retraining treatment




Primary Outcome Measures :
  1. Client Satisfaction Questionnaire [ Time Frame: Immediately following the two-week treatment (study week 3 in immediate group, study week 5 in delayed group) ]
    Assessment of satisfaction and perceived value of Prism Adaptation Treatment; scores range from 8-32, with higher scores indicating greater satisfaction

  2. Credibility/Expectancy Questionnaire [ Time Frame: Immediately following the two-week treatment (study week 3 in immediate group, study week 5 in delayed group) ]
    Assessment of whether Prism Adaptation Treatment is believable, convincing and logical (credibility) and the expectations for treatment-induced improvement (expectancy); two rating scales with one scale ranging from 1-9 and from 0%-100%, with higher scores indicating greater credibility and expectancy.

  3. Barthel Index [ Time Frame: Weekly from baseline to follow-up (study week 7); CHANGE from baseline to immediate post-treatment (study week 3 in immediate group, study week 5 in delayed group), CHANGE from baseline to two weeks post-treatment (study week 7) ]
    Assessment of functional disability by activities of daily living; scores range from 0-100, with higher score indicating greater independence and less functional disability

  4. Functional Independence Measure [ Time Frame: Weekly from baseline to follow-up (study week 7); CHANGE from baseline to immediate post-treatment (study week 3 in immediate group, study week 5 in delayed group), CHANGE from baseline to two weeks post-treatment (study week 7) ]
    Assessment of cognitive and motor function; scores range from 18-126, with a higher score indicating greater functional independence

  5. Behavioral Inattention Test- Conventional Subtest [ Time Frame: Weekly from baseline to follow-up (study week 7); CHANGE from baseline to immediate post-treatment (study week 3 in immediate group, study week 5 in delayed group), CHANGE from baseline to two weeks post-treatment (study week 7) ]
    Assessment of spatial neglect; severity scores range from 1-6, with higher scores indicating more severe spatial neglect

  6. Catherine Bergego Scale via the Kessler Foundation Neglect Assessment Process [ Time Frame: Weekly from baseline to follow-up (study week 7); CHANGE from baseline to immediate post-treatment (study week 3 in immediate group, study week 5 in delayed group), CHANGE from baseline to two weeks post-treatment (study week 7) ]
    Assessment of spatial neglect; scores range from 0-30, with higher scores indicating more severe spatial neglect

  7. Wolf Motor Function Test [ Time Frame: Weekly from baseline to follow-up (study week 7); CHANGE from baseline to immediate post-treatment (study week 3 in immediate group, study week 5 in delayed group), CHANGE from baseline to two weeks post-treatment (study week 7) ]
    Assessment of motor function; scores range from 0-75, with higher scores indicating less impairment in motor function

  8. Defense and Veterans Pain Rating Scale [ Time Frame: Weekly from baseline to follow-up (study week 7); CHANGE from baseline to immediate post-treatment (study week 3 in immediate group, study week 5 in delayed group), CHANGE from baseline to two weeks post-treatment (study week 7) ]
    Assessment of pain; scores range from 0-10, with higher scores indicating more severe pain

  9. Classification of lesion location [ Time Frame: Baseline ]
    Assessment of whether lesion is "frontal" or "nonfrontal"



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 89 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 1-3 months post-stroke, entering outpatient treatment
  • proficient English speakers
  • experiencing moderate functional disability as measured by Functional Independence Measure (FIM), observational or telephone-administered FONE-FIM
  • experiencing aphasia as determined by a Western Aphasia Battery Aphasia Quotient and memory impairment as determined by the Brief Visuospatial Memory Test- Revised, the Hopkins Verbal Learning Test- Revised or digit span forward and backward
  • able to provide informed consent to participate, using aphasia-accessible process, as needed.

Exclusion Criteria:

  • History of brain conditions other than left brain stroke, including clinical right brain pathology.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04387162


Contacts
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Contact: Amy D Rodriguez, PhD (404) 321-6111 ext 204201 amy.rodriguez@va.gov
Contact: Laura Britan Lang, MPH (404) 321-6111 ext 7027 Laura.Britan_Lang@va.gov

Locations
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United States, Georgia
Atlanta VA Medical and Rehab Center, Decatur, GA
Decatur, Georgia, United States, 30033
Contact: Amy D Rodriguez, PhD    404-321-6111 ext 204201    amy.rodriguez@va.gov   
Principal Investigator: Amy D. Rodriguez, PhD         
Sponsors and Collaborators
VA Office of Research and Development
Investigators
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Principal Investigator: Amy D. Rodriguez, PhD Atlanta VA Medical and Rehab Center, Decatur, GA
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Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT04387162    
Other Study ID Numbers: B3474-P
RX003474-01 ( Other Grant/Funding Number: VAORD )
First Posted: May 13, 2020    Key Record Dates
Last Update Posted: May 13, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by VA Office of Research and Development:
aphasia
spatial neglect
rehabilitation
Additional relevant MeSH terms:
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Stroke
Aphasia
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Speech Disorders
Language Disorders
Communication Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Signs and Symptoms