search
Back to results

Remediation of Spatial Neglect Trial (RESPONSE)

Primary Purpose

Stroke, Acquired Brain Injury, Hemispatial Neglect

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Computerized Plasticity-based Adaptive Cognitive Training
Commercially available computerized training
Sponsored by
Posit Science Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 18 years of age or older
  • Diagnosis of an acquired brain injury (which may be in the form of a stroke or brain tumor removal) and
  • Evidence of deficit on at least 2 out of 4 assessment measures of Spatial Neglect: Mesulam Cancelation task (ages 50 and younger > 0 omissions; 51-80 > 4 omissions), Dual task (>19% difference in accuracy for right - left target trials), Tone Counting task (< 94% total accuracy), or Landmark task (deviation from objective center as determined by the 95% confidence interval, with neglect indicated with 'Y' and no neglect with 'N' following completion of task).
  • Must be at least 3 months out from their most recent acquired brain injury, stroke, or brain tumor removal
  • Fluent English speakers
  • Adequate sensorimotor capacity to participate in the trial, including visual capacity adequate to read from a computer screen at a normal viewing distance, auditory capacity adequate to understand normal speech, and motor capacity adequate to control a computer mouse

Exclusion Criteria:

  • A conjunction of prior acquired brain injury and score >8 on Blessed Scale - Short Form
  • Diagnosis of severe depression (a score of >29 on Beck Depression Inventory (BDI-II)
  • Diagnosis of chronic psychiatric disorders with associated cognitive impairments, eg. Schizophrenia
  • Diagnosis of illness, condition or treatment with known cognitive consequences, eg. chemotherapy
  • Active Suicidal Ideation with Specific Plan and Intent or any suicide-related behaviors within 2 months of consent
  • A current or significant past history of substance abuse
  • Difficulty completing assessments and/or comprehending requirements of trial
  • Enrollment in a concurrent clinical trial involving an investigational pharmaceutical, nutraceutical, medical device or behavioral treatment that could affect the outcome of this study
  • Complete primary visual field deficit, score of 3 on NIH Stroke Scale - Visual Field Subscale

Sites / Locations

  • Washington University School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Experimental Treatment

Active Comparator

Arm Description

Computerized Plasticity-based Adaptive Cognitive Training requiring a total maximum of 39 treatment sessions, 4-5 times weekly, ~30 mins each session.

Commercially available computerized training requiring a total maximum of 39 treatment sessions, 4-5 times weekly, ~30 mins each session.

Outcomes

Primary Outcome Measures

Performance on Posner Cueing Task
Between-group magnitude of change in reaction time (RT) for RT detecting targets appearing on the left side of the display minus the RT for detecting targets appearing on the right side of the display as measured by Posner Cueing Task. Positive reaction time difference scores indicate a rightward bias; whereas, negative reaction time difference scores indicate a leftward bias in spatial attention.

Secondary Outcome Measures

Change in Spatial Cognition (Multiple scores are aggregated to arrive at a single composite score)
Between-group magnitude of change in composite score with the measure constructed from Greyscales Task (perceptual bias score) and Spatial Working Memory Task (percent accuracy for targets). The composite is composed of the individual measures combined as follows: i. For each included variable convert the distribution of raw scores in the Intent-to-Treat population at baseline to z-scores (with a mean of 0 and a standard deviation of 1). ii. Compute the average of all z-scores to create a single score for the composite measure.
Change in Cognitive Performance (Multiple scores are aggregated to arrive at a single composite score)
Between-group magnitude of change in composite score with the measure constructed from Delis-Kaplan Executive Function System Verbal Fluency (Letter Fluency, raw scores; Category Fluency total, raw scores; Category Switching total, raw scores; Category Switching, switching Accuracy total, raw scores), Wechsler Adult Intelligence Scale (WAIS-IV) Digit Span total (sum of forward, backward, sequencing raw scores), WAIS-IV Digit Span (Forward total, raw scores; Backward total, raw scores; Sequencing total, raw scores), and Gradual Continuous Performance Task (percent accuracy for targets and standard deviation (SD) of average reaction time for non-targets). The composite is composed of the individual measures combined as follows: i. For each included variable convert the distribution of raw scores in the Intent-to-Treat population at baseline to z-scores (with a mean of 0 and a SD of 1). ii. Compute the average of all z-scores to create a single score for the composite measure.
Change in Functional Ability (Multiple scores are aggregated to arrive at a single composite score)
Between-group magnitude of change in composite score with the measure constructed from Catherine Bergego Scale total (raw score) and Barthel Index total (raw score). The composite is composed of the individual measures combined as follows: i. For each included variable convert the distribution of raw scores in the Intent-to-Treat population at baseline to z-scores (with a mean of 0 and a standard deviation of 1). ii. Compute the average of all z-scores to create a single score for the composite measure.
Change in Quality of Life (Multiple scores are aggregated to arrive at a single composite score)
Between-group magnitude of change in composite score with the measure constructed from SF-12v2 Health Survey Physical and Mental Component Scores. The composite is composed of the individual measures combined as follows: i. For each included variable convert the distribution of raw scores in the Intent-to-Treat population at baseline to z-scores (with a mean of 0 and a standard deviation of 1). ii. Compute the average of all z-scores to create a single score for the composite measure.
Change in Quality of Sleep: Pittsburgh Sleep Quality Index (Multiple scores are aggregated to arrive at a single composite score)
Between-group magnitude of change in composite score with the measure constructed from Pittsburgh Sleep Quality Index (PSQI, sum of component scores), PSQI Sleep Efficiency (raw score), and PSQI Component scores. The composite is composed of the individual measures combined as follows: i. For each included variable convert the distribution of raw scores in the Intent-to-Treat population at baseline to z-scores (with a mean of 0 and a standard deviation of 1). ii. Compute the average of all z-scores to create a single score for the composite measure.
Performance on Posner Cueing Task
Between-group magnitude of change in reaction time (RT) for RT detecting targets appearing on the left side of the display minus the RT for detecting targets appearing on the right side of the display as measured by Posner Cueing Task. Positive reaction time difference scores indicate a rightward bias; whereas, negative reaction time difference scores indicate a leftward bias in spatial attention.

Full Information

First Posted
October 16, 2013
Last Updated
July 2, 2020
Sponsor
Posit Science Corporation
Collaborators
Washington University School of Medicine, VA Boston Healthcare System, Spaulding Rehabilitation Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT01965951
Brief Title
Remediation of Spatial Neglect Trial
Acronym
RESPONSE
Official Title
RESPONSE: Remediation of Spatial Neglect Trial
Study Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
July 2013 (undefined)
Primary Completion Date
March 2017 (Actual)
Study Completion Date
March 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Posit Science Corporation
Collaborators
Washington University School of Medicine, VA Boston Healthcare System, Spaulding Rehabilitation Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Problems with attention are a common and debilitating consequence of brain injury. Studies show that poor attention is the number one predictor of poor cognitive functioning one year post-injury. This is due to the fact that attention is a necessary component of more complex cognitive functions such as learning & memory, multi-tasking and problem solving. In many cases, individuals may exhibit problems with spatial attention known as 'hemi-spatial neglect syndrome' or simply 'neglect'. Many studies now show that the processing machinery of the brain is plastic and remodeled throughout life by learning and experience, enabling the strengthening of cognitive skills or abilities. Research has shown that brief, daily computerized cognitive training that is sufficiently challenging, goal-directed and adaptive enables intact brain structures to restore balance in attention and compensate for disruptions in cognitive functioning. The study aims to understand how our computer program can affect cognition and attention in those with acquired brain injury.
Detailed Description
Following consent, participants will engage in an assessment process to determine eligibility. Once eligibility is confirmed, participants will be scheduled for another assessment session to determine current level of cognitive function. This process consists of paper-pencil surveys and computerized tests. Following the assessment process, participants will engage in an Internet browser-delivered training sessions conducted on any internet-accessible computer. The computerized training sessions can be done up to 7 times a week (once a day) or at participant's convenience (we recommend 5 times a week). Following the completion of training, the participant's cognitive function will be re-assessed and again after 3-month no-contact period. Participation is voluntary and participants may withdraw from the study at any time.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Acquired Brain Injury, Hemispatial Neglect

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
96 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental Treatment
Arm Type
Experimental
Arm Description
Computerized Plasticity-based Adaptive Cognitive Training requiring a total maximum of 39 treatment sessions, 4-5 times weekly, ~30 mins each session.
Arm Title
Active Comparator
Arm Type
Active Comparator
Arm Description
Commercially available computerized training requiring a total maximum of 39 treatment sessions, 4-5 times weekly, ~30 mins each session.
Intervention Type
Other
Intervention Name(s)
Computerized Plasticity-based Adaptive Cognitive Training
Intervention Description
Computerized Plasticity-based Adaptive Cognitive Training requiring a total maximum of 39 treatment sessions, 4-5 times weekly, ~30 mins each session.
Intervention Type
Other
Intervention Name(s)
Commercially available computerized training
Intervention Description
Commercially available computerized training requiring a total maximum of 39 treatment sessions, 4-5 times weekly, ~30 mins each session.
Primary Outcome Measure Information:
Title
Performance on Posner Cueing Task
Description
Between-group magnitude of change in reaction time (RT) for RT detecting targets appearing on the left side of the display minus the RT for detecting targets appearing on the right side of the display as measured by Posner Cueing Task. Positive reaction time difference scores indicate a rightward bias; whereas, negative reaction time difference scores indicate a leftward bias in spatial attention.
Time Frame
At 3 months
Secondary Outcome Measure Information:
Title
Change in Spatial Cognition (Multiple scores are aggregated to arrive at a single composite score)
Description
Between-group magnitude of change in composite score with the measure constructed from Greyscales Task (perceptual bias score) and Spatial Working Memory Task (percent accuracy for targets). The composite is composed of the individual measures combined as follows: i. For each included variable convert the distribution of raw scores in the Intent-to-Treat population at baseline to z-scores (with a mean of 0 and a standard deviation of 1). ii. Compute the average of all z-scores to create a single score for the composite measure.
Time Frame
At 3 months and at 6 months
Title
Change in Cognitive Performance (Multiple scores are aggregated to arrive at a single composite score)
Description
Between-group magnitude of change in composite score with the measure constructed from Delis-Kaplan Executive Function System Verbal Fluency (Letter Fluency, raw scores; Category Fluency total, raw scores; Category Switching total, raw scores; Category Switching, switching Accuracy total, raw scores), Wechsler Adult Intelligence Scale (WAIS-IV) Digit Span total (sum of forward, backward, sequencing raw scores), WAIS-IV Digit Span (Forward total, raw scores; Backward total, raw scores; Sequencing total, raw scores), and Gradual Continuous Performance Task (percent accuracy for targets and standard deviation (SD) of average reaction time for non-targets). The composite is composed of the individual measures combined as follows: i. For each included variable convert the distribution of raw scores in the Intent-to-Treat population at baseline to z-scores (with a mean of 0 and a SD of 1). ii. Compute the average of all z-scores to create a single score for the composite measure.
Time Frame
At 3 months and at 6 months
Title
Change in Functional Ability (Multiple scores are aggregated to arrive at a single composite score)
Description
Between-group magnitude of change in composite score with the measure constructed from Catherine Bergego Scale total (raw score) and Barthel Index total (raw score). The composite is composed of the individual measures combined as follows: i. For each included variable convert the distribution of raw scores in the Intent-to-Treat population at baseline to z-scores (with a mean of 0 and a standard deviation of 1). ii. Compute the average of all z-scores to create a single score for the composite measure.
Time Frame
At 3 months and at 6 months
Title
Change in Quality of Life (Multiple scores are aggregated to arrive at a single composite score)
Description
Between-group magnitude of change in composite score with the measure constructed from SF-12v2 Health Survey Physical and Mental Component Scores. The composite is composed of the individual measures combined as follows: i. For each included variable convert the distribution of raw scores in the Intent-to-Treat population at baseline to z-scores (with a mean of 0 and a standard deviation of 1). ii. Compute the average of all z-scores to create a single score for the composite measure.
Time Frame
At 3 months and at 6 months
Title
Change in Quality of Sleep: Pittsburgh Sleep Quality Index (Multiple scores are aggregated to arrive at a single composite score)
Description
Between-group magnitude of change in composite score with the measure constructed from Pittsburgh Sleep Quality Index (PSQI, sum of component scores), PSQI Sleep Efficiency (raw score), and PSQI Component scores. The composite is composed of the individual measures combined as follows: i. For each included variable convert the distribution of raw scores in the Intent-to-Treat population at baseline to z-scores (with a mean of 0 and a standard deviation of 1). ii. Compute the average of all z-scores to create a single score for the composite measure.
Time Frame
At 3 months and at 6 months
Title
Performance on Posner Cueing Task
Description
Between-group magnitude of change in reaction time (RT) for RT detecting targets appearing on the left side of the display minus the RT for detecting targets appearing on the right side of the display as measured by Posner Cueing Task. Positive reaction time difference scores indicate a rightward bias; whereas, negative reaction time difference scores indicate a leftward bias in spatial attention.
Time Frame
At 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 18 years of age or older Diagnosis of an acquired brain injury (which may be in the form of a stroke or brain tumor removal) and Evidence of deficit on at least 2 out of 4 assessment measures of Spatial Neglect: Mesulam Cancelation task (ages 50 and younger > 0 omissions; 51-80 > 4 omissions), Dual task (>19% difference in accuracy for right - left target trials), Tone Counting task (< 94% total accuracy), or Landmark task (deviation from objective center as determined by the 95% confidence interval, with neglect indicated with 'Y' and no neglect with 'N' following completion of task). Must be at least 3 months out from their most recent acquired brain injury, stroke, or brain tumor removal Fluent English speakers Adequate sensorimotor capacity to participate in the trial, including visual capacity adequate to read from a computer screen at a normal viewing distance, auditory capacity adequate to understand normal speech, and motor capacity adequate to control a computer mouse Exclusion Criteria: A conjunction of prior acquired brain injury and score >8 on Blessed Scale - Short Form Diagnosis of severe depression (a score of >29 on Beck Depression Inventory (BDI-II) Diagnosis of chronic psychiatric disorders with associated cognitive impairments, eg. Schizophrenia Diagnosis of illness, condition or treatment with known cognitive consequences, eg. chemotherapy Active Suicidal Ideation with Specific Plan and Intent or any suicide-related behaviors within 2 months of consent A current or significant past history of substance abuse Difficulty completing assessments and/or comprehending requirements of trial Enrollment in a concurrent clinical trial involving an investigational pharmaceutical, nutraceutical, medical device or behavioral treatment that could affect the outcome of this study Complete primary visual field deficit, score of 3 on NIH Stroke Scale - Visual Field Subscale
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas Van Vleet, PhD
Organizational Affiliation
Posit Science Corporation
Official's Role
Principal Investigator
Facility Information:
Facility Name
Washington University School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
9556766
Citation
Friedrich FJ, Egly R, Rafal RD, Beck D. Spatial attention deficits in humans: a comparison of superior parietal and temporal-parietal junction lesions. Neuropsychology. 1998 Apr;12(2):193-207. doi: 10.1037//0894-4105.12.2.193.
Results Reference
background
PubMed Identifier
8892067
Citation
Husain M, Kennard C. Visual neglect associated with frontal lobe infarction. J Neurol. 1996 Sep;243(9):652-7. doi: 10.1007/BF00878662.
Results Reference
background
PubMed Identifier
8137006
Citation
Heilman KM, Bowers D, Valenstein E, Watson RT. Disorders of visual attention. Baillieres Clin Neurol. 1993 Aug;2(2):389-413. No abstract available.
Results Reference
background
PubMed Identifier
12821519
Citation
Mort DJ, Malhotra P, Mannan SK, Rorden C, Pambakian A, Kennard C, Husain M. The anatomy of visual neglect. Brain. 2003 Sep;126(Pt 9):1986-97. doi: 10.1093/brain/awg200. Epub 2003 Jun 23.
Results Reference
background
PubMed Identifier
6737043
Citation
Posner MI, Walker JA, Friedrich FJ, Rafal RD. Effects of parietal injury on covert orienting of attention. J Neurosci. 1984 Jul;4(7):1863-74. doi: 10.1523/JNEUROSCI.04-07-01863.1984.
Results Reference
background
PubMed Identifier
24502769
Citation
Vleet TV, DeGutis J, Dabit S, Chiu C. Randomized control trial of computer-based rehabilitation of spatial neglect syndrome: the RESPONSE trial protocol. BMC Neurol. 2014 Feb 7;14:25. doi: 10.1186/1471-2377-14-25.
Results Reference
derived

Learn more about this trial

Remediation of Spatial Neglect Trial

We'll reach out to this number within 24 hrs