Remediation of Spatial Neglect Trial

Stroke Clinical Trial

— RESPONSE  

Official title:

RESPONSE: Remediation of Spatial Neglect Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01965951
• Other study ID #: PSC-1004-13
• Status: Completed
• Phase: N/A
• Start date: July 2013
• Est. completion date: March 2017

Study information

• Verified date: July 2020
• Source: Posit Science Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 96
• Est. completion date: March 2017
• Est. primary completion date: March 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acquired Brain Injury
• Brain Injuries
• Hemispatial Neglect
• Perceptual Disorders
• Stroke

Intervention

Other:
• Computerized Plasticity-based Adaptive Cognitive Training
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
Commercially available computerized training requiring a total maximum of 39 treatment sessions, 4-5 times weekly, ~30 mins each session.

Locations

Country	Name	City	State
United States	Washington University School of Medicine	Saint Louis	Missouri

Sponsors (4)

Lead Sponsor	Collaborator
Posit Science Corporation	Spaulding Rehabilitation Hospital, VA Boston Healthcare System, Washington University School of Medicine

Country where clinical trial is conducted

United States, 

References & Publications (5)

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. — View Citation

Heilman KM, Bowers D, Valenstein E, Watson RT. Disorders of visual attention. Baillieres Clin Neurol. 1993 Aug;2(2):389-413. Review. — View Citation

Husain M, Kennard C. Visual neglect associated with frontal lobe infarction. J Neurol. 1996 Sep;243(9):652-7. — View 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. Epub 2003 Jun 23. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	At 3 months
Secondary	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.	At 3 months and at 6 months
Secondary	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.	At 3 months and at 6 months
Secondary	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.	At 3 months and at 6 months
Secondary	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.	At 3 months and at 6 months
Secondary	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.	At 3 months and at 6 months
Secondary	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.	At 6 months