Remediation of Spatial Neglect Trial

NCT01965951 | Completed DMC

• 1 other identifier: PSC-1004-13
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke; Acquired Brain Injury; Hemispatial Neglect

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Change in Spatial Cognition (Multiple scores are aggregated to arrive at a single composite score)

  At 3 months and at 6 months

• Change in Cognitive Performance (Multiple scores are aggregated to arrive at a single composite score)

  At 3 months and at 6 months

• Change in Functional Ability (Multiple scores are aggregated to arrive at a single composite score)

  At 3 months and at 6 months

• Change in Quality of Life (Multiple scores are aggregated to arrive at a single composite score)

  At 3 months and at 6 months

• Change in Quality of Sleep: Pittsburgh Sleep Quality Index (Multiple scores are aggregated to arrive at a single composite score)

  At 3 months and at 6 months

Study Arms (2)

Experimental Treatment

EXPERIMENTAL

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

Other: Computerized Plasticity-based Adaptive Cognitive Training

Active Comparator

ACTIVE COMPARATOR

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

Other: Commercially available computerized training

Interventions

Computerized Plasticity-based Adaptive Cognitive Training OTHER

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

Experimental Treatment

Commercially available computerized training OTHER

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

Active Comparator

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Posit Science Corporation: lead
• Washington University School of Medicine: collaborator
• VA Boston Healthcare System: collaborator
• Spaulding Rehabilitation Hospital: collaborator

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Related Publications (6)

• 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.

  PMID: 9556766 BACKGROUND

• Husain M, Kennard C. Visual neglect associated with frontal lobe infarction. J Neurol. 1996 Sep;243(9):652-7. doi: 10.1007/BF00878662.

  PMID: 8892067 BACKGROUND

• Heilman KM, Bowers D, Valenstein E, Watson RT. Disorders of visual attention. Baillieres Clin Neurol. 1993 Aug;2(2):389-413. No abstract available.

  PMID: 8137006 BACKGROUND

• 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.

  PMID: 12821519 BACKGROUND

• 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.

  PMID: 6737043 BACKGROUND

• 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.

  PMID: 24502769 DERIVED

MeSH Terms

Conditions

Stroke; Brain Injuries; Perceptual Disorders

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Neurobehavioral Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Thomas Van Vleet, PhD

  Posit Science Corporation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 16, 2013
• First Posted: October 18, 2013
• Study Start: July 1, 2013
• Primary Completion: March 1, 2017
• Study Completion: March 1, 2017
• Last Updated: July 7, 2020

Record last verified: 2020-07

Locations

US (1)