Clinical trial NCT01965951: Remediation of Spatial Neglect Trial
Official title: RESPONSE: Remediation of Spatial Neglect Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Acquired Brain Injury
Hemispatial Neglect
Lead sponsor: Posit Science Corporation
Sponsor class: INDUSTRY
Collaborators: name: Washington University School of Medicine
name: VA Boston Healthcare System
name: Spaulding Rehabilitation Hospital
First posted: 2013-10-18
Enrollment: 96
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Performance on Posner Cueing Task
timeFrame: At 3 months
Secondary outcomes:
measure: Change in Spatial Cognition (Multiple scores are aggregated to arrive at a single composite score)
timeFrame: At 3 months and at 6 months
measure: Change in Cognitive Performance (Multiple scores are aggregated to arrive at a single composite score)
timeFrame: At 3 months and at 6 months
measure: Change in Functional Ability (Multiple scores are aggregated to arrive at a single composite score)
timeFrame: At 3 months and at 6 months
measure: Change in Quality of Life (Multiple scores are aggregated to arrive at a single composite score)
timeFrame: At 3 months and at 6 months
measure: Change in Quality of Sleep: Pittsburgh Sleep Quality Index (Multiple scores are aggregated to arrive at a single composite score)
timeFrame: At 3 months and at 6 months
measure: Performance on Posner Cueing Task
timeFrame: At 6 months
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
Study officials:
affiliation: Posit Science Corporation
name: Thomas Van Vleet, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
citation: Husain M, Kennard C. Visual neglect associated with frontal lobe infarction. J Neurol. 1996 Sep;243(9):652-7. doi: 10.1007/BF00878662.
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.
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.
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.
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.