Broad-spectrum Cognitive Remediation: Effects of a Brain Plasticity-based Program in Mild Traumatic Brain Injury

NCT01640158 | Completed DMC

• 1 other identifier: BPI-1002-11
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective of this study is to evaluate the effects of plasticity-based, adaptive cognitive remediation on the cognitive abilities, functional status and quality of life of soldiers and veterans diagnosed with persistent post-concussive symptoms (PPCS) following a mild traumatic brain injury (mTBI, also referred to as a concussion, or blast exposure), as compared to a computer-based control.

Conditions

Traumatic Brain Injury

Keywords

mild Traumatic Brain Injury; Cognitive remediation; computer

Outcome Measures

Primary Outcomes (2)

• Change in Cognitive Function

  Between-group magnitude of change in composite score with the measure constructed from Rey Auditory Verbal Learning Test (RAVLT) sum of trials 1-5 (immediate verbal memory), RAVLT delayed verbal recall, the Ruff Light Trails Test (RULIT) sum of trials 2-10 (immediate visual memory), RULIT delayed recall scores, digit span (WAIS, sum of forwards, backwards, sequencing), symbol span (WMS), anti-saccades, flanker, and set-shifting (each from the EXAMINER battery).

  After three months of training

• Change in Functional Performance

  Between-group magnitude of change in sum time of all tasks in the Timed Instrumental Activities of Daily Living (TIADL). Higher scores indicate greater impairment in functional performance.

  After three months of training

Secondary Outcomes (18)

• Change in Mental Health-Related Quality of Life

  After three months of training and 3 months after training completion

• Change in Physical Health-Related Quality of Life

  After three months of training and 3 months after training completion

• Change in Depressive Symptoms

  After three months of training and 3 months after training completion

• Change in PTSD Symptoms

  After three months of training and 3 months after training completion

• Change in Executive Function Symptoms

  After three months of training and 3 months after training completion

Study Arms (2)

Experimental Treatment

EXPERIMENTAL

Computerized plasticity-based adaptive cognitive training, up to 65 hours

Other: Computerized Plasticity-based Adaptive Cognitive Training

Active Comparator

ACTIVE COMPARATOR

Commercially available computerized training, up to 65 hours

Other: Commercially available computerized training

Interventions

Computerized Plasticity-based Adaptive Cognitive Training OTHER

Computerized plasticity-based adaptive cognitive training, up to 65 hours

Experimental Treatment

Commercially available computerized training OTHER

Commercially available computerized training, up to 65 hours

Active Comparator

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Subjects must be 18 - 50 years of age at the time of consent
• Subjects must have a diagnosis of mTBI
• Subjects must have persistent cognitive dysfunction confirmed by an objective measure (as recommended by the ICD-10 definition for post-concussion syndrome) or a subjective measure (as recommended by the DSV-IV definition of post-concussional disorder).
• Subjects must be at least three months out from their most recent TBI, concussion, and/or blast exposure to minimize the effects of spontaneous recovery, as verified through participant interview.
• Subjects must be fluent English speakers.
• Subjects must have adequate sensorimotor capacity to perform the program in the judgment of the consenting clinician.

You may not qualify if:

• Subjects must not have a history of penetrating head wounds or a diagnosis of moderate or severe TBI.
• Subjects must not be in-patients.
• Subjects must not have a diagnosis of an illness or condition with known cognitive consequences (e.g., schizophrenia, bipolar disorder, cancer, multiple sclerosis).
• Subjects must not show suicidal ideation as measured by the Columbia-Suicide Severity Rating Scale (C-SSRS).
• Subjects must now show signs of intoxication due to current substance abuse (including alcohol and/or illegal drugs) during any in person visit.
• Subjects must not have clinically significant visual field deficits noted by the consenting staff member by direct observation or by medical history.
• Subjects must not be judged to be lacking effort.
• Subjects must not have problems performing assessments or comprehending or following spoken instructions.
• Subjects must not be enrolled in a concurrent clinical trial involving an investigational pharmaceutical, nutraceutical, medical device, or behavioral treatment for TBI that could affect the outcome of this study.

Sponsors & Collaborators

• Posit Science Corporation: lead
• Congressionally Directed Medical Research Programs: collaborator
• Walter Reed National Military Medical Center: collaborator
• Tripler Army Medical Center: collaborator
• VA Connecticut Healthcare System: collaborator
• VA Boston Healthcare System: collaborator
• Michael E. DeBakey VA Medical Center: collaborator

Study Sites (1)

Posit Science Corporation

San Francisco, California, 94108, United States

Location

Related Publications (1)

• Consensus conference. Rehabilitation of persons with traumatic brain injury. NIH Consensus Development Panel on Rehabilitation of Persons With Traumatic Brain Injury. JAMA. 1999 Sep 8;282(10):974-83.

  PMID: 10485684 BACKGROUND

MeSH Terms

Conditions

Brain Injuries, Traumatic; Brain Concussion

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Head Injuries, Closed; Wounds, Nonpenetrating

Study Officials

• Henry W Mahncke, PhD

  Posit Science Corporation

  PRINCIPAL INVESTIGATOR

• Cate N Stasio, BA

  Posit Science Corporation

  STUDY DIRECTOR

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: July 10, 2012
• First Posted: July 13, 2012
• Study Start: September 1, 2013
• Primary Completion: March 2, 2017
• Study Completion: March 2, 2017
• Last Updated: April 16, 2019

Record last verified: 2019-04

Locations

US (1)