- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01339806
The Study of Cognitive Rehabilitation Effectiveness for Mild Traumatic Brain Injury (SCORE)
Phase IV Study of Cognitive Rehabilitation Effectiveness for Mild Traumatic Brain Injury
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This is a prospective, randomized, control treatment trial of cognitive rehabilitation for OEF/OIF Service Members with a history of mild traumatic brain injury (mTBI) and persistent (3-24 months post-injury) cognitive complaints. Subjects will be recruited from consecutive patient referrals to the TBI Service at SAMMC-North. Patients who meet eligibility criteria and consent to participate in the treatment trial will be randomly assigned to one of four, 6-week treatment arms of the study: 1. Psychoeducational control group; 2. Non-therapist directed, computerized cognitive rehabilitation; 3. Therapist-directed individualized cognitive rehabilitation; and 4. Integrated interdisciplinary cognitive rehabilitation combined with cognitive-behavioral psychotherapy. (Components of the treatment arms are described in detail in section 4.6; Research Design and Methods.) All subjects enrolled in the study will receive the standard of care in management of chronic post-concussive symptoms, consistent with the VA/DoD Clinical Practice Guidelines for the Management of Concussion/mild TBI (Barth et al., 2009), regardless of treatment assignment. The standard of care includes provision of patient education materials (adapted from existing studies to address more persistent rather than acute symptom management), regular scheduled follow-up with a medical provider every three weeks, and symptom-based treatment of post-concussive complaints (e.g., medication trials for headache and co-occurring psychiatric disorders, physical therapy for vestibular complaints, case management, and supportive counseling with social work for soldiers assigned to the Warriors-in-Transition Battalion). Study participants who are assigned to treatment arms 2, 3, or 4 will additionally receive manualized cognitive rehabilitation therapies during the 6-week treatment phase of the study. Cognitive rehabilitation treatment intensity (i.e., number of hours of treatment per week) will be matched for individuals assigned to treatment arms 2, 3, or 4. Participants assigned to the control treatment group (treatment arm 1) will be offered individualized cognitive rehabilitation therapy if their cognitive complaints do not abate following the completion of the six-week treatment trial.
Study participants will be evaluated prior to the initiation of treatment, as well as at 3-weeks, 6-weeks, 12-weeks, and 18-weeks following the start of treatment. Study evaluators will be blind to treatment assignment. Pre-treatment baseline assessments and peri-/post-treatment outcome assessments will include demographic information, injury-related variables, self-report inventories, performance on neuropsychological testing, and functional status (e.g., work status; healthcare utilization). Detailed descriptions of the data to be collected including primary and secondary outcome measures, as well as co-variate measures can be found in section 4.8: Instrumentation.
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
Texas
-
San Antonio, Texas, United States, 78234
- Brooke Army Medical Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Diagnosis of mTBI as defined in the VA/DoD Clinical Practice Guidelines for the Management of Concussion/mild TBI (Barth et al., 2009) which occurred during deployment in support of OEF/OIF within 3-24 months of study enrollment;
- Presence of cognitive complaints (NSI score of 3 or higher on any of the four cognitive symptoms)
- Ability to understand and communicate in English.
Exclusion Criteria:
- Medical/psychiatric/neurologic co-morbidities of: blindness/low vision; uncontrolled seizure disorder; psychosis; history of moderate, severe TBI or penetrating BI; or Spinal Cord Injury with no use of upper extremities;
- Active participation in intensive (> 5 appointments per week) treatment for amputation, orthopedic trauma, burns, substance abuse, or post-traumatic stress disorder which would preclude full participation in an intensive cognitive rehabilitation program; or
- Daily use of narcotic pain medication(s).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Standard of Care for mTBI Provider Arm
Arm 1: Psychoeducational Control Group.
Individuals assigned to arm 1 will receive psychoeducational materials specifically adapted for persistent management of symptoms and routine follow-up with medical providers (every three weeks).
Additionally, subjects assigned to this group will receive medical care (e.g., psychopharmacological management of depression) and/or referral for symptom management (e.g., vestibular rehabilitation) of non-cognitive complaints, consistent with the current standard of care treatment model for managing post-concussive symptoms (see Figure below adapted with permission from authors; Brenner et al., 2009).
|
Provider based visits every three weeks and informational handout given to patient in regulation with current standard of care procedures.
|
Experimental: Computer Based Therapy Group
Arm 2: Non-therapist directed computerized cognitive rehabilitation.
Individuals assigned to treatment arm 2 will receive ten hours of in-clinic, computerized treatment per week throughout the 6-week treatment trial.
Participants will be scheduled for 2 hours per day, proctored by clinic staff (certified recreation therapist or neuropsychology technician) who will be responsible for recording daily performance, providing positive reinforcement of participation, and effort.
Computer programs selected for this treatment trial include both skill-specific training (e.g., attention processes) and general cognitive activation.
These computer programs are commercially available and advertised as "brain fitness" or "brain training."
|
Provider based visits every three weeks and informational handout given to patient in regulation with current standard of care procedures.
POSIT
Other Names:
|
Experimental: Cognitive Rehab Group
Arm 3: Therapist-directed individualized cognitive rehabilitation.
Individuals assigned to treatment arm 3 will receive 10 hours of individual and group cognitive rehabilitation treatment (including homework assignments) per week conducted by credentialed speech therapists and occupational therapists.
The treatment components will include five hours of weekly individual therapy (one-hour sessions; two hours focused on compensatory strategies and three hours focused on restorative strategies), two hours of weekly group therapy (one hour sessions focused on compensatory strategies), and three hours of weekly computer-based "homework" proctored by clinic staff who will be responsible for recording performance, and providing positive reinforcement of participation and effort.
|
Provider based visits every three weeks and informational handout given to patient in regulation with current standard of care procedures.
APT-III, Other standard individual and group interventions.
Other Names:
|
Experimental: Cognitive and Psychological Based Rehab
Arm 4: Integrated interdisciplinary cognitive rehabilitation combined with cognitive-behavioral psychotherapy.
Individuals assigned to treatment arm 4 will receive 10 hours of individual and group treatment per week conducted by credentialed therapists and doctoral-level psychologists.
The treatment components will include four hours of weekly 1 hr individual therapy sessions; 2 hrs of cognitive rehabilitation, 1 hr of cognitive rehab & 1 hr of individual psychotherapy targeting anxiety/combat stress symptoms including relaxation training & exposure therapy and cognitive-behavioral principles, 3 hrs of weekly group therapy & three hours of weekly "homework" including 30-mins relaxation training, 30-mins cognitive-behavioral psychotherapy homework, and 2 hrs of computerized cognitive rehabilitation exercises proctored by clinic staff.
|
Provider based visits every three weeks and informational handout given to patient in regulation with current standard of care procedures.
APT-III, Other standard individual and group interventions.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Emotional Functioning
Time Frame: Baseline
|
Symptom Checklist-90-Revised (SCL-90-R) Global Severity Index and 9 subscales: Somatization; Obsessive-Compulsive; Interpersonal Sensitivity; Depression; Anxiety; Hostility; Phobic Anxiety; Paranoid Ideation, and Psychoticism |
Baseline
|
Cognitive Efficiency
Time Frame: Baseline
|
Paced Auditory Serial Addition Test (PASAT)
|
Baseline
|
Functional Behaviors
Time Frame: Baseline
|
Key Behaviors Change Inventory (KBCI) Total score Inattention- raw & T-score Impulsivity- raw & T-score Unawareness of Problems - raw & T-score Apathy - raw & T-score Interpersonal Difficulties - raw & T-score Communication Problems - raw & T-score Somatic Difficulties - raw & T-score Emotional Adjustment - raw & T-score 64 individual items
|
Baseline
|
Emotional Functioning
Time Frame: 3 Weeks
|
Symptom Checklist-90-Revised (SCL-90-R) Global Severity Index and 9 subscales: Somatization; Obsessive-Compulsive; Interpersonal Sensitivity; Depression; Anxiety; Hostility; Phobic Anxiety; Paranoid Ideation, and Psychoticism |
3 Weeks
|
Emotional Functioning
Time Frame: 6 Weeks
|
Symptom Checklist-90-Revised (SCL-90-R) Global Severity Index and 9 subscales: Somatization; Obsessive-Compulsive; Interpersonal Sensitivity; Depression; Anxiety; Hostility; Phobic Anxiety; Paranoid Ideation, and Psychoticism |
6 Weeks
|
Emotional Functioning
Time Frame: 12 Weeks
|
Symptom Checklist-90-Revised (SCL-90-R) Global Severity Index and 9 subscales: Somatization; Obsessive-Compulsive; Interpersonal Sensitivity; Depression; Anxiety; Hostility; Phobic Anxiety; Paranoid Ideation, and Psychoticism |
12 Weeks
|
Emotional Functioning
Time Frame: 18 Weeks
|
Symptom Checklist-90-Revised (SCL-90-R) Global Severity Index and 9 subscales: Somatization; Obsessive-Compulsive; Interpersonal Sensitivity; Depression; Anxiety; Hostility; Phobic Anxiety; Paranoid Ideation, and Psychoticism |
18 Weeks
|
Cognitive Efficiency
Time Frame: 3 Weeks
|
Paced Auditory Serial Addition Test (PASAT)
|
3 Weeks
|
Cognitive Efficiency
Time Frame: 6 Weeks
|
Paced Auditory Serial Addition Test (PASAT)
|
6 Weeks
|
Cognitive Efficiency
Time Frame: 12 Weeks
|
Paced Auditory Serial Addition Test (PASAT)
|
12 Weeks
|
Cognitive Efficiency
Time Frame: 18 Weeks
|
Paced Auditory Serial Addition Test (PASAT)
|
18 Weeks
|
Functional Behaviors
Time Frame: 3 Weeks
|
Key Behaviors Change Inventory (KBCI) Total score Inattention- raw & T-score Impulsivity- raw & T-score Unawareness of Problems - raw & T-score Apathy - raw & T-score Interpersonal Difficulties - raw & T-score Communication Problems - raw & T-score Somatic Difficulties - raw & T-score Emotional Adjustment - raw & T-score 64 individual items
|
3 Weeks
|
Functional Behaviors
Time Frame: 6 Weeks
|
Key Behaviors Change Inventory (KBCI) Total score Inattention- raw & T-score Impulsivity- raw & T-score Unawareness of Problems - raw & T-score Apathy - raw & T-score Interpersonal Difficulties - raw & T-score Communication Problems - raw & T-score Somatic Difficulties - raw & T-score Emotional Adjustment - raw & T-score 64 individual items
|
6 Weeks
|
Functional Behaviors
Time Frame: 12 Weeks
|
Key Behaviors Change Inventory (KBCI) Total score Inattention- raw & T-score Impulsivity- raw & T-score Unawareness of Problems - raw & T-score Apathy - raw & T-score Interpersonal Difficulties - raw & T-score Communication Problems - raw & T-score Somatic Difficulties - raw & T-score Emotional Adjustment - raw & T-score 64 individual items
|
12 Weeks
|
Functional Behaviors
Time Frame: 18 Weeks
|
Key Behaviors Change Inventory (KBCI) Total score Inattention- raw & T-score Impulsivity- raw & T-score Unawareness of Problems - raw & T-score Apathy - raw & T-score Interpersonal Difficulties - raw & T-score Communication Problems - raw & T-score Somatic Difficulties - raw & T-score Emotional Adjustment - raw & T-score 64 individual items
|
18 Weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Fatigue
Time Frame: Baseline
|
Fatigue Severity Scale (FSS) Total Raw scale 9 individual items
|
Baseline
|
Post-Concussive Symptoms
Time Frame: Baseline
|
Neurobehavioral Symptom Inventory Total Raw scale 22 individual items
|
Baseline
|
Self Reported Quality of Life
Time Frame: Baseline
|
World Health Organization Brief Quality of Life Scale (WHO-QOL-BREF) Total transformed score Total score for each of the 5 subscale domains: Overall Functioning Physical Capacity Psychological Social Relationships Environment |
Baseline
|
Neuropsychological Status
Time Frame: Baseline
|
Neuropsychological Global Composite Score Average normative t-score of: [CVLT-2 sum trials 1-5, D-KEFS Verbal Fluency total score, Trail Making Test - part B only, WAIS-IV Processing Speed, Working, CVLT- 2 Trial 1, CVLT-2 Trial 2, CVLT- 2 Trial 3, CVLT-2 Trial 4, CVLT-2 Trial 5, CVLT-2 Total Trials 1-5, CVLT-2 Total Trials 1-5 (T-score), CVLT-2 List B, SDFR, SDCR, LDFR, LDCR, total perseverations,total intrusions CVLT-2 LD recognition hits CVLT-2 LD recognition FP errors Trails part A, Trails part B, Trails part A, Trails part B, WAIS-IV Processing Speed Index, WAIS-IV Symbol Search
|
Baseline
|
Self Reported Alcohol Use Behaviors
Time Frame: Baseline
|
Alcohol Use Disorders Identification Test (AUDIT) Summary Socre; 10 individual items
|
Baseline
|
Post-Traumatic Stress Symptomatology
Time Frame: 18 Weeks
|
Post-Traumatic Stress Checklist-Military Form (PCL-M) Total Raw Socre 17 items
|
18 Weeks
|
Self Reported Headache Disability
Time Frame: Baseline
|
Headache Impact Test-6 (HIT-6) Total Weighted Score
|
Baseline
|
Health Related (Cognition) Locus of Control
Time Frame: Baseline
|
Multidimensional Health Locus of Control Scale (MHLCS-Form C) Internal subscale-total raw Chance subscale-total raw Powerful others subscale-total raw Doctors subscale-total raw Other people subscale-total raw
|
Baseline
|
Perceived Self-Efficacy (Cognition)
Time Frame: Baseline
|
Self-Efficacy for Symptom Management Scale SEsx total SEsocial subscale SEemotional subscale SEcognitvie subscale 13 individual items
|
Baseline
|
Attribution of Cognitive Symptoms
Time Frame: Baseline
|
Cognitive Symptom Attribution Scale 7 individual items
|
Baseline
|
Therapist-Rated Patient Engagement in Treatment
Time Frame: Week 6 of treatment
|
Rehabilitation Intensity of Therapy Scale (RITS) Weekly average rating (weeks 1-6)
|
Week 6 of treatment
|
Post-Concussive Symptoms
Time Frame: 6 Weeks
|
Neurobehavioral Symptom Inventory (NSI) Total Raw scale 22 individual items
|
6 Weeks
|
Post-Concussive Symptoms
Time Frame: 12 weeks
|
Neurobehavioral Symptom Inventory (NSI) Total Raw scale 22 individual items
|
12 weeks
|
Post-Concussive Symptoms
Time Frame: 18 weeks
|
Neurobehavioral Symptom Inventory (NSI) Total Raw scale 22 individual items
|
18 weeks
|
Fatigue
Time Frame: 6 weeks
|
Fatigue Severity Scale (FSS) Total Raw scale 9 individual items
|
6 weeks
|
Fatigue
Time Frame: 12 Weeks
|
Fatigue Severity Scale (FSS) Total Raw scale 9 individual items
|
12 Weeks
|
Fatigue
Time Frame: 18 Weeks
|
Fatigue Severity Scale (FSS) Total Raw scale 9 individual items
|
18 Weeks
|
Change in Healthcare Utilization
Time Frame: 30 days prior to Baseline and 6 months post Baseline
|
Summed total number of appointments 30 days prior to study enrollment and summed total number of appointments for 30 days between 5 and 6 months post-treatment.
|
30 days prior to Baseline and 6 months post Baseline
|
Self Reported Quality of Life
Time Frame: 6 weeks
|
World Health Organization Brief Quality of Life Scale (WHO-QOL-BREF) Total transformed score Total score for each of the 5 subscale domains: Overall Functioning Physical Capacity Psychological Social Relationships Environment |
6 weeks
|
Self Reported Quality of Life
Time Frame: 12 weeks
|
World Health Organization Brief Quality of Life Scale (WHO-QOL-BREF) Total transformed score Total score for each of the 5 subscale domains: Overall Functioning Physical Capacity Psychological Social Relationships Environment |
12 weeks
|
Self Reported Quality of Life
Time Frame: 18 weeks
|
World Health Organization Brief Quality of Life Scale (WHO-QOL-BREF) Total transformed score Total score for each of the 5 subscale domains: Overall Functioning Physical Capacity Psychological Social Relationships Environment |
18 weeks
|
Neuropsychological Status
Time Frame: 6 Weeks
|
Neuropsychological Global Composite Score Average normative t-score of: [CVLT-2 sum trials 1-5, D-KEFS Verbal Fluency total score, Trail Making Test - part B only, WAIS-IV Processing Speed, Working, CVLT- 2 Trial 1, CVLT-2 Trial 2, CVLT- 2 Trial 3, CVLT-2 Trial 4, CVLT-2 Trial 5, CVLT-2 Total Trials 1-5, CVLT-2 Total Trials 1-5 (T-score), CVLT-2 List B, SDFR, SDCR, LDFR, LDCR, total perseverations,total intrusions CVLT-2 LD recognition hits CVLT-2 LD recognition FP errors Trails part A, Trails part B, Trails part A, Trails part B, WAIS-IV Processing Speed Index, WAIS-IV Symbol Search
|
6 Weeks
|
Neuropsychological Status
Time Frame: 12 Weeks
|
Neuropsychological Global Composite Score Average normative t-score of: [CVLT-2 sum trials 1-5, D-KEFS Verbal Fluency total score, Trail Making Test - part B only, WAIS-IV Processing Speed, Working, CVLT- 2 Trial 1, CVLT-2 Trial 2, CVLT- 2 Trial 3, CVLT-2 Trial 4, CVLT-2 Trial 5, CVLT-2 Total Trials 1-5, CVLT-2 Total Trials 1-5 (T-score), CVLT-2 List B, SDFR, SDCR, LDFR, LDCR, total perseverations,total intrusions CVLT-2 LD recognition hits CVLT-2 LD recognition FP errors Trails part A, Trails part B, Trails part A, Trails part B, WAIS-IV Processing Speed Index, WAIS-IV Symbol Search
|
12 Weeks
|
Neuropsychological Status
Time Frame: 18 Weeks
|
Neuropsychological Global Composite Score Average normative t-score of: [CVLT-2 sum trials 1-5, D-KEFS Verbal Fluency total score, Trail Making Test - part B only, WAIS-IV Processing Speed, Working, CVLT- 2 Trial 1, CVLT-2 Trial 2, CVLT- 2 Trial 3, CVLT-2 Trial 4, CVLT-2 Trial 5, CVLT-2 Total Trials 1-5, CVLT-2 Total Trials 1-5 (T-score), CVLT-2 List B, SDFR, SDCR, LDFR, LDCR, total perseverations,total intrusions CVLT-2 LD recognition hits CVLT-2 LD recognition FP errors Trails part A, Trails part B, Trails part A, Trails part B, WAIS-IV Processing Speed Index, WAIS-IV Symbol Search
|
18 Weeks
|
Self Reported Alcohol Use Behaviors
Time Frame: 6 weeks
|
Alcohol Use Disorders Identification Test (AUDIT) Summary Socre; 10 individual items
|
6 weeks
|
Self Reported Alcohol Use Behaviors
Time Frame: 12 weeks
|
Alcohol Use Disorders Identification Test (AUDIT) Summary Socre; 10 individual items
|
12 weeks
|
Self Reported Alcohol Use Behaviors
Time Frame: 18 weeks
|
Alcohol Use Disorders Identification Test (AUDIT) Summary Socre; 10 individual items
|
18 weeks
|
Post-Traumatic Stress Symptomatology
Time Frame: 6 weeks
|
Post-Traumatic Stress Checklist-Military Form (PCL-M) Total Raw Socre 17 items
|
6 weeks
|
Post-Traumatic Stress Symptomatology
Time Frame: Baseline
|
Post-Traumatic Stress Checkilist-Military Form (PCL-M) Total Raw Socre 17 items
|
Baseline
|
Post-Traumatic Stress Symptomatology
Time Frame: 12 Weeks
|
Post-Traumatic Stress Checklist-Military Form (PCL-M) Total Raw Socre 17 items
|
12 Weeks
|
Self Reported Headache Disability
Time Frame: 6 weeks
|
Headache Impact Test-6 (HIT-6) Total Weighted Score
|
6 weeks
|
Self Reported Headache Disability
Time Frame: 12 weeks
|
Headache Impact Test-6 (HIT-6) Total Weighted Score
|
12 weeks
|
Self Reported Headache Disability
Time Frame: 18 Weeks
|
Headache Impact Test-6 (HIT-6) Total Weighted Score
|
18 Weeks
|
Health Related (Cognition) Locus of Control
Time Frame: 6 weeks
|
Multidimensional Health Locus of Control Scale (MHLCS-Form C) Internal subscale-total raw Chance subscale-total raw Powerful others subscale-total raw Doctors subscale-total raw Other people subscale-total raw
|
6 weeks
|
Health Related (Cognition) Locus of Control
Time Frame: 12 weeks
|
Multidimensional Health Locus of Control Scale (MHLCS-Form C) Internal subscale-total raw Chance subscale-total raw Powerful others subscale-total raw Doctors subscale-total raw Other people subscale-total raw
|
12 weeks
|
Health Related (Cognition) Locus of Control
Time Frame: 18 weeks
|
Multidimensional Health Locus of Control Scale (MHLCS-Form C) Internal subscale-total raw Chance subscale-total raw Powerful others subscale-total raw Doctors subscale-total raw Other people subscale-total raw
|
18 weeks
|
Perceived Self-Efficacy (Cognition)
Time Frame: 6 weeks
|
Self-Efficacy for Symptom Management Scale SEsx total SEsocial subscale SEemotional subscale SEcognitvie subscale 13 individual items
|
6 weeks
|
Perceived Self-Efficacy (Cognition)
Time Frame: 12 weeks
|
Self-Efficacy for Symptom Management Scale SEsx total SEsocial subscale SEemotional subscale SEcognitvie subscale 13 individual items
|
12 weeks
|
Perceived Self-Efficacy (Cognition)
Time Frame: 18 weeks
|
Self-Efficacy for Symptom Management Scale SEsx total SEsocial subscale SEemotional subscale SEcognitvie subscale 13 individual items
|
18 weeks
|
Attribution of Cognitive Symptoms
Time Frame: 6 weeks
|
Cognitive Symptom Attribution Scale 7 individual items
|
6 weeks
|
Attribution of Cognitive Symptoms
Time Frame: 12 weeks
|
Cognitive Symptom Attribution Scale 7 individual items
|
12 weeks
|
Attribution of Cognitive Symptoms
Time Frame: 18 weeks
|
Cognitive Symptom Attribution Scale 7 individual items
|
18 weeks
|
Therapist-Rated Patient Engagement in Treatment
Time Frame: Week 1 of Treatment
|
Rehabilitation Intensity of Therapy Scale (RITS) Weekly average rating (weeks 1-6)
|
Week 1 of Treatment
|
Therapist-Rated Patient Engagement in Treatment
Time Frame: Week 2 of treatment
|
Rehabilitation Intensity of Therapy Scale (RITS) Weekly average rating (weeks 1-6)
|
Week 2 of treatment
|
Therapist-Rated Patient Engagement in Treatment
Time Frame: Week 3 of treatment
|
Rehabilitation Intensity of Therapy Scale (RITS) Weekly average rating (weeks 1-6)
|
Week 3 of treatment
|
Therapist-Rated Patient Engagement in Treatment
Time Frame: Week 4 of treatment
|
Rehabilitation Intensity of Therapy Scale (RITS) Weekly average rating (weeks 1-6)
|
Week 4 of treatment
|
Therapist-Rated Patient Engagement in Treatment
Time Frame: Week 5 of treatment
|
Rehabilitation Intensity of Therapy Scale (RITS) Weekly average rating (weeks 1-6)
|
Week 5 of treatment
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Amy O Bowles, MD, BAMC
Publications and helpful links
General Publications
- Vanderploeg RD, Cooper DB, Curtiss G, Kennedy JE, Tate DF, Bowles AO. Predicting treatment response to cognitive rehabilitation in military service members with mild traumatic brain injury. Rehabil Psychol. 2018 May;63(2):194-204. doi: 10.1037/rep0000215.
- Cooper DB, Bowles AO, Kennedy JE, Curtiss G, French LM, Tate DF, Vanderploeg RD. Cognitive Rehabilitation for Military Service Members With Mild Traumatic Brain Injury: A Randomized Clinical Trial. J Head Trauma Rehabil. 2017 May/Jun;32(3):E1-E15. doi: 10.1097/HTR.0000000000000254.
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Neurologic Manifestations
- Neurobehavioral Manifestations
- Craniocerebral Trauma
- Trauma, Nervous System
- Consciousness Disorders
- Head Injuries, Closed
- Wounds, Nonpenetrating
- Brain Injuries
- Wounds and Injuries
- Brain Injuries, Traumatic
- Unconsciousness
- Brain Concussion
Other Study ID Numbers
- C.2010.199
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Traumatic Brain Injury With Brief Loss of Consciousness
-
Indiana UniversityRecruitingTraumatic Brain Injury | Concussion, Severe | Concussion, Intermediate | Concussion With Brief Loss of Consciousness | Traumatic Brain Injury With Brief Loss of Consciousness | Traumatic Brain Injury With No Loss of Consciousness | Concussion With LOC 31 to 59 Minutes | Traumatic Brain Injury With... and other conditionsUnited States
-
Clionsky Neuro Systems Inc.CompletedBrain Injuries | TBI (Traumatic Brain Injury) | Motor Vehicle Accidents | Brain Concussion | Brain Contusion | Traumatic Brain Injury With Brief Loss of Consciousness | Cerebral Concussion | Accidents, Traffic | Traumatic Brain Injury With Loss of Consciousness | Traffic Accidents | Cortical Contusion | Concussion... and other conditionsUnited States
-
General Hospital of Ningxia Medical UniversityUnknownTraumatic Brain Injury With Brief Loss of ConsciousnessChina
-
Haukeland University HospitalUllevaal University Hospital; Stiftelsen Helse og RehabiliteringCompletedTraumatic Brain Injury With Brief Loss of ConsciousnessNorway
-
U.S. Army Medical Research and Development CommandCompletedPost-Concussion Syndrome | Traumatic Brain Injury With Brief Loss of ConsciousnessUnited States
-
Seoul National University HospitalCompletedTraumatic Brain Injury With Prolonged Loss of ConsciousnessKorea, Republic of
-
Fondazione IRCCS San Gerardo dei TintoriFondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico; A.O. Ospedale Papa... and other collaboratorsRecruitingTraumatic Brain Injury With Loss of ConsciousnessItaly
-
Cairo UniversityCompletedTraumatic Brain Injury With Loss of ConsciousnessEgypt
-
Kessler FoundationNew Jersey Medical SchoolActive, not recruitingTraumatic Brain Injury With Loss of ConsciousnessUnited States
-
Unity Health TorontoTerminatedTraumatic Brain Injury With Prolonged Loss of ConsciousnessCanada
Clinical Trials on Informational Handout/Provider Visits
-
Boston Urogynecology AssociatesUnknownUrinary Incontinence, StressUnited States
-
University of PennsylvaniaSociety of Family PlanningCompleted
-
San Diego State UniversityCompletedType 2 Diabetes | Psychological Distress | Cardiovascular Risk Factors | Glycemic ControlUnited States
-
VA Office of Research and DevelopmentUniversity of Colorado, Denver; Memorial Sloan Kettering Cancer Center; Erasmus...Completed
-
Ethnicity and Disease Community Empowerment CenterSteward Carney Hospital; Boston Public Housing AuthorityUnknownDiabetes Mellitus | Type II DiabetesUnited States
-
The University of Texas Health Science Center,...WithdrawnA Pilot Randomized Trial of a Comprehensive Transitional Care Program for Colorectal Cancer PatientsColorectal Cancer | Comprehensive Transitional Care ProgramUnited States