- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01302314
Cognitive Rehabilitation in Patients With Spina Bifida
Cognitive Rehabilitation in Patients With Spina Bifida: Effects on Executive Functions, Psychological and Health Related Factors
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
INTRODUCTION:
Rationale and purpose:
Rehabilitation of impaired cognitive processes has come to be a standard component of medical care after traumatic brain injury (TBI) or stroke (Cicerone, Dahlberg, Malec, Langenbahn, Felicitti, Kneipp, et al., 2005), and sometimes for patients with infections of the brain, hypoxic brain damage, and progressive conditions (Wilson, 2008).
The objective of this study is to determine the effects of a recently developed cognitive rehabilitation program; Goal Management Training (GMT) on the executive functioning in people with SB that have cognitive complaints. To date, research efforts have only focused on categorizing cognitive impairments in SB with no research directed towards rehabilitation for these impairments. Given the extent, nature, and ramifications of cognitive impairments in SB, studies on compensatory-based cognitive rehabilitation that teaches management strategies such as GMT may be beneficial for this population. The research questions in this study are (1) What effect does GMT have on cognitive executive functions? Furthermore, what effect does GMT have on subjective and informant evaluation of executive functioning? (2) What effect does GMT have on mental health and quality of life? (3) What effect does GMT have on coping strategies? There will be a 6 months follow-up with regard to the research questions. It is expected that GMT will have a favourable effect on executive functioning, psychological and health related factors in patients with SB.
BACKGROUND:
Medical and cognitive aspects in Spina bifida (SB):
SB is a birth defect caused by incomplete neural tube development, resulting in a protrusion of spinal cord, meninges, and nerve roots through an opening in the spine. SB is a disorder associated with a variety of brain abnormalities, usually including a congenital malformation of the cerebellum and hindbrain (Chiari II) and in about half the cases, partial dysgenesis of the corpus callosum (Barkovich, 2000). Hydrocephalus occurs in 95% of children with this disorder, with 80-90% requiring shunting (Fletcher et al., 2005). SB represents a complicated series of neural insults that begins prior to birth, with persisting effects on development, including problems in the orthopaedic, cognitive, and behavioural domains (Barkovich, 2000; Dicianno, Kurowski, Yang, et al., 2008).
Executive dysfunction:
Executive functions are higher level cognitive operations involved in the control and direction of lower level functions. Patients with executive dysfunction may experience, problems in dealing with novel situations, problems forming a reasonable plan that takes into account the relevant details, problems inhibiting habitual responses to situations when these are inappropriate, increased distractibility, problems in sustaining attention to task over time and keeping goals on-line, impaired monitoring and error-correction of behavioural output, low motivation, lack of foresight regarding the effects of one's behaviour, difficulty in regulating emotional state, and poor insight into one's difficulties (Levine, Stuss, Winocur, Binns, et al., 2007). Executive dysfunction will be examined in the present study because of the major implications deficits in this cognitive domain have for patients.
Although executive dysfunction is often associated with frontal lobe damage, it can also result from damage to other brain areas. Damage to the frontal-subcortical white matter circuits, which commonly occurs in SB, can disrupt communication between the prefrontal cortex and other areas of the brain (Dennis et al., 2006).
Cognitive rehabilitation:
Cognitive rehabilitation can be defined as a process whereby people with brain injury work together with professional staff and others to remediate or alleviate cognitive deficits arising from a neurological insult (Wilson, 2008). Treatment goals may vary, but the major goal of cognitive rehabilitation is to enable people with disabilities to function as adequately as possible in their own environments (Wilson, 2008). The effectiveness of cognitive rehabilitation is well documented within some domains for patients with stroke and TBI (e.g., Cicerone et al., 2000, 2005; Wilson, 2008; Rees et al., 2007).
The cognitive domain in focus of the present study will be executive functioning. Interventions within this domain, such as Goal Management Training (GMT), include those explicitly directed towards bridging the gap between intention and action, a deficit described as "goal neglect" with interventions targeted towards re-establishing endogenous control of behaviour.
Goal Management Training (GMT):
The present study has translated, and will use an intervention protocol that was originally developed to teach patients with brain injury a strategy to improve their ability to plan activities and to structure intentions; GMT. GMT aims to increase participants' understanding of their own goal management problems, to give them a vocabulary to describe the problems, and to give them a set of techniques to compensate for them.
GMT has been evaluated in 30 patients with mild to severe brain injury, who were randomly assigned to groups who received GMT or motor skill training. Participants who followed the GMT showed significant gains on everyday paper-and-pencil tasks designed to mimic tasks that are problematic for patients with deficits in executive functioning (Levine, Robertson, Clare, Carter, Hong, & Wilson, et al., 2000). Furthermore, Levine et al. (2007) have also applied a version of this protocol in a sample of 49 elderly with subjective cognitive complaints where results indicated improvements in simulated real-life tasks and self-rated executive deficits. These gains where maintained at long-term follow-up. Moreover, in a Dutch study (van Hooren et al., 2007) involving 37 older adults with executive difficulties, the participants in the intervention group were significantly less annoyed by their cognitive failures, were better able to manage their executive failures and reported less anxiety symptoms than those in the waiting list control group after receiving GMT.
METHODS:
The study is an experimental repeated measures design with one treatment group (n=24) and one control group (n=14), total (n=38).
Procedure:
All the patients between the age of 20 and 45 registered at TRS national resource centre for rare disorders in Norway have been asked to participate in the study (n=201). Along with the invitation was a self-report questionnaire, Behavior Rating Inventory of Executive Function-Adult Version (BRIEF-A), which the respondents had to fill out and return. Inclusion of patients was based upon one or more elevated scales on the Metacognition Index (MI). Fifty-three (n=53) subjects responded and returned the BRIEF-A questionnaire, and all fulfilled the inclusion criteria.
The baseline measurement of fifty-three (n=53) subjects in this randomised controlled trial (RCT) have been done. At baseline the participants filled out questionnaires concerning cognitive functioning, mental health, quality of life, and coping. Furthermore, neuropsychological assessments were conducted. Additionally, the Dysexecutive Questionnaire and BRIEF-A informant report form were filled out by an adult informant who were familiar with the rated individual's everyday functioning. Six subjects were excluded at baseline because they met the exclusion criteria, six subjects met the inclusion criteria but could not follow the programme at the time being because of hospitalization/illness, and three subjects could not follow the programme at the time being because of school/education. After the baseline measurement the participants were randomly assigned to GMT or control group (waiting list). The method of randomisation was a block design with block size 2, with stratification for age and education.
Twenty-four (n=24) subjects have been assigned to GMT, with six subjects in each GMT training group. The GMT is structured into seven modules. Each module is designed to run for approximately two hours. As such, the subjects will stay at TRS for three days and go through module 1 and 2. Then they go home for a month, come back and stay for three days while going through modules 3, 4 and 5. Once more, they go home for a month, come in and go through modules 6 and 7. GMT consists of tasks performed during training designed to illustrate goal management concepts in action, and homework assignments designed to facilitate transfer of the concepts to real life. Both the control group and the intervention group will be assessed immediately after the intervention group has completed the intervention, and after 6 months.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Nesoddtangen
-
Oslo, Nesoddtangen, Norway, 1450
- Sunnaas rehabilitation hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Spina bifida with myelomeningocele (MMC)
- Between 20 and 46 years of age
- Problems in the domain of executive functioning
Exclusion Criteria:
- Major psychiatric disorder
- Reported alcohol or substance abuse within the past year
- Aphasia or other specified language problems causing potential validity problems
- IQ < 70
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: cognitive rehabilitation
|
Fourteen hours of GMT during a time period of three months.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Self and informant report of cognitive difficulties
Time Frame: Baseline, 3 months and 6 months
|
Behavior Rating Inventory for Executive Functions (BRIEF-A; Gioia et al., 2000).
|
Baseline, 3 months and 6 months
|
Self and informant report of cognitive difficulties
Time Frame: Baseline, 3 months, and 6 months
|
The Dysexecutive Questionnaire (DEX; Burgess, Alderman, Emslie, Evans & Wilson, 1996).
|
Baseline, 3 months, and 6 months
|
self report of cognitive failures
Time Frame: baseline, 3 months, and 6 months
|
Cognitive Failures Questionnaire (Broadbent, Cooper, FitzGerald, & Parkes, 1982).
|
baseline, 3 months, and 6 months
|
self report of psychological problems
Time Frame: baseline, 3 months, and 6 months
|
Symptom Checklist 25 (SCL-25; Derogatis, 1994).
|
baseline, 3 months, and 6 months
|
self report of quality of life
Time Frame: baseline, 3 months, and 6 months
|
SF36 (Ware & Sherbourne, 1992).
|
baseline, 3 months, and 6 months
|
Self report of coping strategies
Time Frame: baseline, 3 months, and 6 months
|
General Coping Questionnaire (GCQ-30; Joseph, Williams & Yule, 1992a).
|
baseline, 3 months, and 6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cognitive functions measured by neuropsychological tests
Time Frame: Baseline, 3 months and 6 months
|
Tower from Delis- Kaplan Executive Function System (D-KEFS; Delis, Kaplan & Kramer, 2001).
|
Baseline, 3 months and 6 months
|
Cognitive functions measured by neuropsychological tests
Time Frame: baseline, 3 months and 6 months
|
TMT from Delis- Kaplan Executive Function System (D-KEFS; Delis, Kaplan & Kramer, 2001).
|
baseline, 3 months and 6 months
|
Cognitive functions measured by neuropsychological tests
Time Frame: baseline, 3 months, and 6 months
|
Stroop from Delis- Kaplan Executive Function System (D-KEFS; Delis, Kaplan & Kramer, 2001).
|
baseline, 3 months, and 6 months
|
Cognitive functions measured by neuropsychological tests
Time Frame: baseline, 3 months and 6 months
|
Conners Continuous Performance Test II (CPT-II; Conners, 2000)
|
baseline, 3 months and 6 months
|
Cognitive functions measured by neuropsychological tests
Time Frame: baseline, 3 months and 6 months
|
The Hotel Task (Manly, Hawkins, Evans, Woldt, & Robertson, 2002).
|
baseline, 3 months and 6 months
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Jan Stubberud, Psychologist, Sunnaas rehabilitation hospital
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- HSØ-2011041
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 Executive Dysfunction
-
Children's Hospital Medical Center, CincinnatiBrady Education FoundationCompleted
-
Florida State UniversityRecruiting
-
University of FribourgSwiss National Science Foundation; University of Bern; University of Geneva,...CompletedExecutive Dysfunction | LanguageSwitzerland
-
VA Office of Research and DevelopmentRecruitingExecutive Dysfunction | Poor Exercise AdherenceUnited States
-
University GhentUniversity Hospital, GhentCompletedChild | Motor Activity | Executive Dysfunction
-
Lawson Health Research InstituteTerminatedExecutive Dysfunction | Repetitive Transcranial Magnetic Stimulation | Gait PerformanceCanada
-
Children's National Research InstituteAppleTree Institute; The Maddux SchoolEnrolling by invitationExecutive DysfunctionUnited States
-
Xinhua Hospital, Shanghai Jiao Tong University...Unknown
-
Wayne State UniversityWithdrawnPain | Executive Dysfunction | MoodUnited States
-
Malahat AmaniCompletedExecutive Dysfunction | Obsessive-Compulsive SymptomIran, Islamic Republic of
Clinical Trials on Goal management training (GMT)
-
McMaster UniversityWorkplace Safety and Insurance BoardNot yet recruitingPost-Traumatic Stress Disorder
-
Lovisenberg Diakonale HospitalUniversity of Oslo; Oslo University Hospital; Icahn School of Medicine at Mount... and other collaboratorsRecruiting
-
Lawson Health Research InstituteCanadian Institutes of Health Research (CIHR); FDC FoundationWithdrawnPTSD | Cognitive Impairment | Cognitive Dysfunction | Cognitive Deficit | Post-traumatic Stress DisorderCanada
-
BaycrestCentre for Aging and Brain Health InnovationUnknownNeurocognitive Disorders | Cognitive Dysfunction | Mental Disorder | Cognitive Impairment, Mild | Cognitive Disorder | Nonamnestic Mild Cognitive ImpairmentCanada
-
Norwegian University of Science and TechnologyOslo University Hospital; St. Olavs Hospital; Norwegian Cancer SocietyActive, not recruitingChildhood Acute Lymphoblastic Leukemia | Childhood Acute Myeloid Leukemia | Childhood Non-Hodgkin LymphomaNorway
-
VA Office of Research and DevelopmentWithdrawnBrain Injuries, TraumaticUnited States
-
Vanderbilt University Medical CenterU.S. Department of EducationCompletedTraumatic Brain InjuryUnited States
-
BaycrestCentre for Aging and Brain Health InnovationCompletedAging | Cognitive DeclineCanada
-
BaycrestUniversity Health Network, Toronto; Sunnybrook Health Sciences Centre; McGill... and other collaboratorsCompleted
-
St. Olavs HospitalOslo University HospitalCompleted