Cognitive Rehabilitation in Patients With Spina Bifida

This study has been completed.
Sponsor:
Collaborators:
University of Oslo
New York University School of Medicine
The Rusk Institute of Rehabilitation Medicine
Rotman Research Institute at Baycrest
University of Toronto
Information provided by (Responsible Party):
Jan Stubberud, Sunnaas Rehabilitation Hospital
ClinicalTrials.gov Identifier:
NCT01302314
First received: February 23, 2011
Last updated: January 21, 2014
Last verified: January 2014
  Purpose

This study will examine the effects of a theoretically grounded and manualized cognitive rehabilitation program on patients with Spina Bifida (SB). SB is often associated with deficit in higher order control over cognition, emotion and behaviour; which is typically referred to as executive functions. The present study will examine the efficacy of Goal Management Training (GMT) in patients with SB that experience executive difficulties. It is expected that GMT will have a favourable effect on cognitive executive functioning, psychological and health related factors.


Condition Intervention
Executive Dysfunction
Cognitive Deficits
Spina Bifida
Behavioral: Goal management training (GMT)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Cognitive Rehabilitation in Patients With Spina Bifida: Effects on Executive Functions, Psychological and Health Related Factors

Resource links provided by NLM:


Further study details as provided by Sunnaas Rehabilitation Hospital:

Primary Outcome Measures:
  • Self and informant report of cognitive difficulties [ Time Frame: Baseline, 3 months and 6 months ] [ Designated as safety issue: No ]
    Behavior Rating Inventory for Executive Functions (BRIEF-A; Gioia et al., 2000).

  • Self and informant report of cognitive difficulties [ Time Frame: Baseline, 3 months, and 6 months ] [ Designated as safety issue: No ]
    The Dysexecutive Questionnaire (DEX; Burgess, Alderman, Emslie, Evans & Wilson, 1996).

  • self report of cognitive failures [ Time Frame: baseline, 3 months, and 6 months ] [ Designated as safety issue: No ]
    Cognitive Failures Questionnaire (Broadbent, Cooper, FitzGerald, & Parkes, 1982).

  • self report of psychological problems [ Time Frame: baseline, 3 months, and 6 months ] [ Designated as safety issue: No ]
    Symptom Checklist 25 (SCL-25; Derogatis, 1994).

  • self report of quality of life [ Time Frame: baseline, 3 months, and 6 months ] [ Designated as safety issue: No ]
    SF36 (Ware & Sherbourne, 1992).

  • Self report of coping strategies [ Time Frame: baseline, 3 months, and 6 months ] [ Designated as safety issue: No ]
    General Coping Questionnaire (GCQ-30; Joseph, Williams & Yule, 1992a).


Secondary Outcome Measures:
  • Cognitive functions measured by neuropsychological tests [ Time Frame: Baseline, 3 months and 6 months ] [ Designated as safety issue: No ]
    Tower from Delis- Kaplan Executive Function System (D-KEFS; Delis, Kaplan & Kramer, 2001).

  • Cognitive functions measured by neuropsychological tests [ Time Frame: baseline, 3 months and 6 months ] [ Designated as safety issue: No ]
    TMT from Delis- Kaplan Executive Function System (D-KEFS; Delis, Kaplan & Kramer, 2001).

  • Cognitive functions measured by neuropsychological tests [ Time Frame: baseline, 3 months, and 6 months ] [ Designated as safety issue: No ]
    Stroop from Delis- Kaplan Executive Function System (D-KEFS; Delis, Kaplan & Kramer, 2001).

  • Cognitive functions measured by neuropsychological tests [ Time Frame: baseline, 3 months and 6 months ] [ Designated as safety issue: No ]
    Conners Continuous Performance Test II (CPT-II; Conners, 2000)

  • Cognitive functions measured by neuropsychological tests [ Time Frame: baseline, 3 months and 6 months ] [ Designated as safety issue: No ]
    The Hotel Task (Manly, Hawkins, Evans, Woldt, & Robertson, 2002).


Enrollment: 38
Study Start Date: January 2011
Study Completion Date: December 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: cognitive rehabilitation Behavioral: Goal management training (GMT)
Fourteen hours of GMT during a time period of three months.

  Hide Detailed Description

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.

  Eligibility

Ages Eligible for Study:   20 Years to 46 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01302314

Locations
Norway
Sunnaas rehabilitation hospital
Oslo, Nesoddtangen, Norway, 1450
Sponsors and Collaborators
Jan Stubberud
University of Oslo
New York University School of Medicine
The Rusk Institute of Rehabilitation Medicine
Rotman Research Institute at Baycrest
University of Toronto
Investigators
Principal Investigator: Jan Stubberud, Psychologist Sunnaas Rehabilitation Hospital
  More Information

No publications provided

Responsible Party: Jan Stubberud, Neuropsychologist and PhD student, Sunnaas Rehabilitation Hospital
ClinicalTrials.gov Identifier: NCT01302314     History of Changes
Other Study ID Numbers: HSØ-2011041
Study First Received: February 23, 2011
Last Updated: January 21, 2014
Health Authority: Norway: Data Protection Authority
Norway: Directorate of Health
Norway: Regional Ethics Commitee
Norway: Ministry of Health and Care Services
Norway:National Committee for Medical and Health Research Ethics

Additional relevant MeSH terms:
Spinal Dysraphism
Neural Tube Defects
Nervous System Malformations
Nervous System Diseases
Congenital Abnormalities

ClinicalTrials.gov processed this record on September 30, 2014