Brain InjuriesNCT02692352
Cognitive Rehabilitation of Executive Dysfunction - Goal Management Training in Patients With Acquired Brain Injury
A study testing Goal Management Training and Brain Health Workshop in people with Brain Injuries, run by Sunnaas Rehabilitation Hospital.
Trial summary
The main objective of this study is to examine the effect of Goal Management Training for patients with executive difficulties after acquired brain injury in a randomized controlled trial. Read more about this study
- Who is it for?
- Ages 18 to 67 years
- Conditions the study is for
- Brain Injuries
- What is being tested?
- Goal Management Training and Brain Health Workshop
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- No sites listed yet
- Study dates
- Aug 2012to Jun 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 67 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Traumatic Brain Injury, stroke and resected brain tumor patients with no concomitant diseases
- Minimum 6 months post-injury/surgery
- Reporting executive problems by structured interview or baseline assessment (cognitive performance measures)
Who cannot join
- Major psychiatric disorder or reported ongoing alcohol or substance abuse
- Premorbid neurological disease or insult and/or comorbid neurological disease
- Aphasia or other specified language problems causing potential communication problems
- Impaired basic cognitive, linguistic, mnemonic, motor, or perceptual function that can interfere with the ability to engage with the training
About this study
The main objective of this study is to examine the effect of Goal Management Training for patients with executive difficulties after acquired brain injury in a randomized controlled trial. The effect on cognitive functioning will be examined, as will the relationship between treatment effects and lesion location and size. The effect of Goal Management training on regulating emotions, quality of life and coping will be examined. The generalizability of treatment effects across etiologies will be explored by comparing effects in three patient groups; traumatic brain injury, cerebrovascular accidents and resected brain tumors. Structural Magnetic Resonance Imaging (MRI) scans and measures of white matter connectivity will be used to establish detailed lesion descriptions. Functional MRI data will provide information on the neural underpinnings of treatment related change. A secondary objective is to expand the Goal Management Training protocol with increased focus on emotional regulation and adherence to homework assignment.
- Conditions
- Brain Injuries
- Being tested
- Goal Management Training, Brain Health Workshop
- Medical subject headings
- Brain Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Goal Management TrainingOther
Goal Management training, 8 sessions of 2 hours
Brain Health WorkshopOther
Brain Health Workshop training, 8 sessions of 2 hours
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | 8 sessions of Goal Management Training Receives: Other: Goal Management Training |
| Active control group | Active comparator | 8 sessions of Brain Health Workshop Receives: Other: Brain Health Workshop |
What is being measured
The primary outcome is the main question the study is designed to answer.
Executive functioning in daily life measured by self report questionnaire
Behavior Rating Inventory Executive Functions Adult version
Measured: one year
Executive functioning measured by neuropsychological assessment
Conners Continous Performance Test
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2016 (estimated)
- Study startAug 2012
- Primary completionJun 2014
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Brain InjuriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sunnaas Rehabilitation Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Oslo, University of Glasgow, Oslo University Hospital
- Responsible party
- Principal investigator, Sveinung Tornaas, Sunnaas Rehabilitation Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02692352
- Sponsor's protocol ID
- 2011/2/0204
- Status last verified
- Feb 2016
- First submitted
- 23 Feb 2016
- Last updated
- 26 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Olsen A, Dennis EL, Stubberud J, Hovenden ES, Solbakk AK, Endestad T, Kristian Hol P, Schanke AK, Lovstad M, Tornas S. Regional brain volume prior to treatment is linked to outcome after cognitive rehabilitation in traumatic brain injury. Neuroimage Clin. 2022;35:103126. doi: 10.1016/j.nicl.2022.103126. Epub 2022 Jul 28.
PubMed 36002956Tornas S, Lovstad M, Solbakk AK, Schanke AK, Stubberud J. Goal Management Training Combined With External Cuing as a Means to Improve Emotional Regulation, Psychological Functioning, and Quality of Life in Patients With Acquired Brain Injury: A Randomized Controlled Trial. Arch Phys Med Rehabil. 2016 Nov;97(11):1841-1852.e3. doi: 10.1016/j.apmr.2016.06.014. Epub 2016 Jul 15.
PubMed 27424292
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive Rehabilitation of Executive Dysfunction - Goal Management Training in Patients With Acquired Brain Injury
- ClinicalTrials.gov ID
- NCT02692352
- Acronym / sponsor ID
- 2011/2/0204
- Conditions
- Brain Injuries
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Sunnaas Rehabilitation HospitalUniversity, hospital or other
- Collaborators
- University of Oslo, University of Glasgow, Oslo University Hospital
- Study start
- Aug 2012
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 26 Feb 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main objective of this study is to examine the effect of Goal Management Training for patients with executive difficulties after acquired brain injury in a randomized controlled trial. The effect on cognitive functioning will be examined, as will the relationship between treatment effects and lesion location and size. The effect of Goal Management training on regulating emotions, quality of life and coping will be examined. The generalizability of treatment effects across etiologies will be explored by comparing effects in three patient groups; traumatic brain injury, cerebrovascular accidents and resected brain tumors. Structural Magnetic Resonance Imaging (MRI) scans and measures of white matter connectivity will be used to establish detailed lesion descriptions. Functional MRI data will provide information on the neural underpinnings of treatment related change. A secondary objective is to expand the Goal Management Training protocol with increased focus on emotional regulation and adherence to homework assignment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Other: Goal Management Training8 sessions of Goal Management Training |
| Active control group | Active comparator | Other: Brain Health Workshop8 sessions of Brain Health Workshop |
Who may qualify
- Ages
- 18 to 67 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Traumatic Brain Injury, stroke and resected brain tumor patients with no concomitant diseases
- Minimum 6 months post-injury/surgery
- Reporting executive problems by structured interview or baseline assessment (cognitive performance measures)
Key exclusion criteria (4 listed)
- Major psychiatric disorder or reported ongoing alcohol or substance abuse
- Premorbid neurological disease or insult and/or comorbid neurological disease
- Aphasia or other specified language problems causing potential communication problems
- Impaired basic cognitive, linguistic, mnemonic, motor, or perceptual function that can interfere with the ability to engage with the training
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Goal Management TrainingGoal Management training, 8 sessions of 2 hours | Other | Experimental |
| Brain Health WorkshopBrain Health Workshop training, 8 sessions of 2 hours | Other | Active control group |
Primary outcome
Executive functioning in daily life measured by self report questionnaire
Time frame: one year
Behavior Rating Inventory Executive Functions Adult version
Executive functioning measured by neuropsychological assessment
Time frame: one year
Conners Continous Performance Test
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2016.
- Derived from this study: PubMed 36002956Olsen A, Dennis EL, Stubberud J, Hovenden ES, Solbakk AK, Endestad T, Kristian Hol P, Schanke AK, Lovstad M, Tornas S. Regional brain volume prior to treatment is linked to outcome after cognitive rehabilitation in traumatic brain injury. Neuroimage Clin. 2022;35:103126. doi: 10.1016/j.nicl.2022.103126. Epub 2022 Jul 28.
- Derived from this study: PubMed 27424292Tornas S, Lovstad M, Solbakk AK, Schanke AK, Stubberud J. Goal Management Training Combined With External Cuing as a Means to Improve Emotional Regulation, Psychological Functioning, and Quality of Life in Patients With Acquired Brain Injury: A Randomized Controlled Trial. Arch Phys Med Rehabil. 2016 Nov;97(11):1841-1852.e3. doi: 10.1016/j.apmr.2016.06.014. Epub 2016 Jul 15.
- Individual participant dataSharing planned: No
Related trials for Brain Injuries
Not yet recruiting
Feasibility of a Robot-Guided Active Play Intervention for Children With Cerebral Palsy
Cerebral Palsy
Recruiting
Additional Effects on tDCS With AOT on Lower Limb Functions on Children With Diplegic CP
Diplegic Cerebral Palsy
Recruiting
Sensory Integration Therapy vs Conventional Physical Therapy in Children With Mixed Cerebral Palsy
Cerebral Palsy
Recruiting
Telerehabilitation Compared With Clinic-Based Physiotherapy in Children With Spastic Cerebral Palsy
Spastic Cerebral Palsy
Active, not recruitingObservational study
Transforming Research and Clinical Knowledge in Traumatic Brain Injury Epileptogenesis Project (TRACK-TBI EPI)
Traumatic Brain Injury, Post-traumatic Epilepsy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Goal Management Training and Brain Health Workshop in people with Brain Injuries, run by Sunnaas Rehabilitation Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Executive functioning in daily life measured by self report questionnaire (time frame: one year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02692352, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Feb 2016.