Traumatic Brain Injury (TBI)MUBINCT01956136
Efficacy and Neural Basis of Music-based Neurological Rehabilitation for Traumatic Brain Injury
A study testing Music-based Neurological Rehabilitation (MBNR) in people with Traumatic Brain Injury (TBI), run by University of Helsinki at 3 sites in Finland.
Trial summary
Traumatic brain injury (TBI) is one of the leading causes of serious, life-long disability among adolescents and young adults. Especially the cognitive, emotional, and motors deficits caused by TBI often impair everyday psychosocial functioning, quality of life and ability to work. Read more about this study
- Who is it for?
- Ages 16 to 60 years
- Conditions the study is for
- Traumatic Brain Injury (TBI)
- What is being tested?
- Music-based Neurological Rehabilitation (MBNR)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 3 sitesFinland
- Study dates
- Mar 2014to Dec 2018
- 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 16 to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- moderate-severe TBI that has occurred ≤ 24 months ago
- cognitive symptoms
- right-handed
- living in the Helsinki metropolitan area
- able to understand the purpose of the study and provide informed consent
Who cannot join
- prior neurological or psychiatric illness or substance abuse
- prior auditory deficits (severe hearing loss, tinnitus, etc.)
- contraindications for MRI (pacemaker, metal prosthesis, etc.)
Trial locations and contacts
3 sites in 1 country.
Finland3 sites
Helsinki University Central Hospital / Brain Injury Outpatients Clinic
Helsinki
Validia Rehabilitation Helsinki
Helsinki
Lohja Hospital, Department of Neurology
Lohja
About this study
Traumatic brain injury (TBI) is one of the leading causes of serious, life-long disability among adolescents and young adults. Especially the cognitive, emotional, and motors deficits caused by TBI often impair everyday psychosocial functioning, quality of life and ability to work. The purpose of the study is to determine the long-term effect of music-based rehabilitation on cognitive, motor, emotional, and social recovery after TBI in adolescents and young adults, and to study the neural mechanisms that underlie behavioural recovery and the efficacy of music.
Read the detailed description
Traumatic brain injury (TBI) is one of the leading causes of serious, life-long disability among adolescents and young adults. Especially the cognitive, emotional, and motors deficits caused by TBI often impair everyday psychosocial functioning, quality of life (QoL) and ability to work dramatically, thereby bringing about a lot of suffering and burden to the patients and their families as well as substantial social and economic costs to the society. Early rehabilitation is highly important for restoring lost skills and functioning, but often very difficult given the severity and extent of the TBI symptoms and the high strain that the available rehabilitation methods put on the patients. Music therapy is a highly motivating, versatile, and applicable form of TBI rehabilitation, but currently there is little scientific evidence for its efficacy or mechanisms in the TBI population. The purpose of the present project is to determine the long-term effect of Music-based Neurological Rehabilitation (MBNR) on cognitive, motor, emotional, and social recovery after TBI in adolescents and young adults, and to study the neural mechanisms that underlie behavioural recovery and the efficacy of music.
The study is a single-blind, cross-over randomized controlled trial (RCT) involving 60 adolescents and young adults with a subacute moderate / severe TBI. During an 18-month follow-up, the patients receive MBNR (30 session, 3 x week, 1 hour sessions) and/or Standard Care (SC). The MBNR intervention utilizes structured cognitive-motor training with drums and creative musical expression (music playing, song writing) with piano that are geared towards engaging and training attention, executive functions, working memory, and upper-extremity functions and for enhancing emotional self-expression, adjustment, and mood after TBI. The SC consists of other types of conventional rehabilitation (e.g., physical therapy, neuropsychological rehabilitation) and medical care for TBI provided in private or public health care. Half of the patients receive the MBNR intervention during the first 10-week period and half during the second 10-week period (in addition, all patients receive SC during the whole follow-up period).
Outcome measures comprise neuropsychological tests (measuring executive functions, attention, reasoning, and working memory and learning), neurological scales (measuring neurological symptoms, functional outcome, adjustment, and participation), motor tests (measuring motor dexterity, coordination, and upper limb functioning), and structural and functional magnetic resonance imaging (MRI/fMRI, measuring gray and white matter structure and integrity and auditory-motor neural processing) performed at the start of the study (baseline), after the first 10-week period (3-month stage) and after the second 10-week period (6-month stage). At these time points as well as 12 months later (18-month stage), the patients and their caregivers are also given questionnaires measuring executive functions, depression symptoms, quality of life, and caregiver well-being and burden.
- Conditions
- Traumatic Brain Injury (TBI)
- Being tested
- Music-based Neurological Rehabilitation (MBNR), Standard Care (SC)
- Medical subject headings
- Brain Injuries, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Music-based Neurological Rehabilitation (MBNR)Behavioural
Music-based Neurological Rehabilitation (MBNR) will involve 10 weeks of individual training (30 sessions, 1 hour per session, 3 days per week) given by a trained music therapist. The MBNR protocol utilizes structured cognitive-motor training with drums (drum set, djembe drums) and creative musical expression (music playing, song writing) with piano that are geared towards engaging and training attention, executive functions, working memory, and upper-extremity functions and for enhancing emotional self-expression, adjustment, and mood after TBI.
Standard Care (SC)Other
Standard Care (SC) consists of other types of conventional rehabilitation (physical therapy, occupational therapy, speech therapy, and/or neuropsychological rehabilitation) and medical care for TBI that the patients receive in Finnish private or public health care.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | The patients receive 10 weeks of Music-based Neurological Rehabilitation (MBNR) and Standard Care (SC) followed by 10 weeks of SC only. Receives: Behavioral: Music-based Neurological Rehabilitation (MBNR); Other: Standard Care (SC) |
| Arm 2 | Experimental | The patients receive 10 weeks of Standard Care (SC) only followed by 10 weeks of Music-based Neurological Rehabilitation (MBNR) and SC. Receives: Behavioral: Music-based Neurological Rehabilitation (MBNR); Other: Standard Care (SC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Executive Functions during an 18-month follow-up
Executive Functions (EF) are assessed using the Behavior Rating Inventory of Executive Functions (BRIEF-A, both self-report and informant-report versions) questionnaire and following cognitive tests: Frontal Assessment Battery (FAB, measure of overall EF), Number-Letter Task (measure of set-shifting ability), Simon Task (measure of inhibition), and Auditory N-back Task (measure of working memory updating). The cognitive tests are performed at the baseline, 3-month, and 6-month stages and the BRIEF-A is performed at the baseline, 3-month, 6-month, and 18-month stages. Changes from baseline to each follow-up point (3-month / 6-month / 18-month) and between the follow-up points are evaluated.
Measured: Baseline, 3 months, 6 months, and 18 months
Change in Focused and Sustained Attention during a 6-month follow-up
Focused and Sustained Attention is assessed using the Sustained Attention to Response Task (SART) performed at the baseline, 3-month, and 6-month stages. Changes from baseline to each follow-up point (3-month / 6-month) and between the follow-up points are evaluated.
Measured: Baseline, 3 months, and 6 months
Change in Verbal Working Memory and Learning during a 6-month follow-up
Verbal Working Memory and Learning are assessed using the Digit Span subtest of the Wechsler Adult Intelligence Scale IV (WAIS-IV) and the Word List I \& II subtests of the Wechsler Memory Scale III (WMS-III) performed at the baseline, 3-month, and 6-month stages. Changes from baseline to each follow-up point (3-month / 6-month) and between the follow-up points are evaluated.
Measured: Baseline, 3 months, and 6 months
Change in Verbal and Non-Verbal Reasoning during a 6-month follow-up
Verbal and Non-Verbal Reasoning are assessed using the Similarities and Block Design subtests of the Wechsler Adult Intelligence Scale IV (WAIS-IV) performed at the baseline, 3-month, and 6-month stages. Changes from baseline to each follow-up point (3-month / 6-month) and between the follow-up points are evaluated.
Measured: Baseline, 3 months, and 6 months
Secondary outcomes (5)
Change in Upper-Extremity Motor Functions during a 6-month follow-up
Upper-Extremity Motor Functions are assessed using the Purdue Pegboard Test (PPT, measure of fine and gross motor dexterity and coordination), the Action Research Arm Test (ARAT, measure of fine and gross upper limb functioning), and the Box and Block Test (BBT, measure of unilateral manual dexterity) performed at the baseline, 3-month, and 6-month stages. Changes from baseline to each follow-up point (3-month / 6-month) and between follow-up points are evaluated.
Measured: Baseline, 3 months, and 6 months
Change in Depression during an 18-month follow-up
Depression is assessed using the Beck Depression Inventory II (BDI-II, self-report version) questionnaire performed at the baseline, 3-month, 6-month, and 18-month stages. Changes from baseline to each follow-up point (3-month / 6-month / 18-month) and between the follow-up points are evaluated.
Measured: Baseline, 3 months, 6 months, and 18 months
Change in Quality of Life during an 18-month follow-up
Quality of Life is assessed using the Quality of Life after Brain Injury (QOLIBRI, both self-report and informant-report versions) questionnaire performed at the baseline, 3-month, 6-month, and 18-month stages. Changes from baseline to each follow-up point (3-month / 6-month / 18-month) and between the follow-up points are evaluated.
Measured: Baseline, 3 months, 6 months, and 18 months
Change in Emotional Well-being of Family Members during an 18-month follow-up
Emotional Well-being of Family Members is assessed using the General Health Questionnaire (GHQ) and the Modified Caregiver Appraisal Scale (MPAI) given to the family member of the patient at the baseline, 3-month, 6-month, and 18-month stages. Changes from baseline to each follow-up point (3-month / 6-month / 18-month) and between the follow-up points are evaluated.
Measured: Baseline, 3 months, 6 months, and 18 months
Change in Structural and Functional Neuroplasticity during a 6-month follow-up
Structural and Functional Neuroplasticity is measured using structural and functional magnetic resonance imaging (MRI/fMRI) scanning performed at the baseline, 3-month, and 6-month stages. Overall, the purpose of the MRI/fMRI is to determine the exact location and size of the lesions and other pathological changes caused by the TBI and to study the changes in grey matter volume (using voxel-based morphometry, VBM), white matter volume and organization (using diffusion tensor imaging, DTI), and auditory-motor activity and connectivity (using fMRI) that take place in different brain areas during the 6-month follow-up and to correlate these changes to behavioral recovery. Changes from baseline to each follow-up point (3-month / 6-month) and between the follow-up points are studied.
Measured: Baseline, 3 months, and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2013 (estimated)
- Study startMar 2014
- Primary completionDec 2017
- Study completionDec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Traumatic Brain Injury (TBI)Studies 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
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Helsinki
- Sponsor type
- University, hospital or other
- Collaborators
- Helsinki University Central Hospital, Hospital District of Helsinki and Uusimaa, University of Jyvaskyla, Åbo Akademi University, University of Barcelona, University of Virginia, Validia Rehabilitation Helsinki
- Responsible party
- Principal investigator, Teppo Sarkamo, University of Helsinki
- Investigators
- Teppo Sarkamo, PhD, Principal investigator, University of HelsinkiMari Tervaniemi, PhD, Study director, University of HelsinkiAnne Vehmas, MD, Study chair, Kapyla Rehabilitation Centre, Helsinki, Finland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01956136
- Sponsor's protocol ID
- 141106
- Acronym
- MUBI
- Status last verified
- Feb 2019
- First submitted
- 12 Sep 2013
- Last updated
- 28 Feb 2019
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Sihvonen AJ, Siponkoski ST, Martinez-Molina N, Laitinen S, Holma M, Ahlfors M, Kuusela L, Pekkola J, Koskinen S, Sarkamo T. Neurological Music Therapy Rebuilds Structural Connectome after Traumatic Brain Injury: Secondary Analysis from a Randomized Controlled Trial. J Clin Med. 2022 Apr 14;11(8):2184. doi: 10.3390/jcm11082184.
PubMed 35456277
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Neural Basis of Music-based Neurological Rehabilitation for Traumatic Brain Injury
- ClinicalTrials.gov ID
- NCT01956136
- Acronym / sponsor ID
- MUBI / 141106
- Conditions
- Traumatic Brain Injury (TBI)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of HelsinkiUniversity, hospital or other
- Collaborators
- Helsinki University Central Hospital, Hospital District of Helsinki and Uusimaa, University of Jyvaskyla, Åbo Akademi University, University of Barcelona, University of Virginia, Validia Rehabilitation Helsinki
- Study start
- Mar 2014 (actual)
- Primary completion
- Dec 2017 (actual)
- Study completion
- Dec 2018 (actual)
- First posted
- 8 Oct 2013 (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.
Traumatic brain injury (TBI) is one of the leading causes of serious, life-long disability among adolescents and young adults. Especially the cognitive, emotional, and motors deficits caused by TBI often impair everyday psychosocial functioning, quality of life and ability to work. The purpose of the study is to determine the long-term effect of music-based rehabilitation on cognitive, motor, emotional, and social recovery after TBI in adolescents and young adults, and to study the neural mechanisms that underlie behavioural recovery and the efficacy of music.
Detailed description
Traumatic brain injury (TBI) is one of the leading causes of serious, life-long disability among adolescents and young adults. Especially the cognitive, emotional, and motors deficits caused by TBI often impair everyday psychosocial functioning, quality of life (QoL) and ability to work dramatically, thereby bringing about a lot of suffering and burden to the patients and their families as well as substantial social and economic costs to the society. Early rehabilitation is highly important for restoring lost skills and functioning, but often very difficult given the severity and extent of the TBI symptoms and the high strain that the available rehabilitation methods put on the patients. Music therapy is a highly motivating, versatile, and applicable form of TBI rehabilitation, but currently there is little scientific evidence for its efficacy or mechanisms in the TBI population. The purpose of the present project is to determine the long-term effect of Music-based Neurological Rehabilitation (MBNR) on cognitive, motor, emotional, and social recovery after TBI in adolescents and young adults, and to study the neural mechanisms that underlie behavioural recovery and the efficacy of music.
The study is a single-blind, cross-over randomized controlled trial (RCT) involving 60 adolescents and young adults with a subacute moderate / severe TBI. During an 18-month follow-up, the patients receive MBNR (30 session, 3 x week, 1 hour sessions) and/or Standard Care (SC). The MBNR intervention utilizes structured cognitive-motor training with drums and creative musical expression (music playing, song writing) with piano that are geared towards engaging and training attention, executive functions, working memory, and upper-extremity functions and for enhancing emotional self-expression, adjustment, and mood after TBI. The SC consists of other types of conventional rehabilitation (e.g., physical therapy, neuropsychological rehabilitation) and medical care for TBI provided in private or public health care. Half of the patients receive the MBNR intervention during the first 10-week period and half during the second 10-week period (in addition, all patients receive SC during the whole follow-up period).
Outcome measures comprise neuropsychological tests (measuring executive functions, attention, reasoning, and working memory and learning), neurological scales (measuring neurological symptoms, functional outcome, adjustment, and participation), motor tests (measuring motor dexterity, coordination, and upper limb functioning), and structural and functional magnetic resonance imaging (MRI/fMRI, measuring gray and white matter structure and integrity and auditory-motor neural processing) performed at the start of the study (baseline), after the first 10-week period (3-month stage) and after the second 10-week period (6-month stage). At these time points as well as 12 months later (18-month stage), the patients and their caregivers are also given questionnaires measuring executive functions, depression symptoms, quality of life, and caregiver well-being and burden.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Behavioral: Music-based Neurological Rehabilitation (MBNR), Other: Standard Care (SC)The patients receive 10 weeks of Music-based Neurological Rehabilitation (MBNR) and Standard Care (SC) followed by 10 weeks of SC only. |
| Arm 2 | Experimental | Behavioral: Music-based Neurological Rehabilitation (MBNR), Other: Standard Care (SC)The patients receive 10 weeks of Standard Care (SC) only followed by 10 weeks of Music-based Neurological Rehabilitation (MBNR) and SC. |
Who may qualify
- Ages
- 16 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- moderate-severe TBI that has occurred ≤ 24 months ago
- cognitive symptoms
- right-handed
- living in the Helsinki metropolitan area
- able to understand the purpose of the study and provide informed consent
Key exclusion criteria (3 listed)
- prior neurological or psychiatric illness or substance abuse
- prior auditory deficits (severe hearing loss, tinnitus, etc.)
- contraindications for MRI (pacemaker, metal prosthesis, etc.)
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 |
|---|---|---|
| Music-based Neurological Rehabilitation (MBNR)Music-based Neurological Rehabilitation (MBNR) will involve 10 weeks of individual training (30 sessions, 1 hour per session, 3 days per week) given by a trained music therapist. The MBNR protocol utilizes structured cognitive-motor training with drums (drum set, djembe drums) and creative musical expression (music playing, song writing) with piano that are geared towards engaging and training attention, executive functions, working memory, and upper-extremity functions and for enhancing emotional self-expression, adjustment, and mood after TBI. | Behavioural | Arm 1, Arm 2 |
| Standard Care (SC)Standard Care (SC) consists of other types of conventional rehabilitation (physical therapy, occupational therapy, speech therapy, and/or neuropsychological rehabilitation) and medical care for TBI that the patients receive in Finnish private or public health care. | Other | Arm 1, Arm 2 |
Primary outcome
Change in Executive Functions during an 18-month follow-up
Time frame: Baseline, 3 months, 6 months, and 18 months
Executive Functions (EF) are assessed using the Behavior Rating Inventory of Executive Functions (BRIEF-A, both self-report and informant-report versions) questionnaire and following cognitive tests: Frontal Assessment Battery (FAB, measure of overall EF), Number-Letter Task (measure of set-shifting ability), Simon Task (measure of inhibition), and Auditory N-back Task (measure of working memory updating). The cognitive tests are performed at the baseline, 3-month, and 6-month stages and the BRIEF-A is performed at the baseline, 3-month, 6-month, and 18-month stages. Changes from baseline to each follow-up point (3-month / 6-month / 18-month) and between the follow-up points are evaluated.
Change in Focused and Sustained Attention during a 6-month follow-up
Time frame: Baseline, 3 months, and 6 months
Focused and Sustained Attention is assessed using the Sustained Attention to Response Task (SART) performed at the baseline, 3-month, and 6-month stages. Changes from baseline to each follow-up point (3-month / 6-month) and between the follow-up points are evaluated.
Change in Verbal Working Memory and Learning during a 6-month follow-up
Time frame: Baseline, 3 months, and 6 months
Verbal Working Memory and Learning are assessed using the Digit Span subtest of the Wechsler Adult Intelligence Scale IV (WAIS-IV) and the Word List I \& II subtests of the Wechsler Memory Scale III (WMS-III) performed at the baseline, 3-month, and 6-month stages. Changes from baseline to each follow-up point (3-month / 6-month) and between the follow-up points are evaluated.
Change in Verbal and Non-Verbal Reasoning during a 6-month follow-up
Time frame: Baseline, 3 months, and 6 months
Verbal and Non-Verbal Reasoning are assessed using the Similarities and Block Design subtests of the Wechsler Adult Intelligence Scale IV (WAIS-IV) performed at the baseline, 3-month, and 6-month stages. Changes from baseline to each follow-up point (3-month / 6-month) and between the follow-up points are evaluated.
5 secondary outcomes
Change in Upper-Extremity Motor Functions during a 6-month follow-up
Time frame: Baseline, 3 months, and 6 months
Change in Depression during an 18-month follow-up
Time frame: Baseline, 3 months, 6 months, and 18 months
Change in Quality of Life during an 18-month follow-up
Time frame: Baseline, 3 months, 6 months, and 18 months
Change in Emotional Well-being of Family Members during an 18-month follow-up
Time frame: Baseline, 3 months, 6 months, and 18 months
Change in Structural and Functional Neuroplasticity during a 6-month follow-up
Time frame: Baseline, 3 months, and 6 months
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 28 Feb 2019.
- Derived from this study: PubMed 35456277Sihvonen AJ, Siponkoski ST, Martinez-Molina N, Laitinen S, Holma M, Ahlfors M, Kuusela L, Pekkola J, Koskinen S, Sarkamo T. Neurological Music Therapy Rebuilds Structural Connectome after Traumatic Brain Injury: Secondary Analysis from a Randomized Controlled Trial. J Clin Med. 2022 Apr 14;11(8):2184. doi: 10.3390/jcm11082184.
- Cognitive Brain Research Unit, Helsinki UniversityLink provided by the sponsor.
- Finnish Centre of Excellence in Interdisciplinary Music Research, University of JyvaskylaLink provided by the sponsor.
- Validia Rehabilitation HelsinkiLink provided by the sponsor.
- Cognition and Brain Plasticity Group, University of BarcelonaLink provided by the sponsor.
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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.
Teppo Sarkamo, PhD principal investigator
University of Helsinki
Mari Tervaniemi, PhD study director
University of Helsinki
Anne Vehmas, MD study chair
Kapyla Rehabilitation Centre, Helsinki, Finland
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Music-based Neurological Rehabilitation (MBNR) in people with Traumatic Brain Injury (TBI), run by University of Helsinki at 3 sites in Finland.
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 5 inclusion and 3 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 28 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Change in Executive Functions during an 18-month follow-up (time frame: Baseline, 3 months, 6 months, and 18 months). The study lists 4 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 NCT01956136, which also lists 1 linked publication.
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 28 Feb 2019.