Acquired Brain InjuryMeraki_ABINCT06343662
Group Music Therapy for Acquired Brain Injury
A study testing MERAKI_ABI in people with Acquired Brain Injury, run by University of Valencia at 1 site in Spain.
Trial summary
The study aims to analyse the impact of music therapy-based treatment on the comfort and well-being of patients with acquired brain injury (ABI). To achieve this objective, it is proposed to validate and implement a music therapy-based assessment and treatment protocol. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acquired Brain Injury
- What is being tested?
- MERAKI_ABI
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteSpain
- Study dates
- 1 Mar 2024to 30 Sep 2025
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient with acquired brain damage who has been admitted to the hospital for at least one week. The patient has experienced a sudden brain injury resulting in physical, psychological, cognitive, behavioural or sensory deficits that have reduced their previous functional capacity and quality of life. The patient is clinically stable enough to undergo rehabilitation and had a good functional situation prior to the episode (Barthel Index > 60).
- Be over 18 years of age.
- The participant or their relatives have signed the informed consent form.
- They have completed the group music therapy intervention session, as well as the pre-test and post-test evaluations.
Who cannot join
- Failure to obtain informed consent
- The Barthel Index score is below 60, indicating functional dependency.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Meraki: Music Therapy Protocol for People With Acquired Brain Injury
The study aims to analyse the impact of music therapy-based treatment on the comfort and well-being of patients with acquired brain injury (ABI). To achieve this objective, it is proposed to validate and implement a music therapy-based assessment and treatment protocol. The protocol will be tested in a pilot sample to improve adaptation to the disease and promote integration with the usual health measures of patients with ABI. Implementing a group treatment programme based on music therapy applied to patients with ABI.
- Conditions
- Acquired Brain Injury
- Being tested
- MERAKI_ABI
- Keywords
- music therapy-based treatment, psychological intervention, discomfort, Acquired Brain Injury
- Medical subject headings
- Brain Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MERAKI_ABIBehavioural
The music therapy session will focus on the themes of reidentification and involvement. The aim is to accompany the patient during the illness process, allowing them to express their emotional state, relate to music, promote listening and communication between family members, help and value preserved abilities, and promote personal involvement in the rehabilitation process.
The session will work with songs, taking into account musical preferences.
| Study group | Role | What they receive |
|---|---|---|
| No Intervention: Control Group | No intervention | Patients who receive the treatment program, will previously constitute their own control group (waiting list control group). |
| Experimental group | Experimental | Patients admitted to the brain injury unit will participate in a music therapy protocol starting one week after admission. Prior to the group session, three evaluations will be conducted over six days. Post-treatment assessments will also be conducted to enable longitudinal evaluation of the patient over the course of a week. Receives: Behavioral: MERAKI_ABI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Discomfort ( Baseline (3 Assessments), Pre- Post)
The Discomfort Observation Scale (DOS) is a tool used to assess discomfort in patients with severe cognitive impairment in end-of-life situations. The Discomfort Observation Scale (DOS) is a tool used to assess discomfort in patients with severe cognitive impairment in end-of-life situations. The Discomfort Observation Scale (DOS) is a tool used to assess discomfort in patients with severe cognitive impairment in end-of-life situations. It consists of nine items that evaluate factors such as noisy breathing, body language, facial expressions, and verbalizations. Each observation is scored dichotomously (0-1, presence-absence), resulting in a score range of 0 to 9. A higher score indicates less discomfort. The language used is clear, concise, and objective, adhering to formal register and precise word choice. The text is grammatically correct and follows conventional structure and formatting features.
Measured: Baseline up to 1 week
Secondary outcomes (3)
Barthel Index
The purpose of this assessment is to evaluate the patient's functional independence. It involves assessing their ability to perform 10 activities of daily living, including eating, washing, dressing, grooming, bowel movements, urination, toileting, transferring, ambulation, and stair use. The scores range from 0, indicating maximum dependence, to 100, indicating maximum independence.
Measured: Baseline
Pfeiffer Short Form Mental State Questionnaire, SPMSQ
This assessment evaluates cognitive impairment through a series of 10 questions that explore orientation, remote and working memory, as well as calculation skills. Each incorrectly answered question adds one point, and more than 2 errors suggest the presence of cognitive impairment that requires further study.
Measured: Baseline
Charlson Comorbidity Index (CCI),
This tool predicts the one-year mortality rate for patients with various comorbid conditions, including heart disease, AIDS, and cancer (a total of 8 conditions in the short version). The measure assigns a score to each condition based on the associated risk of death. A score of 0 to 1 indicates no comorbidity, 2 points indicates low comorbidity, and 3 points or more indicates high comorbidity. The total score predicts mortality.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2024
- Study start1 Mar 2024
- Primary completion31 Jul 2025
- Study completion30 Sep 2025
Why it stopped: Project termination due to the end of employment of the professionals responsible for data collection
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acquired Brain InjuryStudies of the same condition, open and under way.
- More trials run by University of ValenciaThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Valencia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, M. Antonia Pérez-Marín, University of Valencia
- Investigators
- Marián Pérez-Marín, PhD, Principal investigator, University of Valencia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06343662
- Sponsor's protocol ID
- Meraki_Acquired Brain Injury
- Acronym
- Meraki_ABI
- Status last verified
- Dec 2024
- First submitted
- 26 Mar 2024
- Last updated
- 18 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Meraki: Music Therapy Protocol for People With Acquired Brain Injury
- ClinicalTrials.gov ID
- NCT06343662
- Acronym / sponsor ID
- Meraki_ABI / Meraki_Acquired Brain Injury
- Conditions
- Acquired Brain Injury
- Keywords
- music therapy-based treatment, psychological intervention, discomfort, Acquired Brain Injury
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Project termination due to the end of employment of the professionals responsible for data collection
- Enrolment
- 27 participants (actual)
- Lead sponsor
- University of ValenciaUniversity, hospital or other
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- 31 Jul 2025 (actual)
- Study completion
- 30 Sep 2025 (actual)
- First posted
- 2 Apr 2024 (actual)
- 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 study aims to analyse the impact of music therapy-based treatment on the comfort and well-being of patients with acquired brain injury (ABI). To achieve this objective, it is proposed to validate and implement a music therapy-based assessment and treatment protocol. The protocol will be tested in a pilot sample to improve adaptation to the disease and promote integration with the usual health measures of patients with ABI. Implementing a group treatment programme based on music therapy applied to patients with ABI.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| No Intervention: Control Group | No intervention | –Patients who receive the treatment program, will previously constitute their own control group (waiting list control group). |
| Experimental group | Experimental | Behavioral: MERAKI_ABIPatients admitted to the brain injury unit will participate in a music therapy protocol starting one week after admission. Prior to the group session, three evaluations will be conducted over six days. Post-treatment assessments will also be conducted to enable longitudinal evaluation of the patient over the course of a week. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patient with acquired brain damage who has been admitted to the hospital for at least one week. The patient has experienced a sudden brain injury resulting in physical, psychological, cognitive, behavioural or sensory deficits that have reduced their previous functional capacity and quality of life. The patient is clinically stable enough to undergo rehabilitation and had a good functional situation prior to the episode (Barthel Index > 60).
- Be over 18 years of age.
- The participant or their relatives have signed the informed consent form.
- They have completed the group music therapy intervention session, as well as the pre-test and post-test evaluations.
Key exclusion criteria (2 listed)
- Failure to obtain informed consent
- The Barthel Index score is below 60, indicating functional dependency.
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 |
|---|---|---|
| MERAKI_ABIThe music therapy session will focus on the themes of reidentification and involvement. The aim is to accompany the patient during the illness process, allowing them to express their emotional state, relate to music, promote listening and communication between family members, help and value preserved abilities, and promote personal involvement in the rehabilitation process. The session will work with songs, taking into account musical preferences. | Behavioural | Experimental group |
Primary outcome
Change in Discomfort ( Baseline (3 Assessments), Pre- Post)
Time frame: Baseline up to 1 week
The Discomfort Observation Scale (DOS) is a tool used to assess discomfort in patients with severe cognitive impairment in end-of-life situations. The Discomfort Observation Scale (DOS) is a tool used to assess discomfort in patients with severe cognitive impairment in end-of-life situations. The Discomfort Observation Scale (DOS) is a tool used to assess discomfort in patients with severe cognitive impairment in end-of-life situations. It consists of nine items that evaluate factors such as noisy breathing, body language, facial expressions, and verbalizations. Each observation is scored dichotomously (0-1, presence-absence), resulting in a score range of 0 to 9. A higher score indicates less discomfort. The language used is clear, concise, and objective, adhering to formal register and precise word choice. The text is grammatically correct and follows conventional structure and formatting features.
3 secondary outcomes
Barthel Index
Time frame: Baseline
Pfeiffer Short Form Mental State Questionnaire, SPMSQ
Time frame: Baseline
Charlson Comorbidity Index (CCI),
Time frame: Baseline
Results and safety
The study was stopped early (reason given: Project termination due to the end of employment of the professionals responsible for data collection). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2026.
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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.
Marián Pérez-Marín, PhD principal investigator
University of Valencia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MERAKI_ABI in people with Acquired Brain Injury, run by University of Valencia at 1 site in Spain.
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 4 inclusion and 2 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: stopped early, as of the sponsor's last update on 18 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. 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 was stopped early (reason given: Project termination due to the end of employment of the professionals responsible for data collection). Results are not available in the source record.
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 Discomfort ( Baseline (3 Assessments), Pre- Post) (time frame: Baseline up to 1 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 May 2026.