Brain Injuries, TraumaticNCT02792985
Multisensory Stimulation and Enriched Environments During Post-traumatic Amnesia
A study testing Multisensory stimulation protocol in people with Brain Injuries, Traumatic and Confusional State, run by Institut Guttmann at 1 site in Spain.
Trial summary
The objective of this Phase II trial is to evaluate the feasibility of this study protocol to progress to a large-scale Phase III RCT in the future. It will also determine, with limited efficacy, the effectiveness of the multisensory stimulation intervention protocol to reduce the duration of post-traumatic amnesia… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Brain Injuries, Traumatic, Confusional State, Sensory Motor System Disorder
- What is being tested?
- Multisensory stimulation protocol
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSpain
- Study dates
- Aug 2015to Aug 2017
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- diagnosis of TBI
- within 6 months of their initial brain injury
- in PTA (Levels of Cognitive Function 4-6)
- appropriate visual and auditory function to observe the environment and hear instructions with or without assistive aids
- independent use of one upper limb
Who cannot join
- a previous brain injury
- illness, diseases or alcohol or drug addiction that could affect cognitive function
- having a learning disability prior to injury
- participant is out of PTA
- visual, auditory, aphasic or motor disturbance that may interfere with the ability to complete the task or participate in the sessions
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Institut Guttmann
Badalona, Barcelona, 08916
Narda Murillo, PhD, +34934977700 ext. 2146, nmurillo@guttmann.com
About this study
Official title: The Effects of Multisensory Stimulation and Enriched Environments During Post-traumatic Amnesia Following a Traumatic Brain Injury
The objective of this Phase II trial is to evaluate the feasibility of this study protocol to progress to a large-scale Phase III RCT in the future. It will also determine, with limited efficacy, the effectiveness of the multisensory stimulation intervention protocol to reduce the duration of post-traumatic amnesia (PTA), improve cognition, increase independence in activities of daily living and long term quality of life of the affected person.
Participants will be randomised into either the experimental or control group. The experimental group will follow the multisensory stimulation intervention protocol, while the control group will follow the current hospital protocol.
Read the detailed description
Design: A phase II randomised controlled trial. Repeated measures of behaviour and sensory motor performance will be taken during PTA progression for all participants. The RCT involves two treatment arms and blinded assessment post-intervention at the point of PTA resolution, one month following PTA resolution, and a 6-month post-injury follow up questionnaire. The 2 treatment groups are:
- Experimental intervention protocol: occupation-based multisensory stimulation and the use of enriched environments;
- Control intervention protocol: standard therapy as provided by the hospital which includes re-orientation and participation in basic functional tasks.
Participants: Approximately twenty participants will be recruited from the Institut Guttmann, which is a neuro-rehabilitation hospital in Badalona, Spain.
Measures:
The evaluation tools will consist of standardised, established assessments used in brain injury rehabilitation which are detailed in the Outcome Measures section.
Procedure:
Repeated measurements of behaviour and sensory motor function corresponding to the participant's progression of PTA assessment scores will be taken. The maximum number of times a single participant will be tested during PTA is 7 times and twice again following emergence from PTA, within the first 3 days and again after 1 week. All measurements are non-invasive and provide minimal adverse risks for the participant.
Participants will be randomised into either the Experimental or Control group. Participants, their family members, and the assessor taking outcome measures at the point of PTA resolution and one-month post-resolution will be blinded to group allocation and subsequent intervention protocol. Intervention provision will occur throughout the progression of PTA with post-intervention assessment to occur within 3 days of the end of PTA, one month after coming out of PTA, and through a follow-up questionnaire to be completed by the participant and family members at 6 months post-injury. All interventions are non-invasive and do not involve any risks above those that may be incurred through participation in the standard rehabilitation process.
The Experimental group will follow an intervention protocol involving transformation of the participant´s room into a sensory stimulating enriched environment (EE) and participation in occupation-based multisensory stimulation (OBMS) during their therapy sessions with an occupational therapist. They will receive two daily 30-minute individual therapy sessions.
The control group will follow the current protocol for patients in PTA at the Institut Guttmann. This includes one 30-minute individual therapy session or one hour group therapy session with an occupational therapist and minimal changes to their room (e.g. orientation board, photos of family and friends).
- Conditions
- Brain Injuries, Traumatic, Confusional State, Sensory Motor System Disorder, Alteration of Cognitive Function
- Being tested
- Multisensory stimulation protocol, Control protocol
- Medical subject headings
- Brain Injuries, Traumatic, Confusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multisensory stimulation protocolBehavioural
Participation in occupation-based multisensory stimulation (e.g. personal care with aromatic soaps, varying water temperatures and textured sponges, drink preparation of different flavoured beverages) with a variety of different sensory stimuli (e.g. strong smells, different shapes and weights). The participant will receive two individual 30-minute therapy sessions with an Occupational Therapist.
An enriched environment will be set up in the participant´s bedroom. It will include items that provide a range of meaningful sensory stimuli (e.g. familiar personal objects, projection of photos and known places, familiar music). The participant is encouraged to follow a timetable including regular rest breaks through out the day in their room.
Control protocolBehavioural
Retraining of basic activities of daily living or participation in table top tasks and games in an individual 30 minute session or a one hour small group session with an Occupational Therapist.
Minimal changes are made to the participant´s room (e.g. orientation board, photos of family and friends).
| Study group | Role | What they receive |
|---|---|---|
| Multisensory stimulation protocol | Experimental | The Experimental group will follow an intervention protocol. Receives: Behavioral: Multisensory stimulation protocol |
| Control protocol | Active comparator | The Control group will follow the current protocol for patients in PTA at the Institut Guttmann. Receives: Behavioral: Control protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acceptability
The number of participants who consent to participate compared to the number who withdraw. Further understanding of this area of feasibility will be generated by family reports of satisfaction with participation in the study and reflection of the observations recorded in the project coordinator´s daily log book.
Measured: Through study completion, up to 6 months post-injury
Demand
The percentage of eligible patients who give consent to participate in the study and the percentage that dropout after starting the study. To provide further insight of this feasibility area, analysis of demographic information of those who consent, decline or dropout will be done.
Measured: Through study completion, up to 6 months post-injury
Practicality
Brief cost analysis to identify and measure the resources required to implement the study. A record will be taken in the project coordinator´s log book of factors observed to affect efficiency, speed, quality of implementation, or any adverse events that may occur.
Measured: Through study completion, up to 6 months post-injury
Implementation
To measure this area of feasibility, the adherence to respective protocols for each participant will be taken including the number of days and amount of time participants attend therapy sessions. Moreover, assessment of the appropriateness of the secondary outcome measures and feasibility of the assessment protocol will be conducted.
Measured: Through study completion, up to 6 months post-injury
Secondary outcomes (7)
Cognitive function
Measured using the Neurobehavioral Cognitive Status Examination (COGNISTAT) which is a cognitive screening assessment.
Measured: Through study completion, up to 6 months post-injury
Duration of PTA
Measured using the Westmead PTA Scale (WPTAS). PTA duration is taken to be the number of days from the date of the initial injury until the participant achieves 12/12 on the Westmead PTA Scale.
Measured: Through study completion, up to 6 months post-injury
Visual perception performance
Measured using the Developmental Test of Visual Perception - Adolescence and Adult version to measure visual perception and visual motor integration performance.
Measured: Through study completion, up to 6 months post-injury
Functional balance
Measured using the Berg Balance Scale.
Measured: Through study completion, up to 6 months post-injury
Functional Independence
Measured using the Functional Independence Measure (FIM).
Measured: Through study completion, up to 6 months post-injury
Level of agitation
Measured using the Agitated Behavior Scale (ABS).
Measured: Through study completion, up to 6 months post-injury
Level of attention
Measured using the Moss Attention Rating Scale (MARS).
Measured: Through study completion, up to 6 months post-injury
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2016 (estimated)
- Study startAug 2015
- Primary completionFeb 2017 (estimated)
- Study completionAug 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain Injuries, TraumaticStudies 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, Care provider
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institut Guttmann
- Sponsor type
- University, hospital or other
- Collaborators
- The University of Queensland
- Responsible party
- Sponsor
- Investigators
- Narda Murillo, PhD, Principal investigator, Institut Guttmann
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02792985
- Sponsor's protocol ID
- 2014.205
- Status last verified
- Jun 2016
- First submitted
- 8 May 2016
- Last updated
- 8 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Multisensory Stimulation and Enriched Environments During Post-traumatic Amnesia Following a Traumatic Brain Injury
- ClinicalTrials.gov ID
- NCT02792985
- Acronym / sponsor ID
- 2014.205
- Conditions
- Brain Injuries, Traumatic, Confusional State, Sensory Motor System Disorder, Alteration of Cognitive Function
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Institut GuttmannUniversity, hospital or other
- Collaborators
- The University of Queensland
- Study start
- Aug 2015
- Primary completion
- Feb 2017 (estimated)
- Study completion
- Aug 2017 (estimated)
- First posted
- 8 Jun 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 objective of this Phase II trial is to evaluate the feasibility of this study protocol to progress to a large-scale Phase III RCT in the future. It will also determine, with limited efficacy, the effectiveness of the multisensory stimulation intervention protocol to reduce the duration of post-traumatic amnesia (PTA), improve cognition, increase independence in activities of daily living and long term quality of life of the affected person.
Participants will be randomised into either the experimental or control group. The experimental group will follow the multisensory stimulation intervention protocol, while the control group will follow the current hospital protocol.
Detailed description
Design: A phase II randomised controlled trial. Repeated measures of behaviour and sensory motor performance will be taken during PTA progression for all participants. The RCT involves two treatment arms and blinded assessment post-intervention at the point of PTA resolution, one month following PTA resolution, and a 6-month post-injury follow up questionnaire. The 2 treatment groups are:
- Experimental intervention protocol: occupation-based multisensory stimulation and the use of enriched environments;
- Control intervention protocol: standard therapy as provided by the hospital which includes re-orientation and participation in basic functional tasks.
Participants: Approximately twenty participants will be recruited from the Institut Guttmann, which is a neuro-rehabilitation hospital in Badalona, Spain.
Measures:
The evaluation tools will consist of standardised, established assessments used in brain injury rehabilitation which are detailed in the Outcome Measures section.
Procedure:
Repeated measurements of behaviour and sensory motor function corresponding to the participant's progression of PTA assessment scores will be taken. The maximum number of times a single participant will be tested during PTA is 7 times and twice again following emergence from PTA, within the first 3 days and again after 1 week. All measurements are non-invasive and provide minimal adverse risks for the participant.
Participants will be randomised into either the Experimental or Control group. Participants, their family members, and the assessor taking outcome measures at the point of PTA resolution and one-month post-resolution will be blinded to group allocation and subsequent intervention protocol. Intervention provision will occur throughout the progression of PTA with post-intervention assessment to occur within 3 days of the end of PTA, one month after coming out of PTA, and through a follow-up questionnaire to be completed by the participant and family members at 6 months post-injury. All interventions are non-invasive and do not involve any risks above those that may be incurred through participation in the standard rehabilitation process.
The Experimental group will follow an intervention protocol involving transformation of the participant´s room into a sensory stimulating enriched environment (EE) and participation in occupation-based multisensory stimulation (OBMS) during their therapy sessions with an occupational therapist. They will receive two daily 30-minute individual therapy sessions.
The control group will follow the current protocol for patients in PTA at the Institut Guttmann. This includes one 30-minute individual therapy session or one hour group therapy session with an occupational therapist and minimal changes to their room (e.g. orientation board, photos of family and friends).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Multisensory stimulation protocol | Experimental | Behavioral: Multisensory stimulation protocolThe Experimental group will follow an intervention protocol. |
| Control protocol | Active comparator | Behavioral: Control protocolThe Control group will follow the current protocol for patients in PTA at the Institut Guttmann. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- diagnosis of TBI
- within 6 months of their initial brain injury
- in PTA (Levels of Cognitive Function 4-6)
- appropriate visual and auditory function to observe the environment and hear instructions with or without assistive aids
- independent use of one upper limb
Key exclusion criteria (5 listed)
- a previous brain injury
- illness, diseases or alcohol or drug addiction that could affect cognitive function
- having a learning disability prior to injury
- participant is out of PTA
- visual, auditory, aphasic or motor disturbance that may interfere with the ability to complete the task or participate in the sessions
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 |
|---|---|---|
| Multisensory stimulation protocolParticipation in occupation-based multisensory stimulation (e.g. personal care with aromatic soaps, varying water temperatures and textured sponges, drink preparation of different flavoured beverages) with a variety of different sensory stimuli (e.g. strong smells, different shapes and weights). The participant will receive two individual 30-minute therapy sessions with an Occupational Therapist. An enriched environment will be set up in the participant´s bedroom. It will include items that provide a range of meaningful sensory stimuli (e.g. familiar personal objects, projection of photos and known places, familiar music). The participant is encouraged to follow a timetable including regular rest breaks through out the day in their room. | Behavioural | Multisensory stimulation protocol |
| Control protocolRetraining of basic activities of daily living or participation in table top tasks and games in an individual 30 minute session or a one hour small group session with an Occupational Therapist. Minimal changes are made to the participant´s room (e.g. orientation board, photos of family and friends). | Behavioural | Control protocol |
Primary outcome
Acceptability
Time frame: Through study completion, up to 6 months post-injury
The number of participants who consent to participate compared to the number who withdraw. Further understanding of this area of feasibility will be generated by family reports of satisfaction with participation in the study and reflection of the observations recorded in the project coordinator´s daily log book.
Demand
Time frame: Through study completion, up to 6 months post-injury
The percentage of eligible patients who give consent to participate in the study and the percentage that dropout after starting the study. To provide further insight of this feasibility area, analysis of demographic information of those who consent, decline or dropout will be done.
Practicality
Time frame: Through study completion, up to 6 months post-injury
Brief cost analysis to identify and measure the resources required to implement the study. A record will be taken in the project coordinator´s log book of factors observed to affect efficiency, speed, quality of implementation, or any adverse events that may occur.
Implementation
Time frame: Through study completion, up to 6 months post-injury
To measure this area of feasibility, the adherence to respective protocols for each participant will be taken including the number of days and amount of time participants attend therapy sessions. Moreover, assessment of the appropriateness of the secondary outcome measures and feasibility of the assessment protocol will be conducted.
7 secondary outcomes
Cognitive function
Time frame: Through study completion, up to 6 months post-injury
Duration of PTA
Time frame: Through study completion, up to 6 months post-injury
Visual perception performance
Time frame: Through study completion, up to 6 months post-injury
Functional balance
Time frame: Through study completion, up to 6 months post-injury
Functional Independence
Time frame: Through study completion, up to 6 months post-injury
Level of agitation
Time frame: Through study completion, up to 6 months post-injury
Level of attention
Time frame: Through study completion, up to 6 months post-injury
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2016.
- Individual participant dataSharing planned: No
Related trials for Brain Injuries, Traumatic
RecruitingPhase 3
Efficacy of Propranolol in Traumatic Brain Injury Patients Admitted to the ICU: A Prospective, Randomized, Triple-Blind Study
Traumatic Brain Injury (TBI) Patients
Not yet recruiting
Supplementary Neuromuscular Rehabilitation During Acute Concussion Recovery
Concussion (Diagnosis), Gait Abnormality
RecruitingObservational study
Study On Histoacryl Used For Embolization Of Middle Meningeal Artery (MMA) In Chronic Subdural Hematoma (CSDH)
Subdural Hematoma, Subdural Hematoma, Chronic
Recruiting
Feasibility and Acceptability of an LLM-based Chatbot for Family Caregivers: Evaluation Study
Caregivers
RecruitingPhase 1
Rehabilitation Through Virtual Immersion & Integrated Exposure for Mild Traumatic Brain Injury (ReVIVE for mTBI)
Traumatic Brain Injuries, TBI (Traumatic Brain Injury)
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.
Narda Murillo, PhD principal investigator
Institut Guttmann
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multisensory stimulation protocol in people with Brain Injuries, Traumatic and Confusional State, run by Institut Guttmann 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 5 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 8 Jun 2016. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hayley Walsh (+34934977700 ext. 2146, hayley.walsh@uqconnect.edu.au), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acceptability (time frame: Through study completion, up to 6 months post-injury). 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?
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 8 Jun 2016.