Clinical trial NCT02792985: Multisensory Stimulation and Enriched Environments During Post-traumatic Amnesia
Official title: The Effects of Multisensory Stimulation and Enriched Environments During Post-traumatic Amnesia Following a Traumatic Brain Injury
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Brain Injuries, Traumatic
Confusional State
Sensory Motor System Disorder
Alteration of Cognitive Function
Lead sponsor: Institut Guttmann
Sponsor class: OTHER
Collaborators: name: The University of Queensland
First posted: 2016-06-08
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 (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:

1. Experimental intervention protocol: occupation-based multisensory stimulation and the use of enriched environments;
2. 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).

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Acceptability
timeFrame: Through study completion, up to 6 months post-injury
measure: Demand
timeFrame: Through study completion, up to 6 months post-injury
measure: Practicality
timeFrame: Through study completion, up to 6 months post-injury
measure: Implementation
timeFrame: Through study completion, up to 6 months post-injury
Secondary outcomes:
measure: Cognitive function
timeFrame: Through study completion, up to 6 months post-injury
measure: Duration of PTA
timeFrame: Through study completion, up to 6 months post-injury
measure: Visual perception performance
timeFrame: Through study completion, up to 6 months post-injury
measure: Functional balance
timeFrame: Through study completion, up to 6 months post-injury
measure: Functional Independence
timeFrame: Through study completion, up to 6 months post-injury
measure: Level of agitation
timeFrame: Through study completion, up to 6 months post-injury
measure: Level of attention
timeFrame: Through study completion, up to 6 months post-injury
Other outcomes:
Locations:
city: Badalona
country: Spain
facility: Institut Guttmann
state: Barcelona
Study officials:
affiliation: Institut Guttmann
name: Narda Murillo, PhD
role: PRINCIPAL_INVESTIGATOR
References: