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New treatment option for Severe Acquired Brain Injury
Official title Feasibility and Acceptability of StimolIrpinia for Cognitive Rehabilitation After Severe Acquired Brain Injury
ClinicalTrials.gov ID: NCT07718321
What this study is testing
- What it's testing
- This single-center pilot study evaluates the feasibility, acceptability, usability, and preliminary stimulus validation of StimolIrpinia, a multimedia repository of culturally and territorially relevant autobiographical stimuli designed to support cognitive rehabilitation activities in patients with severe acquired brain injury (sABI). The repository includes images, videos, maps, local cultural information, and printable materials related to the Irpinia area in Campania, Italy.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75. Healthy volunteers may be eligible.
You may be able to join if
- Patients With Severe Acquired Brain Injury - Age between 18 and 75 years.
- Level of Cognitive Functioning (LCF) score \>= 5 at study entry.
- Stable clinical diagnosis, assessed by at least four repeated LCF evaluations within a 1-week time window.
- History of severe acquired brain injury of traumatic, anoxic, vascular, or mixed etiology, defined as Glasgow Coma Scale score \<= 8 for at least 24...
- Pathological performance on at least one Oxford Cognitive Screening (OCS) subscale.
You likely can't join if
- Severe medical conditions that may prevent participation in rehabilitation sessions, including severe language deficits incompatible with...
- Age \>= 18 years.
- Proven experience in neuromotor and/or cognitive rehabilitation of patients with severe acquired brain injury.
- Written informed consent to participate in the study. Rehabilitation Professionals/Operators - Exclusion Criteria
- Participation in the development of the StimolIrpinia repository, resulting in prior familiarity with the repository.
See the full eligibility criteria
- Patients With Severe Acquired Brain Injury - Age between 18 and 75 years.
- Level of Cognitive Functioning (LCF) score \>= 5 at study entry.
- Stable clinical diagnosis, assessed by at least four repeated LCF evaluations within a 1-week time window.
- History of severe acquired brain injury of traumatic, anoxic, vascular, or mixed etiology, defined as Glasgow Coma Scale score \<= 8 for at least 24 hours after brain injury.
- Pathological performance on at least one Oxford Cognitive Screening (OCS) subscale.
- Having lived for a prolonged period in the Irpinia area, including Partenio, Valle Ufita-Baronia, Serinese-Solofrana, Alta Irpinia, Vallo di Lauro-Baianese, and/or Terminio-Cervialto.
- Written informed consent signed by the patient or by the patient's legal representative. Patients With Severe Acquired Brain Injury -
- Severe medical conditions that may prevent participation in rehabilitation sessions, including severe language deficits incompatible with understanding instructions, severe cardiovascular instability, photosensitive or...
- Age \>= 18 years.
- Proven experience in neuromotor and/or cognitive rehabilitation of patients with severe acquired brain injury.
- Written informed consent to participate in the study. Rehabilitation Professionals/Operators - Exclusion Criteria
- Participation in the development of the StimolIrpinia repository, resulting in prior familiarity with the repository.
The study team makes the final eligibility decision.
Where it's taking place
- Sant'Angelo dei Lombardi, AV, Italy
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Sant'Angelo dei Lombardi, AV, Italy. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.