NCT05440682

Brief Summary

An Exploratory Interventional study to assess the effects of cranioplasty on brain network connectivity, neuropsychological and motor functioning in patients with severe acquired brain injury with pre-, post-cranioplasty and 6 months follow-up assessments.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 27, 2020

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 12, 2021

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

March 28, 2022

Completed
3 months until next milestone

First Posted

Study publicly available on registry

July 1, 2022

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 27, 2023

Completed
Last Updated

July 1, 2022

Status Verified

June 1, 2022

Enrollment Period

7 months

First QC Date

March 28, 2022

Last Update Submit

June 27, 2022

Conditions

Acquired Brain InjuryTraumatic Brain InjuryIschemic StrokeHemorrhagic Stroke

Keywords

Decompressive CraniectomyCranioplastyMRIEEGFunctional ConnectivityStructural Connectivity.

Outcome Measures

Primary Outcomes (1)

  • Changes in Mean Diffusivity values:

    \- Mean diffusivity (MD) from the Diffusion Tensor Imaging (DTI) data: a measure of brain structural integrity which describes the rotationally invariant magnitude of water diffusion within brain tissues. Higher values indicate worse tissue injury.

    pre-test: within 10 days before CP - post-test: from 30 to 40 days after CP - follow-up: from 170 to 190 days after CP

Secondary Outcomes (18)

  • Changes in fractional anisotropy values

    pre-test: within 10 days before CP - post-test: from 30 to 40 days after CP - follow-up: from 170 to 190 days after CP

  • Changes in Cognitive functioning

    pre-test: within 10 days before CP - post-test: from 30 to 40 days after CP - follow-up: from 170 to 190 days after CP

  • Changes in disability level

    pre-test: within 10 days before CP - post-test: from 30 to 40 days after CP - follow-up: from 170 to 190 days after CP

  • Changes in functional independence

    pre-test: within 10 days before CP - post-test: from 30 to 40 days after CP - follow-up: from 170 to 190 days after CP

  • Changes in level of consciousness

    pre-test: within 10 days before CP - post-test: from 30 to 40 days after CP - follow-up: from 170 to 190 days after CP

  • +13 more secondary outcomes

Study Arms (1)

CP group

EXPERIMENTAL

Pre- post-cranioplasty and 6 months follow-up MRI assessment. Each MRI session lasts about 60 minutes and will measure Diffusion Tensor Imaging, Tractography and resting state fMRI

Procedure: CP group

Interventions

CP groupPROCEDURE

Pre- post-cranioplasty and 6 months follow-up MRI assessment. Each MRI session lasts about 60 minutes and will measure Diffusion Tensor Imaging, Tractography and resting state fMRI.

CP group

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of sABI, a neurological condition due to a severe acquired brain damage (i.e., traumatic brain injury, ischemic stroke, hemorrhagic stroke) with a coma lasting at least 24 hours, according to a Glasgow Coma Scale equal or lower than 8 and/or complex and severe neurological disabilities treatable only in high specialty neurehabilitative settings.
  • Early DC, within 24 h;
  • Age between 18 and 75 years;
  • Intra-hospital rehabilitation setting (ordinary hospitalization or day hospithal);
  • Informed consent agreement.

You may not qualify if:

  • Medical instability at enrollment, defined as the acute onset of an unexplained derangement of vital parameters (i.e., temperature, blood pressure, pulse rate, respiratory rate, oxygen saturation, level of responsiveness) outside the normal range (for example, fever, acute internist conditions, etc.) and/or the onset of any new medical condition requiring unexpected additional diagnostic procedures and treatments (for example, severe pain, reduction of urinary output, etc.);
  • Post-traumatic agitation;
  • Dehiscence, in progress, of the DC surgical wound;
  • CP already performed;
  • Magnetic Resonance Imaging (MRI) absolute contraindications.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Irccs - Istituto Delle Scienze Neurologiche

Bologna, 40139, Italy

RECRUITING

MeSH Terms

Conditions

Brain InjuriesBrain Injuries, TraumaticIschemic StrokeHemorrhagic Stroke

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemWounds and InjuriesStrokeCerebrovascular DisordersVascular DiseasesCardiovascular Diseases

Central Study Contacts

Fabio La Porta, Md

CONTACT

051 622 5111fabiolaporta@mail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 28, 2022

First Posted

July 1, 2022

Study Start

October 27, 2020

Primary Completion

May 12, 2021

Study Completion

April 27, 2023

Last Updated

July 1, 2022

Record last verified: 2022-06

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)