NCT04206475

Feasibility Randomized Trial for an Intensive Memory-Focused Training Program for School Aged Children With Acquired br.Inj.

Completed NA Last updated 6 February 2020

What this trial tests

NA trial testing rehabilitation in Acquired Brain Injury in 21 participants. Completed in 3 February 2018.

Timeline

21 October 2013

Primary endpoint
3 February 2018

3 February 2018

Quick facts

Lead sponsor	IRCCS Eugenio Medea
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	21
Start date	21 October 2013
Primary completion	3 February 2018
Estimated completion	3 February 2018
Sites	1 location across Italy

Drugs / interventions tested

• rehabilitation
• Intensive Memory-Focused Training Program (IM-FTP)

Conditions studied

• Acquired Brain Injury — all drugs for Acquired Brain Injury →

Sponsor

IRCCS Eugenio Medea — full company profile →

Who can join

Adults 6 to 18, any sex, with Acquired Brain Injury. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Memory deficits are common sequelae of pediatric Acquired Brain Injury (ABI). Only methods for non-focused cognitive remediation are available to the pediatric field. The aims of this feasibility trial are the description, implementation, and test of an intensive program specific to the training and re-adaptation of memory function in children (IM-FTP). Method: Eleven children and adolescents with ABI (mean age at injury=12.2 years, brain tumor survivors excluded) were clinically assessed and rehabilitated over 1-month through IM-FTP, including physio-kinesis/occupational, speech, and neuropsychology treatments. Each patient received a psychometric evaluation and a brain functional MRI at enrollment and at discharge. Ten pediatric controls with ABI (mean age at injury=13.8 years) were clinically assessed, and rehabilitated through a standard program.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Feasibility Randomized Trial for an Intensive Memory-Focused Training Program for School-Aged Children with Acquired Brain Injury.
   Recla M, Molteni E, Manfredi V, Arrigoni F, et al · · 2020 · cited 2× · PMID 32645968 · DOI 10.3390/brainsci10070430