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Prehabilitation, Rehabilitation and Comprehensive Approach to the Sequelae of Brain Tumors

NCT05844605 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2023-05-06

No results posted yet for this study

Summary

The goal of the present pilot single-cohort feasibility trial is to investigate the feasibility and understand potential mechanisms of efficacy for Neuromodulation-Induced Cortical Prehabilitation (NICP) in adults with brain tumours and eligible for neurosurgery.

The main questions it aims to answer are:

* is the intervention feasible, in terms of adherence, retention, safety and patient's satisfaction;
* what are the mechanisms of neuroplasticity primed by NICP

Participants will undergo a prehabilitation protocol, consisting of daily sessions (total: 10-20 sessions) structured as follows:

* Intervention 1: non-invasive neuromodulation (TMS/tDCS).
* Intervention 2: motor and/or cognitive training, during or immediately after non-invasive neuromodulation, for about 60 minutes.

The timeline is structured as follows:

T1: baseline (before NICP) T2-T3: NICP period T4: after NICP T5: surgery T6: after surgery

Clinical, neuroimaging and neurophysiology assessments will be performed before NICP (T1), after NICP (T4), and after neurosurgery (T6). Feasibility outcomes will be determined during NICP protocol (T2-T3).

The objective of the proposed intervention is to progressively reduce the functional relevance of eloquent areas, which are healthy brain areas close with the tumour and thus exposed to the risk of being lesioned during surgery. In fact, previous studies have shown that temporary inhibition of eloquent areas (by neuromodulation) coupled with intensive motor/cognitive training promoted the activation of alternative brain resources, with a shift of functional activity from eloquent areas to areas functionally related, but anatomically distant from the tumour.

By moving the activation of key motor/cognitive functions away from the tumour, the risk of postoperative functional sequelae will be reduced; which in turn will falicitate a more radical tumour excision by the neurosurgeon.

Conditions

Interventions

PROCEDURE

Non-invasive neuromodulation (TMS and/or tDCS)

Non-invasive neuromodulation (TMS and/or tDCS) coupled with intensive behavioural training (neurorehabilitation and/or cognitive rehabilitation)

Sponsors & Collaborators

  • Institut Guttmann

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-06-21
Primary Completion
2025-12-31
Completion
2025-12-31

Countries

  • Spain

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05844605 on ClinicalTrials.gov