Clinical trial · Interventional
Prehabilitation, Rehabilitation and Comprehensive Approach to the Sequelae of Brain Tumors
Joan Ribas Araquistain Program for Research and Therapeutic Innovation in Prehabilitation, Rehabilitation and Comprehensive Approach to the Sequelae of Brain Tumors
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Brain Tumor | Brain Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Non-invasive neuromodulation (TMS and/or tDCS) | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Prehabilitation
- description
- Adult patients affected by Brain Tumour and candidated for surgical treatment.
- interventionNames
- Procedure: Non-invasive neuromodulation (TMS and/or tDCS)
Primary outcomes (4)
- measure
- Feasibility_adherence
- timeFrame
- Throughout the intervention, which will last approximately 10 to 20 sessions (two to four weeks)
- description
- Sufficient adherence is defined by attending at least 75% of the planned sessions
- measure
- Feasibility_retention
- timeFrame
- Throughout the intervention, which will last approximately 10 to 20 sessions (two to four weeks)
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * diagnosis of brain tumour requiring neurosurgery * ability to undertake at least 10 sessions of prehabilitation protocol * tumour location posing the patient at risk of developing post-operative neurological deficits, for instance at the level of upper limb motor function and speech production * ability to understand the general purpose of the prehabilitation program and understand simple instructions * being willing to participate and sign the informed consent * being able to sit unassisted for one hour. Exclusion Criteria: * any contraindication for magnetic resonance imaging or transcranial magnetic stimulation * unstable medical conditions * musculoskeletal disorders that may significantly affect functional training * pain, depression, fatigue that may significantly affect functional training * history of alcohol/drug abuse
References
Publications (11)
- BACKGROUNDDuffau H. Lessons from brain mapping in surgery for low-grade glioma: insights into associations between tumour and brain plasticity. Lancet Neurol. 2005 Aug;4(8):476-86. doi: 10.1016/S1474-4422(05)70140-X. PMID 16033690
- BACKGROUNDRivera-Rivera PA, Rios-Lago M, Sanchez-Casarrubios S, Salazar O, Yus M, Gonzalez-Hidalgo M, Sanz A, Avecillas-Chasin J, Alvarez-Linera J, Pascual-Leone A, Oliviero A, Barcia JA. Cortical plasticity catalyzed by prehabilitation enables extensive resection of brain tumors in eloquent areas. J Neurosurg. 2017 Apr;126(4):1323-1333. doi: 10.3171/2016.2.JNS152485. Epub 2016 May 20. PMID 27203145
- BACKGROUNDDuffau H. Can Non-invasive Brain Stimulation Be Considered to Facilitate Reoperation for Low-Grade Glioma Relapse by Eliciting Neuroplasticity? Front Neurol. 2020 Nov 12;11:582489. doi: 10.3389/fneur.2020.582489. eCollection 2020. No abstract available. PMID 33304307
- BACKGROUNDHamer RP, Yeo TT. Current Status of Neuromodulation-Induced Cortical Prehabilitation and Considerations for Treatment Pathways in Lower-Grade Glioma Surgery. Life (Basel). 2022 Mar 22;12(4):466. doi: 10.3390/life12040466. PMID 35454957
- BACKGROUNDBarcia JA, Sanz A, Gonzalez-Hidalgo M, de Las Heras C, Alonso-Lera P, Diaz P, Pascual-Leone A, Oliviero A, Ortiz T. rTMS stimulation to induce plastic changes at the language motor area in a patient with a left recidivant brain tumor affecting Broca's area. Neurocase. 2012;18(2):132-8. doi: 10.1080/13554794.2011.568500. Epub 2011 Jul 25. PMID 21780986
- BACKGROUNDBarcia JA, Sanz A, Balugo P, Alonso-Lera P, Brin JR, Yus M, Gonzalez-Hidalgo M, Acedo VM, Oliviero A. High-frequency cortical subdural stimulation enhanced plasticity in surgery of a tumor in Broca's area. Neuroreport. 2012 Mar 28;23(5):304-9. doi: 10.1097/WNR.0b013e3283513307. PMID 22336871
- Serrano-Castro PJ, Ros-Lopez B, Fernandez-Sanchez VE, Garcia-Casares N, Munoz-Becerra L, Cabezudo-Garcia P, Aguilar-Castillo MJ, Vidal-Denis M, Cruz-Andreotti E, Postigo-Pozo MJ, Estivill-Torrus G, Ibanez-Botella G. Neuroplasticity and Epilepsy Surgery in Brain Eloquent Areas: Case Report. Front Neurol. 2020 Jul 29;11:698. doi: 10.3389/fneur.2020.00698. eCollection 2020.