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

NCT05844605 | Unknown Phase 1

• 1 other identifier: 2020330
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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

Brain Tumor

Keywords

brain tumour; prehabilitation; neuromodulation; motor training; cognitive training

Outcome Measures

Primary Outcomes (4)

• Feasibility_adherence

  Sufficient adherence is defined by attending at least 75% of the planned sessions

  Throughout the intervention, which will last approximately 10 to 20 sessions (two to four weeks)

• Feasibility_retention

  Sufficient retention is defined by at least 75% of enrolled patients completing the intervention

  Throughout the intervention, which will last approximately 10 to 20 sessions (two to four weeks)

• Feasibility_safety

  Adequate safety is defined by the absence of any serious adverse event

  Throughout the intervention, which will last approximately 10 to 20 sessions (two to four weeks)

• Feasibility_patient's satisfaction

  Self reported patient's satisfaction, as from the EORTC\* PATSAT C-33 questionnaire. All of the EORTC scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level. in this case, higher score means higher patient's satisaction of the treatment received. \*European Organisation for Research and Treatment of Cancer (EORTC)

  Throughout the intervention, which will last approximately 10 to 20 sessions (two to four weeks)

Secondary Outcomes (36)

• Clinical_Neurological Assessment in Neuro-Oncology (NANO) scale

  At baseline (before the intervention), at the end of the intervention (but before neurosurgery), and at the first available follow up (from one month up to one year after surgery)

• Clinical_Karnofsky Performance Status

  At baseline (before the intervention), at the end of the intervention (but before neurosurgery), and at the first available follow up (from one month up to one year after surgery)

• Clinical_upper limb_9 Hole Peg Test

  At baseline (before the intervention), at the end of the intervention (but before neurosurgery), and at the first available follow up (from one month up to one year after surgery)

• Clinical_upperl limb_Fugl-Meyer Upper Extremity

  At baseline (before the intervention), at the end of the intervention (but before neurosurgery), and at the first available follow up (from one month up to one year after surgery)

• Clinical_upper limb_Hand dynamometer

  At baseline (before the intervention), at the end of the intervention (but before neurosurgery), and at the first available follow up (from one month up to one year after surgery)

Study Arms (1)

Prehabilitation

EXPERIMENTAL

Adult patients affected by Brain Tumour and candidated for surgical treatment.

Procedure: Non-invasive neuromodulation (TMS and/or tDCS)

Interventions

Non-invasive neuromodulation (TMS and/or tDCS) PROCEDURE

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

Prehabilitation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Institut Guttmann: lead

Study Sites (1)

Institut Guttmann

Badalona, Catalonia, 08916, Spain

RECRUITING

Related Publications (11)

• Duffau 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 BACKGROUND

• Rivera-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 BACKGROUND

• Duffau 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 BACKGROUND

• Hamer 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 BACKGROUND

• Barcia 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 BACKGROUND

• Barcia 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 BACKGROUND

• 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.

  PMID: 32849188 BACKGROUND

• Hoogendam JM, Ramakers GM, Di Lazzaro V. Physiology of repetitive transcranial magnetic stimulation of the human brain. Brain Stimul. 2010 Apr;3(2):95-118. doi: 10.1016/j.brs.2009.10.005. Epub 2009 Nov 24.

  PMID: 20633438 BACKGROUND

• Rossi S, Antal A, Bestmann S, Bikson M, Brewer C, Brockmoller J, Carpenter LL, Cincotta M, Chen R, Daskalakis JD, Di Lazzaro V, Fox MD, George MS, Gilbert D, Kimiskidis VK, Koch G, Ilmoniemi RJ, Lefaucheur JP, Leocani L, Lisanby SH, Miniussi C, Padberg F, Pascual-Leone A, Paulus W, Peterchev AV, Quartarone A, Rotenberg A, Rothwell J, Rossini PM, Santarnecchi E, Shafi MM, Siebner HR, Ugawa Y, Wassermann EM, Zangen A, Ziemann U, Hallett M; basis of this article began with a Consensus Statement from the IFCN Workshop on "Present, Future of TMS: Safety, Ethical Guidelines", Siena, October 17-20, 2018, updating through April 2020. Safety and recommendations for TMS use in healthy subjects and patient populations, with updates on training, ethical and regulatory issues: Expert Guidelines. Clin Neurophysiol. 2021 Jan;132(1):269-306. doi: 10.1016/j.clinph.2020.10.003. Epub 2020 Oct 24.

  PMID: 33243615 BACKGROUND

• Lefaucheur JP, Aleman A, Baeken C, Benninger DH, Brunelin J, Di Lazzaro V, Filipovic SR, Grefkes C, Hasan A, Hummel FC, Jaaskelainen SK, Langguth B, Leocani L, Londero A, Nardone R, Nguyen JP, Nyffeler T, Oliveira-Maia AJ, Oliviero A, Padberg F, Palm U, Paulus W, Poulet E, Quartarone A, Rachid F, Rektorova I, Rossi S, Sahlsten H, Schecklmann M, Szekely D, Ziemann U. Evidence-based guidelines on the therapeutic use of repetitive transcranial magnetic stimulation (rTMS): An update (2014-2018). Clin Neurophysiol. 2020 Feb;131(2):474-528. doi: 10.1016/j.clinph.2019.11.002. Epub 2020 Jan 1.

  PMID: 31901449 BACKGROUND

• Boccuni L, Abellaneda-Perez K, Martin-Fernandez J, Leno-Colorado D, Roca-Ventura A, Prats Bisbe A, Buloz-Osorio EA, Bartres-Faz D, Bargallo N, Cabello-Toscano M, Pariente JC, Munoz-Moreno E, Trompetto C, Marinelli L, Villalba-Martinez G, Duffau H, Pascual-Leone A, Tormos Munoz JM. Neuromodulation-induced prehabilitation to leverage neuroplasticity before brain tumor surgery: a single-cohort feasibility trial protocol. Front Neurol. 2023 Oct 2;14:1243857. doi: 10.3389/fneur.2023.1243857. eCollection 2023.

  PMID: 37849833 DERIVED

Related Links

• webpage of the project

MeSH Terms

Conditions

Brain Neoplasms

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Central Study Contacts

Jose M Tormos Muñoz, PhD

CONTACT

0034686940393; jmtormos@guttmann.com

Kilian A Abellaneda Perez, PhD

CONTACT

0034628906400; kabellaneda@guttmann.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Pilot single-cohort feasibility open-label trial

Study Record Dates

• First Submitted: March 10, 2023
• First Posted: May 6, 2023
• Study Start: June 21, 2021
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: May 6, 2023

Record last verified: 2023-04

Locations

ES (1)