Clinical trial · Interventional

Neuromodulation-Induced Cortical Prehabilitation in High Grade Glioma Near the Motor Pathway: Cortical Plasticity Assessed by Navigated Transcranial Magnetic Stimulation (nTMS)

Neuromodulation-Induced-Cortical-Prehabilitation In High Grade Glioma Close To The Motor Pathway: Analysis Of The Cortical Brain Plasticity Through Navigated Transacranial Magnetic Stimulation

NCT07471100CI-TRIAL-00105526not yet recruitingN/AClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

The goal of this clinical trial is to learn whether Neuromodulation-Induced-Cortical-Prehabilitation (NICP)-using physical therapy (constraint-induced movement training, CIM) alone or combined with repetitive transcranial magnetic stimulation (rTMS)-can promote motor-cortex neuroplasticity before surgery in adults with high-grade gliomas near the motor pathway. It will also learn about the feasibility and safety of these prehabilitation strategies around the time of surgery. The main questions it aims to answer are: 1. Does CIM (with or without rTMS) produce measurable motor-cortex plasticity from baseline to pre-surgery as assessed by neuronavigated TMS (nTMS)? 2. Does adding rTMS to CIM lead to greater neuroplastic changes than CIM alone? 3. What clinical, radiological, and neurophysiological outcomes are observed after surgery in participants who receive prehabilitation compared with controls? Researchers will compare standard care (control) vs CIM-based physical therapy vs CIM plus rTMS to see if these approaches induce preoperative neuroplastic changes that may support better surgical outcomes. Participants will: 1. Be randomized to one of three groups: control, CIM physical therapy, or CIM + rTMS• Undergo nTMS motor mapping and excitability testing at baseline (T0) and the day before surgery (T1) 2. Undergo planned tumor surgery (according to standard methods of care) and complete postoperative clinical, imaging, and neurophysiological follow-up assessments.

Conditions

Conditions (3)

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 Adult	Brain Neoplasm	ALIAS	0.85
Glioma	Glioma	ONTOLOGY_EXACT	0.98
Glioma, High Grade	High-Grade Glioma, NOS	ONTOLOGY_EXACT	0.90

Interventions

Interventions (2)

Intervention	Type	Mapped drug	Match
Combined Therapy Group	Procedure	—	UNRESOLVED
Physical Therapy	Procedure	—	UNRESOLVED

Design

Arms and outcomes

Arms (3)

type
NO_INTERVENTION
label
Control (no NICP)
description
Physical Therapy Group
type
EXPERIMENTAL
label
Physical Therapy Group: patients who undergo only physical therapy
description
Physical Therapy protocol for the 10 days preceding surgery: 6h/day Constraint Induced Movement - CIM (immobilization of the ipsilesional hand - unaffected side) + 1h twice a day of fine motor skills focused exercises (e.g. 9-hole peg test) on the controlateral hand (affected side)
interventionNames
1. Procedure: Physical Therapy
type
EXPERIMENTAL
label
Combined Therapy Group: patients who undergo physical therapy + rTMS
description
Repetitive Transcranial Magnetic Stimulation protocol for the 10 days preceding surgery: This will be done following standard protocols mediated from the protocols for motor and language function in stroke, i.e, daily sessions of 1Hz rTMS for 20 minutes applied to the contralesional hemisphere. • Physical Therapy protocol for the 10 days preceding surgery: 6h/day Constraint Induced Movement - CIM (immobilization of the ipsilesional hand - unaffected side) + 1h twice a day of fine motor skills focused exercises (e.g. 9-hole peg test) on the controlateral hand (affected side)

Eligibility

Eligibility (as posted)

Sex: All
Minimum age: 18 Years
Maximum age: 80 Years

Show eligibility criteria text

Inclusion Criteria:

1. Age 18-80
2. Suspect of High Grade Glioma in MRI
3. Any case of cortical/subcortical HGG radiologically close to Motor Pathway and, thus, where intraoperative monitoring assistance is usually required
4. Preservation of motor function (at least ≥ 3 according to Medical Research Council classification)
5. Signed informed Consent

Exclusion Criteria:

1. Refusal to Study participation
2. Multifocal/Bilateral Disease

References

Publications (6)

RESULTBoccuni L, Roca-Ventura A, Buloz-Osorio E, Leno-Colorado D, Delgado-Gallen S, Cabello-Toscano M, Perellon-Alfonso R, Villalba-Martinez G, Martinez-Ricarte F, Martin-Fernandez J, Buxeda-Rodriguez M, Conesa-Bertran G, Illueca-Moreno M, Llado-Carbo E, Perla Y Perla C, Garrido C, Pariente JC, Laredo C, Munoz-Moreno E, Bargallo N, Trompetto C, Marinelli L, Bartres-Faz D, Abellaneda-Perez K, Pascual-Leone A, Tormos-Munoz JM. Non-invasive prehabilitation to foster widespread fMRI cortical reorganization before brain tumor surgery: lessons from a case series. J Neurooncol. 2024 Oct;170(1):185-198. doi: 10.1007/s11060-024-04774-4. Epub 2024 Jul 23. PMID 39044115
RESULTGulrandhe P, Acharya S, Patel M, Shukla S, Kumar S. Pertinence of Constraint-Induced Movement Therapy in Neurological Rehabilitation: A Scoping Review. Cureus. 2023 Sep 13;15(9):e45192. doi: 10.7759/cureus.45192. eCollection 2023 Sep. PMID 37842361
RESULTSheng R, Chen C, Chen H, Yu P. Repetitive transcranial magnetic stimulation for stroke rehabilitation: insights into the molecular and cellular mechanisms of neuroinflammation. Front Immunol. 2023 May 22;14:1197422. doi: 10.3389/fimmu.2023.1197422. eCollection 2023. PMID 37283739
RESULTde Almeida CC, Neville IS, Hayashi CY, Gomes Dos Santos A, Brunoni AR, Teixeira MJ, Paiva WS. Quantification of tumor induced motor cortical plasticity using navigated transcranial magnetic stimulation in patients with adult-type diffuse gliomas. Front Neurosci. 2023 Mar 15;17:1143072. doi: 10.3389/fnins.2023.1143072. eCollection 2023. PMID 37008212
RESULTHamer 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
RESULTCargnelutti E, Ius T, Skrap M, Tomasino B. What do we know about pre- and postoperative plasticity in patients with glioma? A review of neuroimaging and intraoperative mapping studies. Neuroimage Clin. 2020;28:102435. doi: 10.1016/j.nicl.2020.102435. Epub 2020 Sep 14.