Brain Tumor AdultNCT07471100
Neuromodulation-Induced Cortical Prehabilitation in High Grade Glioma Near the Motor Pathway: Cortical Plasticity Assessed by Navigated Transcranial Magnetic Stimulation (nTMS)
A study testing Physical Therapy and Combined Therapy Group in people with Brain Tumor Adult and Glioma, run by Azienda Sanitaria dell'Alto Adige.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Brain Tumor Adult, Glioma, Glioma, High Grade
- What is being tested?
- Physical Therapy and Combined Therapy Group
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2026to 31 Mar 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-80
- Suspect of High Grade Glioma in MRI
- Any case of cortical/subcortical HGG radiologically close to Motor Pathway and, thus, where intraoperative monitoring assistance is usually required
- Preservation of motor function (at least ≥ 3 according to Medical Research Council classification)
- Signed informed Consent
Who cannot join
- Refusal to Study participation
- Multifocal/Bilateral Disease
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Neuromodulation-Induced-Cortical-Prehabilitation In High Grade Glioma Close To The Motor Pathway: Analysis Of The Cortical Brain Plasticity Through Navigated Transacranial Magnetic Stimulation
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:
- Does CIM (with or without rTMS) produce measurable motor-cortex plasticity from baseline to pre-surgery as assessed by neuronavigated TMS (nTMS)?
- Does adding rTMS to CIM lead to greater neuroplastic changes than CIM alone?
- What clinical, radiological, and neurophysiological outcomes are observed after surgery in participants who receive prehabilitation compared with controls?
Read more
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:
- 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)
- Undergo planned tumor surgery (according to standard methods of care) and complete postoperative clinical, imaging, and neurophysiological follow-up assessments.
Read the detailed description
Background. The Neuromodulation-Induced-Cortical-Prehabilitation (NICP) is a groundbreaking idea to promote plastic brain changes and, theoretically, to increase the Extent of Resection in brain gliomas improving the surgical outcomes. Moreover, given the infiltrative nature of brain gliomas, NICP could be consistently worthwhile for the patient's clinical outcome, reducing the likelihood of premeditated neurologic sequelae and/or the time-to-recovery during the post-surgical rehabilitation.
Hypothesis, Research Need. Up to date only small case series have analysed NICP-induced neuroplasticity, complicating data interpretation. Our study aims to thoroughly measure through neuronavigated Transcranial-Magnetic-Stimulation (nTMS) the plastic brain changes of Physical Therapy (in particular Constraint-Induced-Movements - CIM), repetitive-TMS (rTMS) and the combination of these two techniques in high-grade gliomas (HGGs) close to the motor pathway before surgery to improve surgical outcomes for the benefit of the patient.
Methodology. This is a multi-center, prospective, randomized pilot trial. The patients are randomized in 3 groups (A. Control Group, B. Physical Therapy Group, C. Physical Therapy+rTMS Group; randomization 1:2:2). The participants undergo motor cortex analysis through nTMS at the baseline - T0 - and the day before surgery - T1. Postoperative clinical, radiological and neurophyisiological outcomes are also gathered.
Patient Enrolment:
- Department of Neurosurgery, Hospital of Bolzano (SABES-ASDAA), Bolzano, Italy
- Department of Neurosurgery, Azienda Ospedaliera Universitaria Integrata (AOUI) di Verona, Italy
Data analysis:
- Department of Neurosurgery, Hospital of Bolzano (SABES-ASDAA), Bolzano, Italy
- Center for Mind/Brain Sciences - CIMEC, University of Trento, Italy
- Department of Neurorehabilitation, Hospital of Vipiteno, SABES-ASDAA), Vipiteno, Italy
Analysis Tools:
- Measurement of neuroplasticity with TMS(Nextim NBS System 5 in Bolzano/EbNeruo STM9000 in Verona). Cortical changes in motor representations will be addressed with:a) nTMS mapping of the motor cortex representations (MEP amplitude and waveforms) on individual anatomical imagesb)
- Single-pulse indexes of motor cortical excitability:
- Cortical Silent Period
- Recruitment Curve
- Resting Motor Threshold (and intehemispheric ratio)
- Dual-pulse measures of cortical excitability:
- Short-latency intracortical inhibition/facilitation
- Short-latency afferent inhibition
Expected Outcomes. The investigators don't expect any variation in cortical neuroplasticity between T0 and T1 in group A. On the contrary, The investigators expect a variation in group B, in group C and in group B vs. C.
- Conditions
- Brain Tumor Adult, Glioma, Glioma, High Grade
- Being tested
- Physical Therapy, Combined Therapy Group
- Keywords
- prehabilitation, neuromodulation, brain plasticity, cortical plasticity, rTMS, nTMS, physical therapy
- Medical subject headings
- Glioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical TherapyProcedure or surgery
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)
Combined Therapy GroupProcedure or surgery
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)
| Study group | Role | What they receive |
|---|---|---|
| Control (no NICP) | No intervention | Physical Therapy Group |
| Physical Therapy Group: patients who undergo only physical therapy | Experimental | 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) Receives: Procedure: Physical Therapy |
| Combined Therapy Group: patients who undergo physical therapy + rTMS | Experimental | 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) Receives: Procedure: Combined Therapy Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of neuroplasticity with nTMS
Cortical changes in motor representations will be addressed with Neuronavigated TMS mapping of the motor representations (MEP amplitude and waveforms) of the cortical surface of the peri-Rolandic region on individual anatomical images (Nextim NBS System 5 in Bolzano/EbNeruo STM9000 in Verona). We will consider as primary outcome variable the extension of the cortical surface from which MEPs can be obtained by neuronavigated TMS on the affected hemisphere during the procedure of neuronavigation. This index will be calculated quantitatively as surface area, on the flattened cortical surface, and on the "density" of MEP amplitude on such surface. In addition, we will carry out a quantitative analysis of how many excitable points are present in different cortical regions, by applying the cortical atlas by Glasser et al. (2016) to the patient's brain. In this way we will also be able to quantify the extension of excitable points to the premotor or even non-motor cortical regions.
Measured: From the date of randomization until the date of surgery, assessed up to 15 days
Measurement of neuroplasticity with TMS
- Single-pulse indexes of motor cortical excitability (unit of measure milli Volt - mV):
- Cortical Silent Period (CSP)
- Recruitment (input-output) Curve (RC)
- Resting Motor Threshold (rMT) and intehemispheric rMT ratio (rMT ratio)
- Dual-pulse measures of cortical excitability (Adimensional; they are MEP-derived ratios . MEP amplitudes are measured in mV).):
- Short-latency intracortical inhibition/facilitation (SICI and SICF)
- Short-latency afferent inhibition (SAI)
Measured: From the date of randomization until the date of surgery, assessed up to 15 days
Secondary outcomes (2)
Measurement of neuroplasticity with TMS (after surgery)
Cortical changes in motor representations will be addressed with:
Neuronavigated TMS mapping of the motor representations (MEP amplitude and waveforms) of the cortical surface of the peri-Rolandic region on individual anatomical images (Nextim NBS System 5 in Bolzano/EbNeruo STM9000 in Verona)
Measured: At 1 month and 3 months after surgery
Measurement of neuroplasticity with TMS
- Single-pulse indexes of motor cortical excitability (measured in mV): Cortical Silent Period (CSP) Recruitment (input-output) Curve (RC) Resting Motor Threshold (rMT) and intehemispheric rMT ratio (rMT ratio)
- Dual-pulse measures of cortical excitability (Adimensional; they are MEP-derived ratios - MEP amplitudes are measured in mV):
Short-latency intracortical inhibition/facilitation (SICI and SICF) Short-latency afferent inhibition (SAI)
Measured: At 1 month and 3 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2026
- Study start1 Apr 2026 (estimated)
- Primary completion31 Mar 2028 (estimated)
- Study completion31 Mar 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Brain Tumor AdultStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a multi-center, prospective, randomized pilot trial. The patients are randomized in 3 groups (eandomization 1:2:2): A. Control Group, B. Physical Therapy Group, C. Physical Therapy+rTMS Group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 63 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Azienda Sanitaria dell'Alto Adige
- Sponsor type
- University, hospital or other
- Collaborators
- Università degli Studi di Trento, Azienda Ospedaliera Universitaria Integrata Verona
- Responsible party
- Principal investigator, Pier Paolo Berti, Azienda Sanitaria dell'Alto Adige
- Investigators
- Pier Paolo Berti, MD, Principal investigator, Department of Neurosurgery, Hospital of Bolzano (SABES-ASDAA) - L. Boehler street n5 Bolzano, BZ, Italy 39100
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07471100
- Sponsor's protocol ID
- Protocol n.4/2024 bis
- Status last verified
- Mar 2026
- First submitted
- 2 Mar 2026
- Last updated
- 13 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified IPD necessary to reproduce the primary and secondary analyses, including variables used in the statistical models (baseline characteristics, key covariates, endpoints, and safety outcomes), together with the data dictionary and statistical code. Data not required for the planned analyses and variables posing an increased re-identification risk will not be shared.
Publications
Boccuni 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.
PubMed 39044115Gulrandhe 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.
PubMed 37842361Sheng 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.
PubMed 37283739de 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.
PubMed 37008212Hamer 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.
PubMed 35454957Cargnelutti 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.
PubMed 32980599
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neuromodulation-Induced-Cortical-Prehabilitation In High Grade Glioma Close To The Motor Pathway: Analysis Of The Cortical Brain Plasticity Through Navigated Transacranial Magnetic Stimulation
- ClinicalTrials.gov ID
- NCT07471100
- Acronym / sponsor ID
- Protocol n.4/2024 bis
- Conditions
- Brain Tumor Adult, Glioma, Glioma, High Grade
- Keywords
- prehabilitation, neuromodulation, brain plasticity, cortical plasticity, rTMS, nTMS, physical therapy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 63 participants (estimated)
- Lead sponsor
- Azienda Sanitaria dell'Alto AdigeUniversity, hospital or other
- Collaborators
- Università degli Studi di Trento, Azienda Ospedaliera Universitaria Integrata Verona
- Study start
- 1 Apr 2026 (estimated)
- Primary completion
- 31 Mar 2028 (estimated)
- Study completion
- 31 Mar 2030 (estimated)
- First posted
- 13 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Does CIM (with or without rTMS) produce measurable motor-cortex plasticity from baseline to pre-surgery as assessed by neuronavigated TMS (nTMS)?
- Does adding rTMS to CIM lead to greater neuroplastic changes than CIM alone?
- 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:
- 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)
- Undergo planned tumor surgery (according to standard methods of care) and complete postoperative clinical, imaging, and neurophysiological follow-up assessments.
Detailed description
Background. The Neuromodulation-Induced-Cortical-Prehabilitation (NICP) is a groundbreaking idea to promote plastic brain changes and, theoretically, to increase the Extent of Resection in brain gliomas improving the surgical outcomes. Moreover, given the infiltrative nature of brain gliomas, NICP could be consistently worthwhile for the patient's clinical outcome, reducing the likelihood of premeditated neurologic sequelae and/or the time-to-recovery during the post-surgical rehabilitation.
Hypothesis, Research Need. Up to date only small case series have analysed NICP-induced neuroplasticity, complicating data interpretation. Our study aims to thoroughly measure through neuronavigated Transcranial-Magnetic-Stimulation (nTMS) the plastic brain changes of Physical Therapy (in particular Constraint-Induced-Movements - CIM), repetitive-TMS (rTMS) and the combination of these two techniques in high-grade gliomas (HGGs) close to the motor pathway before surgery to improve surgical outcomes for the benefit of the patient.
Methodology. This is a multi-center, prospective, randomized pilot trial. The patients are randomized in 3 groups (A. Control Group, B. Physical Therapy Group, C. Physical Therapy+rTMS Group; randomization 1:2:2). The participants undergo motor cortex analysis through nTMS at the baseline - T0 - and the day before surgery - T1. Postoperative clinical, radiological and neurophyisiological outcomes are also gathered.
Patient Enrolment:
- Department of Neurosurgery, Hospital of Bolzano (SABES-ASDAA), Bolzano, Italy
- Department of Neurosurgery, Azienda Ospedaliera Universitaria Integrata (AOUI) di Verona, Italy
Data analysis:
- Department of Neurosurgery, Hospital of Bolzano (SABES-ASDAA), Bolzano, Italy
- Center for Mind/Brain Sciences - CIMEC, University of Trento, Italy
- Department of Neurorehabilitation, Hospital of Vipiteno, SABES-ASDAA), Vipiteno, Italy
Analysis Tools:
- Measurement of neuroplasticity with TMS(Nextim NBS System 5 in Bolzano/EbNeruo STM9000 in Verona). Cortical changes in motor representations will be addressed with:a) nTMS mapping of the motor cortex representations (MEP amplitude and waveforms) on individual anatomical imagesb)
- Single-pulse indexes of motor cortical excitability:
- Cortical Silent Period
- Recruitment Curve
- Resting Motor Threshold (and intehemispheric ratio)
- Dual-pulse measures of cortical excitability:
- Short-latency intracortical inhibition/facilitation
- Short-latency afferent inhibition
Expected Outcomes. The investigators don't expect any variation in cortical neuroplasticity between T0 and T1 in group A. On the contrary, The investigators expect a variation in group B, in group C and in group B vs. C.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- This is a multi-center, prospective, randomized pilot trial. The patients are randomized in 3 groups (eandomization 1:2:2): A. Control Group, B. Physical Therapy Group, C. Physical Therapy+rTMS Group
| Arm | Type | Receives |
|---|---|---|
| Control (no NICP) | No intervention | –Physical Therapy Group |
| Physical Therapy Group: patients who undergo only physical therapy | Experimental | Procedure: Physical TherapyPhysical 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) |
| Combined Therapy Group: patients who undergo physical therapy + rTMS | Experimental | Procedure: Combined Therapy GroupRepetitive 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) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 18-80
- Suspect of High Grade Glioma in MRI
- Any case of cortical/subcortical HGG radiologically close to Motor Pathway and, thus, where intraoperative monitoring assistance is usually required
- Preservation of motor function (at least ≥ 3 according to Medical Research Council classification)
- Signed informed Consent
Key exclusion criteria (2 listed)
- Refusal to Study participation
- Multifocal/Bilateral Disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physical TherapyPhysical 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) | Procedure or surgery | Physical Therapy Group: patients who undergo only physical therapy |
| Combined Therapy GroupRepetitive 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) | Procedure or surgery | Combined Therapy Group: patients who undergo physical therapy + rTMS |
Primary outcome
Measurement of neuroplasticity with nTMS
Time frame: From the date of randomization until the date of surgery, assessed up to 15 days
Cortical changes in motor representations will be addressed with Neuronavigated TMS mapping of the motor representations (MEP amplitude and waveforms) of the cortical surface of the peri-Rolandic region on individual anatomical images (Nextim NBS System 5 in Bolzano/EbNeruo STM9000 in Verona). We will consider as primary outcome variable the extension of the cortical surface from which MEPs can be obtained by neuronavigated TMS on the affected hemisphere during the procedure of neuronavigation. This index will be calculated quantitatively as surface area, on the flattened cortical surface, and on the "density" of MEP amplitude on such surface. In addition, we will carry out a quantitative analysis of how many excitable points are present in different cortical regions, by applying the cortical atlas by Glasser et al. (2016) to the patient's brain. In this way we will also be able to quantify the extension of excitable points to the premotor or even non-motor cortical regions.
Measurement of neuroplasticity with TMS
Time frame: From the date of randomization until the date of surgery, assessed up to 15 days
1. Single-pulse indexes of motor cortical excitability (unit of measure milli Volt - mV): * Cortical Silent Period (CSP) * Recruitment (input-output) Curve (RC) * Resting Motor Threshold (rMT) and intehemispheric rMT ratio (rMT ratio) 2. Dual-pulse measures of cortical excitability (Adimensional; they are MEP-derived ratios . MEP amplitudes are measured in mV).): * Short-latency intracortical inhibition/facilitation (SICI and SICF) * Short-latency afferent inhibition (SAI)
2 secondary outcomes
Measurement of neuroplasticity with TMS (after surgery)
Time frame: At 1 month and 3 months after surgery
Measurement of neuroplasticity with TMS
Time frame: At 1 month and 3 months after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2026.
- Results publication: PubMed 39044115Boccuni 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.
- Results publication: PubMed 37842361Gulrandhe 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.
- Results publication: PubMed 37283739Sheng 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.
- Results publication: PubMed 37008212de 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.
- Results publication: PubMed 35454957Hamer 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.
- Results publication: PubMed 32980599Cargnelutti 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.
- Individual participant dataSharing planned: Yes. De-identified IPD necessary to reproduce the primary and secondary analyses, including variables used in the statistical models (baseline characteristics, key covariates, endpoints, and safety outcomes), together with the data dictionary and statistical code. Data not required for the planned analyses and variables posing an increased re-identification risk will not be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Pier Paolo Berti, MD principal investigator
Department of Neurosurgery, Hospital of Bolzano (SABES-ASDAA) - L. Boehler street n5 Bolzano, BZ, Italy 39100
Questions about this trial
What is this clinical trial studying?
A study testing Physical Therapy and Combined Therapy Group in people with Brain Tumor Adult and Glioma, run by Azienda Sanitaria dell'Alto Adige.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 13 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Pier Paolo Berti, MD, PhD(c) (+39 0471439716, pierpaolo.berti@sabes.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measurement of neuroplasticity with nTMS (time frame: From the date of randomization until the date of surgery, assessed up to 15 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07471100, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2026.