Transcranial Magnetic Stimulation for Brain Tumors

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: M.D. Anderson Cancer Center

Must not be taking: Antipsychotics

Disqualifiers: Bipolar, Schizophrenia, Stroke, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 10

Duration: 3 weeks

32 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial studies how well navigated repetitive transcranial magnetic stimulation works in improving motor rehabilitation in participants with brain tumors. Navigated repetitive transcranial magnetic stimulation may help improve patients' lost motor function after surgery.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are taking any antipsychotic medications.

What data supports the effectiveness of this treatment?

Research shows that transcranial magnetic stimulation (TMS) can help improve outcomes in brain tumor patients by better identifying important brain areas during surgery. Additionally, repetitive TMS (rTMS) has been found to aid in motor recovery after strokes, suggesting it may have beneficial effects on brain function. ^{1 2 3 4 5}

How is the treatment Transcranial Magnetic Stimulation (rTMS) unique for brain tumors?

Transcranial Magnetic Stimulation (rTMS) is unique because it is a non-invasive and painless method that uses magnetic fields to stimulate specific areas of the brain, which is different from traditional treatments like surgery or radiation. It offers a novel approach by potentially preventing and treating brain injuries caused by radiation, and it can also be used for brain mapping to assist in surgeries for brain tumors. ^{4 6 7 8 9}

Research Team

Sarah Prinsloo

Principal Investigator

M.D. Anderson Cancer Center

Eligibility Criteria

This trial is for individuals with brain tumors affecting motor function, who have had recent surgery related to the motor cortex. Participants must be able to understand English, consent in writing, and follow the study's procedures. They should not be on antipsychotic meds or have a history of stroke or severe psychiatric conditions like bipolar disorder or schizophrenia.

Inclusion Criteria

Understand and read English, sign a written informed consent, and be willing to follow protocol requirements

My surgeon will decide if I can have nrTMS treatment based on my motor skills after surgery.

I had surgery near the brain's movement control area within the last week.

Exclusion Criteria

You have been diagnosed with bipolar disorder or schizophrenia in the past.

I am currently taking antipsychotic medication.

I have had a stroke in the past.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants undergo 10 sessions of navigated repetitive transcranial magnetic stimulation (nrTMS) over 3 weeks

3 weeks

10 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

3 months

Treatment Details

Interventions

• Questionnaire Administration
• Transcranial Magnetic Stimulation

Trial Overview The trial is examining how well navigated repetitive transcranial magnetic stimulation (nrTMS) can help improve movement abilities that were lost due to brain tumor surgery. Patients will receive nrTMS sessions and their motor rehabilitation progress will be monitored.

Participant Groups

Group I: Supportive care (nrTMS) Experimental Treatment 2 Interventions

Between 1-7 days after standard of care surgery, participants undergo 10 nrTMS sessions over 30 minutes each over 3 weeks.

Transcranial Magnetic Stimulation is already approved in United States, Canada, European Union for the following indications:

Approved in United States as Transcranial Magnetic Stimulation for:

• Major Depressive Disorder
• Obsessive Compulsive Disorder

Approved in Canada as Transcranial Magnetic Stimulation for:

• Major Depressive Disorder

Approved in European Union as Transcranial Magnetic Stimulation for:

• Major Depressive Disorder

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Findings from Research

Repetitive transcranial magnetic stimulation (rTMS) significantly improved motor function in stroke patients within the first month after treatment, particularly in upper limb function, as shown by various motor functional scores assessed over time.

The benefits of rTMS on upper extremity function were observed to last for up to one year, indicating its potential as a long-term therapeutic intervention for motor recovery after stroke.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of repetitive transcranial magnetic stimulation (rTMS) after acute stroke: A one-year longitudinal randomized trial. Guan, YZ., Li, J., Zhang, XW., et al.[2021]

Repetitive magnetic stimulation (rTMS) is a non-invasive and painless technique that can effectively activate specific areas of the brain, making it useful for studying language, memory, and visual perception.

rTMS shows potential therapeutic benefits for conditions like movement disorders and depression, but there are safety considerations regarding its potential to induce seizures, which are addressed in the study.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Repetitive transcranial magnetic stimulation. Possibilities, limits and safety aspects]. Brandt, SA., Ploner, CJ., Meyer, BU.[2019]

High-frequency rTMS (20 and 25 Hz) applied to the motor cortex of chronic stroke patients may increase the risk of seizures, as indicated by EMG bursts and muscle excitation observed during the study.

Despite the safety concerns, the study found no significant increase in motor cortex excitability or improvement in hand strength after rTMS, suggesting that the stimulation parameters used may not be effective for rehabilitation in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety study of high-frequency transcranial magnetic stimulation in patients with chronic stroke. Lomarev, MP., Kim, DY., Richardson, SP., et al.[2016]

References

1. England pubmed.ncbi.nlm.nih.gov

Navigated transcranial magnetic stimulation improves the treatment outcome in patients with brain tumors in motor eloquent locations. [2021]

2. England pubmed.ncbi.nlm.nih.gov

The effect and optimal parameters of repetitive transcranial magnetic stimulation on motor recovery in stroke patients: a systematic review and meta-analysis of randomized controlled trials. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Effectiveness of repetitive transcranial magnetic stimulation (rTMS) after acute stroke: A one-year longitudinal randomized trial. [2021]

4. England pubmed.ncbi.nlm.nih.gov

The preventive and therapeutic effect of repetitive transcranial magnetic stimulation on radiation-induced brain injury in mice. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Preconditioning of the motor network with repetitive navigated transcranial magnetic stimulation (rnTMS) to improve oncological and functional outcome in brain tumor surgery: a study protocol for a randomized, sham-controlled, triple-blind clinical trial. [2023]

6. Germany pubmed.ncbi.nlm.nih.gov

[Repetitive transcranial magnetic stimulation. Possibilities, limits and safety aspects]. [2019]

7. Netherlands pubmed.ncbi.nlm.nih.gov

Safety study of high-frequency transcranial magnetic stimulation in patients with chronic stroke. [2016]

8. United States pubmed.ncbi.nlm.nih.gov

Ipsilateral motor activation in patients with cerebral gliomas. [2019]

9. New Zealand pubmed.ncbi.nlm.nih.gov

Cortical mapping with navigated transcranial magnetic stimulation in low-grade glioma surgery. [2021]