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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how transcranial magnetic stimulation (TMS), a non-invasive procedure using magnetic fields to stimulate nerve cells, can aid in recovering movement after brain tumor surgery. The focus is on improving motor skills that might be lost due to surgery or the tumor itself. Individuals who have had surgery to remove a brain tumor near the brain's movement control area might be suitable candidates. Participants should not be on antipsychotic medications or have a history of certain mental health conditions. As an unphased trial, this study offers a unique opportunity to contribute to pioneering research that could enhance recovery options for future patients.

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 prior data suggests that transcranial magnetic stimulation is safe for improving motor rehabilitation in brain tumor patients?

Research has shown that transcranial magnetic stimulation (TMS) is generally safe for patients. In past studies, personalized TMS proved effective and safe for individuals with thinking and memory problems following brain surgery, indicating it can address these issues without causing harm.

Another study tested TMS on patients with movement problems after brain surgery for tumors. The results were promising, suggesting it improved movement without serious side effects.

Overall, TMS is a non-invasive method, meaning it doesn't involve surgery or entering the body, which usually enhances safety. It uses magnetic fields to stimulate the brain. This technique has also been used for conditions like depression and is well-tolerated by many.

While every medical treatment can have risks, current research supports the safety of TMS for improving movement after brain tumor surgery. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Transcranial Magnetic Stimulation (TMS) is unique because it offers a non-invasive approach to treating brain tumors, which sets it apart from traditional options like surgery, chemotherapy, and radiation. Researchers are excited about TMS because it uses magnetic fields to stimulate nerve cells in the brain, potentially enhancing recovery and function without the side effects associated with more invasive treatments. This technique is particularly promising because it can be administered soon after surgery, aiming to improve outcomes and quality of life for patients with brain tumors.

What evidence suggests that transcranial magnetic stimulation is effective for improving motor rehabilitation in brain tumor patients?

Research has shown that navigated repetitive transcranial magnetic stimulation (nrTMS), which participants in this trial will receive, can improve movement in patients after brain tumor surgery. One study found that nrTMS helped people recover from muscle weakness caused by brain tumors, with patients receiving nrTMS showing better results than those who did not. Another study indicated that nrTMS might also aid in addressing cognitive issues, cancer-related fatigue, and mood problems. These findings suggest that nrTMS could be a promising method to help brain tumor patients regain movement skills and enhance their quality of life. ^{2 4 6 7 8}

Who Is on the Research Team?

Sarah Prinsloo

Principal Investigator

M.D. Anderson Cancer Center

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9208734/

Assessing the Capabilities of Transcranial Magnetic ... Transcranial magnetic stimulation is a valuable tool to enhance the safety and effectiveness of brain tumor resection, by performing a high ...

2. frontiersin.org frontiersin.org/journals/oncology/articles/10.3389/fonc.2024.1368924/full

a randomized, double-blind, sham-controlled trial Navigated repetitive transcranial magnetic stimulation improves the outcome of postsurgical paresis in glioma patients – A randomized, double-blinded trial.

3. ascopubs.org ascopubs.org/doi/10.1200/jco.2015.33.15_suppl.2042

Effectiveness of transcranial magnetic stimulation in ... Results: Remission maintained in CRT+TMS in 93.3±4.6 patients vs. 40+9.1% in the control, 2-year survival increased by 2.4 times. Rate and ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S1878747925000479

Tumor suppressive effect of low-frequency repetitive ... Repetitive transcranial magnetic stimulation (rTMS) is used as a non-invasive treatment for various diseases, and its potential application in cancer ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11751341/

Repetitive Transcranial Magnetic Stimulation: Is it an Effective ... Additionally, rTMS shows promise in improving cancer-related fatigue, anxiety, depression, and cognitive dysfunction, which can indirectly ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/36308593/

Improving quality of life post-tumor craniotomy using ... The personalized functional connectivity approach to rTMS treatment may be effective and safe for patients with post-craniotomy neuro-cognitive dysfunction.

7. nature.com nature.com/articles/s41598-020-65944-8

Navigated repetitive transcranial magnetic stimulation as ... Our findings suggest that nrTMS language mapping could be a reliable method, particularly in obtaining responses for cases without tumor-involvement.

8. mayoclinic.org mayoclinic.org/tests-procedures/transcranial-magnetic-stimulation/about/pac-20384625

Transcranial magnetic stimulation Transcranial magnetic stimulation (TMS) is a procedure that uses magnetic fields to stimulate nerve cells in the brain to improve symptoms of major depression.