NCT07530536 · Brian J.Gill
rTMS for Postoperative Brain Tumor Patients
What this study is about
When doctors perform surgery to remove brain tumors, the goal is to take out as much of the tumor as possible while keeping the patient's brain functions intact. However, sometimes patients have trouble with movements like walking or using their hands after surgery. One reason for this is unintentional damage to important areas of the brain during the operation.
View original scientific description
When doctors perform surgery to remove brain tumors, the goal is to take out as much of the tumor as possible while keeping the patient's brain functions intact. However, sometimes patients have trouble with movements like walking or using their hands after surgery. One reason for this is unintentional damage to important areas of the brain during the operation. A technique called Transcranial Magnetic Stimulation (TMS) might help patients recover these lost abilities faster. The investigators are conducting a study to see if TMS can help patients recover their movement abilities after brain tumor surgery. TMS uses magnetic pulses to stimulate specific parts of the brain. In this study, the investigators will treat six patients with TMS once per day for three days in a row. Three patients with recent movement difficulties one to two weeks after surgery will be recruited for this study; they will also receive physical therapy. An additional three patients with persisting movement difficulties up to three years after tumor surgery will also be recruited for this study, regardless of whether or not they receive physical therapy. The investigators will use two standard tests to see how well patients can move before and after the TMS treatment. These tests will help the investigators understand if TMS is making a difference in their recovery.
Interventions
DEVICE
Transcranial magnetic stimulation (TMS)
Transcranial magnetic stimulation (TMS) is a non-invasive brain stimulation technique. This intervention involves a form of repetitive TMS (rTMS) known as continuous theta burst stimulation (cTBS) to Brodmann cortical areas, which correspond to the contralesional supplementary motor area (SMA), pre-central gyrus (PrCG), and post-central gyrus (PoCG) to side of paresis and excitatory intermittent theta burst stimulation (iTBS) to Brodmann cortical areas, which correspond to the ipsilesional SMA, PrCG and PoCG.
Primary outcome measures
Number of adverse events and serious adverse events experienced following transcranial magnetic stimulation sessions
Time frame: Up to 2 weeks
Safety will be determined by the rate of adverse events that occur within one week following completion of the transcranial magnetic stimulation protocol. Adverse events (AEs) and serious adverse events (SAEs) will be reported, along with their 95% confidence intervals.
Feasibility of transcranial magnetic stimulation in postcraniotomy patients who present with either acute or chronic deficits
Time frame: Up to 2 weeks
Feasibility, as assessed by initial motor recovery, will be measured by participants' British Medical Research Council (MRC) score one week after protocol completion. For the primary feasibility endpoint, mean MRC scores will be reported before and one week after protocol completion. The MRC score ranges from 0 to 5, with a higher score indicating better muscle strength. A paired t-test will be used to determine whether the mean MRC score significantly increases after the TMS treatment. A 20-point increase is anticipated in the mean MRC score one week after protocol completion compared to before TMS treatment. Assuming a pooled standard deviation of 15 points, the test has a power of 0.87 to reject the null hypothesis with 6 evaluable patients and a significance level of 0.05.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Patients aged 22-65 years old who have undergone surgical resection for a brain tumor.
- Patients undergoing any form of prior therapy, other than previous TMS therapy, will be considered.
- Patients who present with sustained postoperative motor deficits at 1-2 weeks postoperatively as defined by the presence of British Medical Research Council (MRC) motor scores of 3/5 or less, or a sustained decrement by one point on the MRC score in the affected extremity.
- Patients who present within three years of surgery with chronic, persistent motor-functional deficits will be included to demonstrate generalizability of safety and efficacy in neurosurgery patients with chronic deficits.
- Ability to understand and the willingness to sign a written informed consent document.
Exclusion criteria
- Patients with any clinical history of seizures.
- Patients with implanted devices (e.g., pacemakers, implanted stimulators, intracranial electrodes, cochlear implants).
- Patients who have undergone a brain biopsy alone without resection.
- Patients with postoperative cognitive deficits as defined by a Mini Mental State Examination score \<26.
- History of bipolar disorder.
- Pregnant or breast-feeding individuals.
- Active suicidal ideation or plan as assessed by the Columbia Suicide Severity Rating Scale.
- History of moderate to severe heart disease.
- History of other neurological conditions defined by structural cerebral damage (e.g., stroke, multiple sclerosis, other neurodegenerative diseases, meningoencephalitis)
Where
- New York, New York
Collaborators
Columbia University
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Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Apr 15, 2026 · Source of record for eligibility and locations