rTMS for Postoperative Brain Tumor Patients
This study is testing if a treatment called repetitive Transcranial Magnetic Stimulation (rTMS) can help people who have trouble with movement after brain tumor surgery. Sometimes, surgery to remove brain tumors can unintentionally affect areas of the brain that control movement. rTMS uses magnetic pulses to stimulate specific parts of the brain. This study will treat six patients with rTMS once a day for three days in a row. The main goals are to see if rTMS is safe and practical for patients with movement difficulties after surgery. To join, you must be between 22 and 65 years old, have had brain tumor surgery, and have ongoing movement problems. The current recruitment status is unclear.
- Study design
- This is a small, single-center pilot study that will enroll 6 participants. It is not randomized and participants will know they are receiving the treatment.
- What's involved
- Participants will receive rTMS treatment for three consecutive days within a one-week period. Post-treatment assessments will occur at 1 week, 1 month, 3 months, and 6 months.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for up to 6 months after treatment.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
rTMS for Postoperative Brain Tumor Patients
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Brian J Gill, MD · PRINCIPAL_INVESTIGATOR · Columbia University
Who to contact
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What this trial measures
- Number of adverse events and serious adverse events experienced following transcranial magnetic stimulation sessionsUp 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 deficitsUp 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.