rTMS to improve movement after brain tumor surgery
Repetitive Transcranial Magnetic Stimulation for Enhancing Motor Recovery in Postoperative Brain Tumor Patients
This pilot will try whether short courses of daily TMS can help adults with new or ongoing movement weakness after brain tumor surgery recover strength and function.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 6 (estimated) |
| Ages | 22 Years to 65 Years |
| Sex | All |
| Sponsor | Columbia University Academic / other |
| Locations | 1 site (New York, New York) |
| Trial ID | NCT07530536 on ClinicalTrials.gov |
What this trial studies
This is a prospective, single-center, non-randomized open-label pilot testing repetitive TMS (rTMS) for safety and feasibility in postoperative or chronic motor deficits after brain tumor resection. Up to six adults (acute and chronic deficits) will receive three consecutive days of theta burst TMS protocols targeting ipsilesional and contralesional motor regions, with acute patients also receiving standard physiotherapy. Treatments use inhibitory continuous TBS on contralesional motor areas and excitatory intermittent TBS on ipsilesional motor areas, following published neurological TMS protocols. Participants will be followed at 1 week, 1 month, 3 months, and 6 months to record safety and motor function outcomes.
Who should consider this trial
Good fit: Adults aged 22–65 who underwent brain tumor resection and have new (1–2 weeks) or persistent (up to 3 years) postoperative motor deficits meeting the MRC criteria, can consent, and do not have a history of seizures or implanted electronic devices are the intended candidates.
Not a fit: Patients with a history of seizures or implanted devices are excluded and would not be eligible, and people whose motor loss is progressive from tumor recurrence or unrelated medical causes may not benefit from this intervention.
Why it matters
Potential benefit: If successful, the approach could speed recovery of strength and motor function after tumor surgery and improve patients' daily functioning.
How similar studies have performed: Related TMS/TBS protocols have shown promise and acceptable safety in stroke and other neurological populations and have been used in some brain tumor patients, but data specifically for postoperative tumor-related motor deficits remain limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Patients aged 22-65 years old who have undergone surgical resection for a brain tumor. 2. Patients undergoing any form of prior therapy, other than previous TMS therapy, will be considered. 3. 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. 4. 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. 5. Ability to understand and the willingness to sign a written informed consent document. Exclusion Criteria: 1. Patients with any clinical history of seizures. 2. Patients with implanted devices (e.g., pacemakers, implanted stimulators, intracranial electrodes, cochlear implants). 3. Patients who have undergone a brain biopsy alone without resection. 4. Patients with postoperative cognitive deficits as defined by a Mini Mental State Examination score \<26. 5. History of bipolar disorder. 6. Pregnant or breast-feeding individuals. 7. Active suicidal ideation or plan as assessed by the Columbia Suicide Severity Rating Scale. 8. History of moderate to severe heart disease. 9. History of other neurological conditions defined by structural cerebral damage (e.g., stroke, multiple sclerosis, other neurodegenerative diseases, meningoencephalitis)
Where this trial is running
New York, New York
- Columbia University Irving Medical Center — New York, New York, United States (Recruiting)
Study contacts
- Principal investigator: Brian J Gill, MD — Columbia University
- Study coordinator: Research Nurse Navigator
- Email: cancerclinicaltrials@cumc.columbia.edu
- Phone: 212-342-5162
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.