rTMS to improve movement after brain tumor surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.