rTMS for Postoperative Brain Tumor Patients

Repetitive Transcranial Magnetic Stimulation for Enhancing Motor Recovery in Postoperative Brain Tumor Patients

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.

Study Overview

• Status: Recruiting
• Conditions: Quality of Life; Transcranial Magnetic Stimulation; Brain Tumors; Motor Deficit
• Intervention / Treatment: Device: Transcranial magnetic stimulation (TMS)

Detailed Description

This study is a prospective single-center non-randomized open label pilot trial to assess the safety and feasibility of rTMS for brain tumor patients with acute or chronic post-operative motor deficits. The study will prospectively enroll 3 patients for postoperative TMS. Each treatment period will consist of 1 week, including 3 consecutive days of treatment within this week. Participants will receive inhibitory 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. This treatment will be performed for 3 consecutive days in conjunction with and without standard-of-care physiotherapy for patients with acute post-operative motor deficits and chronic post-operative motor deficits, respectively. TMS treatment protocols will include those which have already been established in the literature and validated for use in neurological patients, including those with brain tumors, with adaptations in other clinics as well. These protocols have been shown to have a significant safety profile. Post-treatment assessments will occur at 1 week, 1 month, 3 months and 6 months. Follow-up assessments will occur through patient visits, which may include standard-of-care visits for patients in the acute post-operative setting.

• Study Type: Interventional
• Enrollment (Estimated): 6
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Research Nurse Navigator; Phone Number: 212-342-5162; Email: cancerclinicaltrials@cumc.columbia.edu

Study Locations

• United States
  • New York
    • New York, New York, United States, 10032
      • Recruiting
      • Columbia University Irving Medical Center
      • Contact: Brian J Gill, MD; Phone Number: 212-305-7346; Email: bjg2140@cumc.columbia.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Transcranial magnetic stimulation; Non-invasive neuromodulation will be applied using image-guided repetitive transcranial magnetic stimulation (rTMS) with a stereotactic device. Three patients with acute motor deficits one to two weeks after surgery will also be enrolled in active rehabilitation. Three patients with persistent, chronic functional deficits for up to three years after tumor surgery will be enrolled in treatment with or without active rehabilitation. All patients will receive treatment once per day for three consecutive days. Patients will receive inhibitory 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.

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of adverse events and serious adverse events experienced following transcranial magnetic stimulation sessions	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.	Up to 2 weeks
Feasibility of transcranial magnetic stimulation in postcraniotomy patients who present with either acute or chronic deficits	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.	Up to 2 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Motor recovery as evaluated by change from baseline in the Medical Research Council (MRC) Scale for Muscle Strength	Efficacy of transcranial magnetic stimulation on motor recovery as assessed by change from baseline in the Medical Research Council (MRC) Scale for Muscle Strength. The MRC Scale ranges from Grade 0 (no visible contraction) to Grade 5 (normal muscle strength), with a higher score indicating better muscle strength. Scores will be recorded pre-intervention and then at 1 week, 1 month, 3 months, and 6 months post-intervention.	Baseline, 1 week, 1 month, 3 months, and 6 months post-intervention
Motor recovery as evaluated by change from baseline in the 10-Meter Walk Test (10MWT)	Efficacy of transcranial magnetic stimulation on motor recovery as assessed by change from baseline in The 10-Meter Walk Test (10MWT). The 10MWT measures short-distance walking speed in meters/second over a distance of six meters. Higher speeds indicate better functional mobility, vestibular function, and gait. Scores will be recorded pre-intervention and then at 1 week, 1 month, 3 months, and 6 months post-intervention.	Baseline, 1 week, 1 month, 3 months, and 6 months post-intervention
Motor recovery as evaluated by change from baseline in The Box and Block Test (BBT)	Efficacy of transcranial magnetic stimulation on motor recovery as assessed by change from baseline in the Box and Block Test (BBT). The BBT measures unilateral gross manual dexterity and is scored based upon the number of blocks a participant can transfer from one compartment of a box to another compartment within 60 seconds. Higher scores indicate better motor function in gross manual dexterity. Scores will be recorded pre-intervention and then at 1 week, 1 month, 3 months, and 6 months post-intervention.	Baseline, 1 week, 1 month, 3 months, and 6 months post-intervention
Motor recovery as evaluated by change from baseline in the Barthel Index (BI)	Efficacy of transcranial magnetic stimulation on motor recovery as assessed by change from baseline in the Barthel Index (BI). The BI measures ability to perform activities of daily living (ADLs) and mobility on a ten-item scale: (1) feeding, (2) bathing, (3) grooming, (4) dressing, (5) bowel continence, (6) bladder continence, (7) toilet use, (8) transfers from bed to chair and back, (9) mobility on level surfaces, and (10) mobility on stairs. The total score range is 0 to 100 across all 10 domains, with lower scores indicating greater dependency or impaired functional status. Scores will be recorded pre-intervention and then at 1 week, 1 month, 3 months, and 6 months post-intervention.	Baseline, 1 week, 1 month, 3 months, and 6 months post-intervention
Quality of life as evaluated by change from baseline in the QLQ-BN20	Efficacy of transcranial magnetic stimulation on quality of life as assessed by change from baseline in the QLQ-BN20 questionnaire. The QLQ-BN20 is a quality-of-life survey validated for use in patients with brain tumors. The QLQ-BN20 consists of four multi-item scales: (1) future uncertainty (four items), (2) visual disorder (three items), (3) motor dysfunction (three items), and (4) communication deficit (three items). All items and scale scores are linearly transformed onto a 0 to 100-point scale, with higher scores signifying more severe symptoms and lower quality of life. Scores will be recorded pre-intervention and then at 1 week, 1 month, 3 months, and 6 months post-intervention.	Baseline, 1 week, 1 month, 3 months, and 6 months post-intervention
Quality of life as evaluated by change from baseline in the Functional Assessment of Cancer Therapy - Brain (FACT-Br)	Efficacy of transcranial magnetic stimulation on quality of life as assessed by change from baseline in the Functional Assessment of Cancer Therapy - Brain (FACT-Br). The FACT-Br consists of the core FACT-General (FACT-G) questionnaire assessing more general domains of quality-of-life in addition to the brain tumor-specific scale. A total of 50 items is included across the following subscales: (1) physical well-being, (2) social/family wellbeing, (3) emotional well-being, (4) functional well-being, and (5) disease-specific concerns. Participants indicate the presence/severity of symptoms on a 5-point Likert Scale (0 to 4), with higher scores indicating more present/severe symptoms and lower quality of life. The total score range is 0 to 200. Scores will be recorded pre-intervention and then at 1 week, 1 month, 3 months, and 6 months post-intervention.	Baseline, 1 week, 1 month, 3 months, and 6 months post-intervention
Quality of life as evaluated by change from baseline in the EQ-5D-5L	Efficacy of transcranial magnetic stimulation on quality of life as assessed by change from baseline in the EQ-5D-5L. The EQ-5D-5L is a validated instrument that assesses quality of life using self-reported profile data and a subjective visual scale to capture participants' perceptions of their own health. The EQ-5D-5L profile data is measured across five dimensions: (1) mobility, (2) usual activities, (3) self-care, (4) pain and discomfort, and (5) anxiety and depression. Each dimension is measured on a 5-point Likert scale, with 1 indicating no issues in a particular domain and 5 indicating extreme issues. Scores across all five dimensions form a five-digit "value set," which are then converted to a single number (i.e., EQ-5D values) using a weighting system. The total score ranges from 0 (indicating death) to 1 (indicating full health). Scores will be recorded pre-intervention and then at 1 week, 1 month, 3 months, and 6 months post-intervention.	Baseline, 1 week, 1 month, 3 months, and 6 months post-intervention

Collaborators and Investigators

• Sponsor: Brian J.Gill
• Collaborators: Columbia University
• Investigators: Principal Investigator: Brian J Gill, MD, Columbia University

Publications and helpful links

Helpful Links

• Evaluating the safety profile of connectome-based repetitive transcranial magnetic stimulation
• Transcranial magnetic stimulation for post-operative neurorehabilitation in neuro-oncology: a review of the literature and future directions
• Interventional neurorehabilitation for promoting functional recovery post-craniotomy: a proof-of-concept

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): April 1, 2028
• Study Completion (Estimated): April 1, 2028

Study Registration Dates

• First Submitted: March 31, 2026
• First Submitted That Met QC Criteria: April 10, 2026
• First Posted (Actual): April 15, 2026

Study Record Updates

• Last Update Posted (Actual): April 15, 2026
• Last Update Submitted That Met QC Criteria: April 10, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Quality of life; Brain tumor; Transcranial magnetic stimulation; TMS; Post-craniotomy; Post-operative muscle weakness; Brain tumor surgery
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neoplasms by Site; Neoplasms; Nervous System Neoplasms; Central Nervous System Neoplasms; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Neurologic Manifestations; Brain Neoplasms; Therapeutics; Magnetic Field Therapy; Transcranial Magnetic Stimulation
• Other Study ID Numbers: AAAU6372

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes