NCT07530536

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6

participants targeted

Target at below P25 for not_applicable

Timeline
22mo left

Started Jun 2026

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 31, 2026

Completed
15 days until next milestone

First Posted

Study publicly available on registry

April 15, 2026

Completed
2 months until next milestone

Study Start

First participant enrolled

June 1, 2026

Expected
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2028

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2028

Last Updated

April 15, 2026

Status Verified

April 1, 2026

Enrollment Period

1.8 years

First QC Date

March 31, 2026

Last Update Submit

April 10, 2026

Conditions

Brain TumorsTranscranial Magnetic StimulationMotor DeficitQuality of Life

Keywords

Transcranial magnetic stimulationBrain tumorPost-operative muscle weaknessQuality of lifeBrain tumor surgeryTMSPost-craniotomy

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (7)

  • Motor recovery as evaluated by change from baseline in the Medical Research Council (MRC) Scale for Muscle Strength

    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)

    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)

    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)

    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

    Baseline, 1 week, 1 month, 3 months, and 6 months post-intervention

  • +2 more secondary outcomes

Study Arms (1)

Transcranial magnetic stimulation

EXPERIMENTAL

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)

Interventions

Transcranial magnetic stimulation (TMS)DEVICE

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.

Transcranial magnetic stimulation

Eligibility Criteria

Age22 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Columbia University Irving Medical Center

New York, New York, 10032, United States

RECRUITING

Related Links

MeSH Terms

Conditions

Brain NeoplasmsNeurologic Manifestations

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Central Nervous System NeoplasmsNervous System NeoplasmsNeoplasms by SiteNeoplasmsBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Magnetic Field TherapyTherapeutics

Study Officials

  • Brian J Gill, MD

    Columbia University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Research Nurse Navigator

CONTACT

212-342-5162cancerclinicaltrials@cumc.columbia.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assistant Professor of Neurological Surgery

Study Record Dates

First Submitted

March 31, 2026

First Posted

April 15, 2026

Study Start (Estimated)

June 1, 2026

Primary Completion (Estimated)

April 1, 2028

Study Completion (Estimated)

April 1, 2028

Last Updated

April 15, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)