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Brain TumorsNCT07530536

rTMS for Postoperative Brain Tumor Patients

A study testing Transcranial magnetic stimulation (TMS) in people with Brain Tumors and Transcranial Magnetic Stimulation, run by Brian J.Gill at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 22 to 65 years
What is being tested?
Transcranial magnetic stimulation (TMS)
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
6 participants
Where
1 siteUnited States
Study dates
Jun 2026to Apr 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 22 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 9Show fewer
  • 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)

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

United States1 site, 1 recruiting
  • Columbia University Irving Medical Center

    New York, New York, 10032

    Brian J Gill, MD, 212-305-7346, bjg2140@cumc.columbia.edu

    Recruiting

Other trials in United States

About this study

Official title: 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.

Read the 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.

Being tested
Transcranial magnetic stimulation (TMS)
Keywords
Transcranial magnetic stimulation, Brain tumor, Post-operative muscle weakness, Quality of life, Brain tumor surgery, TMS, Post-craniotomy
Medical subject headings
Brain Neoplasms, Neurologic Manifestations

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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.

Study groups in NCT07530536
Study groupRoleWhat they receive
Transcranial magnetic stimulationExperimentalNon-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.
Receives: Device: Transcranial magnetic stimulation (TMS)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Up to 2 weeks

  2. 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.

    Measured: Up to 2 weeks

Secondary outcomes (7)
  1. 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.

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

  2. 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.

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

  3. 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.

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

  4. 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.

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

  5. 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.

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

  6. 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.

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

  7. 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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Apr 2026
  2. Study startJun 2026 (estimated)
  3. Primary completionApr 2028 (estimated)
  4. Study completionApr 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
6 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07530536
Sponsor's protocol ID
AAAU6372
Status last verified
Apr 2026
First submitted
31 Mar 2026
Last updated
15 Apr 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Transcranial magnetic stimulation (TMS) in people with Brain Tumors and Transcranial Magnetic Stimulation, run by Brian J.Gill at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 15 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Research Nurse Navigator (212-342-5162, cancerclinicaltrials@cumc.columbia.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of adverse events and serious adverse events experienced following transcranial magnetic stimulation sessions (time frame: Up to 2 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2026.

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