Recruiting

TMS

Sponsor:

Brian J.Gill

Code:

NCT07530536

Conditions

Brain Tumors

Transcranial Magnetic Stimulation

Motor Deficit

Quality of Life

Eligibility Criteria

Sex: All

Age: 22 - 65

Healthy Volunteers: Not accepted

Interventions

Transcranial magnetic stimulation (TMS)

Study Details

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.

Conditions

Brain Tumors

Transcranial Magnetic Stimulation

Motor Deficit

Quality of Life

Study ID

NCT07530536

Start date

Jun, 2026

Status verified date

Apr, 2026

Completion date

Apr, 2028

Anticipated

Primary completion date

Apr, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 22 - 65

Healthy Volunteers: Not accepted

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 Design

Enrollment

6 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

Interventions

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.

Primary outcome measure

  • Number of adverse events and serious adverse events experienced following transcranial magnetic stimulation sessions [ Time Frame: Up to 2 weeks ]
  • Feasibility of transcranial magnetic stimulation in postcraniotomy patients who present with either acute or chronic deficits [ Time Frame: Up to 2 weeks ]

Central Contacts and Locations

Central contacts

Locations

Columbia University Irving Medical Center

Recruiting

New York, New York, United States, 10032

Contacts

More Information

Sponsor

Brian J.Gill

Last update posted

Apr 15, 2026

Last verified

Apr, 2026

Keywords

  • Transcranial magnetic stimulation
  • Brain tumor
  • Post-operative muscle weakness
  • Quality of life
  • Brain tumor surgery
  • TMS
  • Post-craniotomy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Brian J.Gill on 2026-04-15.