NCT07530536

rTMS for Postoperative Brain Tumor Patients

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 6 (estimated)
• Sponsor: Brian J.Gill · Academic / Other
• Sex: All
• Age: 22 Years – 65 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Brain Tumors
• Transcranial Magnetic Stimulation
• Motor Deficit
• Quality of Life

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2026-06-01
• Primary completion: 2028-04-01
• Completion: 2028-04-01
• First posted: 2026-04-15
• Last updated: 2026-04-15

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study