An interventional study of Transcranial magnetic stimulation (TMS) in Brain Tumors, Transcranial Magnetic Stimulation and Motor Deficit, sponsored by Brian J.Gill. Recruiting at 1 site in United States. Open to participants aged 22 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-04-15.
Sponsored by Brian J.Gill · Not applicable, Interventional, and Treatment
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.
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.
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This study's planned enrollment of 6 is below the median of 40 across 1,458 interventional studies indexed under Brain Neoplasms.
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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.
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.
Time frame: 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.
Time frame: Up to 2 weeks
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline, 1 week, 1 month, 3 months, and 6 months post-intervention
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