rTMS for Postoperative Brain Tumor Patients
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age22-65
SponsorBrian J.Gill
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Single group
Treatments tested in this trial
Transcranial magnetic stimulation (TMS)
DeviceTranscranial 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.
Treatment groups
6 Participants
are divided into 1 treatment groupGroup A: Transcranial magnetic stimulationExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
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.
Time frame
Up to 2 weeks2
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 weeksSecondary outcomes
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.
Time frame
Baseline, 1 week, 1 month, 3 months, and 6 months post-intervention2
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-intervention3
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-intervention4
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-interventionSponsors and contacts
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Source ClinicalTrials.gov