rTMS for Postoperative Brain Tumor Patients

Official title

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

Overview

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.

Interventions

• 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,

Primary outcome measures

• 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]

Secondary outcome measures (7)

• Motor recovery as evaluated by change from baseline in the Medical Research Council (MRC) Scale for Muscle Strength [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) [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) [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) [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 [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) [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 [Time frame: Baseline, 1 week, 1 month, 3 months, and 6 months post-intervention]

Eligibility criteria

Inclusion criteria

• 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.

Exclusion criteria

• 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.
• 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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

United States · 1 center

• Columbia University Irving Medical Center — New York

Identifiers

NCT: NCT07530536 · AAAU6372

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗