rTMS for Postoperative Brain Tumor Patients

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Устройство 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,

Первичные конечные точки

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

Вторичные конечные точки (7)

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

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Columbia University Irving Medical Center — New York

Идентификаторы

NCT: NCT07530536 · AAAU6372

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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