Utility of repetitive transcranial magnetic stimulation on functional outcomes in patients with intracranial mass lesion and postoperative hemiparesis undergoing rehabilitation
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- Primary measures-
研究概览
简要总结
Intracranial masses vary widely in severity, ranging from life-threatening lesions resistant to aggressive treatments to benign growths that only need occasional monitoring. Following surgery for primary brain tumors, it is not uncommon to observe a decline in neurological function. This deterioration can be attributed to various factors, such as perioperative ischemic injury, surgery in critical areas resulting in corresponding deficits, or the occurrence of supplementary motor area (SMA) syndrome subsequent to surgery in the premotor cortex. Consequently, enhancing the neurorehabilitation of emerging deficits holds significant promise for elevating the quality of life for these patients.
Hypothesis:
Patients with new onset postoperative hemiparesis following surgical resection of intracranial mass lesion undergoing repetitive transcranial magnetic stimulation with comprehensive inpatient rehabilitation for 12 sessions will demonstrate better progress in motor and functional status as compared to those who undergo comprehensive inpatient rehabilitation alone.
Rationale of the study: Transcranial Magnetic Stimulation [rTMS] along with rehabilitation has demonstrated positive effects on motor and functional recovery following loss of blood supply to the brain. Individuals with intracranial mass lesions may have hemiparesis as a sequelae, the beneficial effects (if any) of rTMS in this population is not clear. This study compares the functional recovery of individuals presenting with post-op (surgical resection of intracranial mass lesion) hemiparesis undergoing the standard of care i.e. in-patient rehabilitation with transcranial magnetic stimulation and the outcomes in individuals who undergo in-patient rehabilitation only.
This is a Prospective interventional trial . Participants will be screened for the above inclusion and exclusion criteria (mentioned already) following which the participants who are willing to give an informed consent will be recruited.
Patients will be divided into an age matched control group and an intervention group to receive in-patient rehabilitation (standard of care) or in-patient rehabilitation with additional rTMS sessions (1Hz, 120% RMT, 1200 pulses, 20minutes, 12 sessions) respectively. All participants shall receive an individualized in-patient rehabilitation program with a goal of improving functional status. This will consist of cognitive assessment and therapy, physiotherapy, occupational therapy, psychosocial assessment & strategies. Participants in the rTMS group will undergo additional 20 minutes of low frequency rTMS applied to the M1 area in the unaffected hemisphere to suppress its excitability.
Study Duration: 18 Months.
Frequency: 5-6 sessions per week , total of 12 sessions.
Sample size: 22 (11 in control group, 11 in intervention group)
Randomization: No
**Description of the device:**Repetitive transcranial magnetic stimulation will be performed by a single investigator, using a MagVenture MagPro R100 stimulator equipped with a liquid-cooled figure-of-eight coil (each loop 70 mm in diameter). The coil would be angled 45 degrees to the sagittal plane, with the handle pointing backwards, to ensure optimal stimulus delivery. The coil would be systematically moved around the scalp and pulses would be delivered while noting the movements of the first dorsal interosseus muscle (FDI). Magnetic stimulation will be applied at 120% of the resting motor threshold (rMT) at 1 Hz frequency. A total of 1200 pulses will be generated during each session. Dosing parameters are based on previous studies. Each session will be of 20minutes and each subject will receive 12 once daily rTMS session for 5-6 days per week.
The outcome measures (mentioned already) will be recorded at baseline (Day 0), midpoint (session 12) and the endpoint (at 3 months follow up). Monitoring for adverse events will be done throughout the study period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •a)Subject is ≥ 18 and ≤ 65 years old at the time of enrollment.
- •b)Operated patients with intracranial mass lesion presenting with hemiparesis persisting for atleast 1 week following surgical resection of the tumor.
- •c)Patients with modified Rankin Scale mRS scores between 2-5 at the time of recruitment.
- •d)Subject or his/her relative has been informed of the nature of the study, can understand the requirements of the study, agrees to participate, and is willing to give an informed consent.
排除标准
- •a)Patients with intracranial mass lesion presenting with focal motor deficits preoperatively b)Contraindications to rTMS, such as presence of metallic implants anywhere in the head, excluding the mouth, individuals with cardiac pacemakers, implanted medication pumps and patients with intracardiac lines.
- •c)Persons with serious heart disease (CAD, arrythmias, valvular lesions, congenital heart diseases, cardiomyopathy, pericardial diseases) who are at increased risk in the event of a seizure.
- •d)Patients with persisting seizures (2 or more) per week in the post operative period.
- •e)Patients with global aphasia.
- •f)Hemodynamically unstable patients requiring ICU monitoring.
- •g)Recurrent intracranial tumors.
- •h)Pregnancy.
结局指标
主要结局
Primary measures-
时间窗: Baseline- day 0 | Midpoint- after 12 sessions of therapy | Endpoint- at 3 months follow up
Motor component of Fugl Meyer
时间窗: Baseline- day 0 | Midpoint- after 12 sessions of therapy | Endpoint- at 3 months follow up
scale
时间窗: Baseline- day 0 | Midpoint- after 12 sessions of therapy | Endpoint- at 3 months follow up
次要结局
- 1. Modified Rankin scale(2. Functional ambulation classification)
研究者
Dr Anupam Gupta
National Institute of Mental Health and Neurosciences