Evaluation of Therapeutic Effects of Navigation-guided 1 Hz rTMS Administered to the Contralesional Hemisphere in Patients With Stroke
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Upper Extremity Fugl-Meyer Score
研究概览
简要总结
This is a prospective randomized controlled feasibility study to determine whether navigation guided repetitive transcranial magnetic stimulation (rTMS) to the healthy hemisphere in patients with subacute stroke has a beneficial effect when given concurrently with task-oriented motor rehabilitation of the arm and hand. Navigation guided rTMS requires a structural MRI scan for targeting stimulation and therefore structural MRI will be performed on all subjects. In addition the study intends to determine whether measures of motor tract integrity (MTI) assessed by navigated brain stimulation (NBS) and MRI diffusion tensor imaging can be used to clarify prognosis of motor recovery and to monitor progress with rehabilitation. 30 subjects with ischemic or hemorrhagic stroke 3-9 months prior to enrollment and with residual upper limb hemiplegia will be randomized to receive either 1 Hz rTMS to the contralesional hemisphere for 30 minutes 3 times a week for 6 weeks along with rehabilitation therapy or sham rTMS to the contralesional hemisphere for 30 minutes 3 times a week for 6 weeks along with rehabilitation therapy. Primary outcome is improvement on the Action Research Arm Test, a measure of arm and hand function in people with stroke. Outcomes will be measured immediately post treatment, and at 3 months and 6 months post treatment.
详细描述
PRIMARY OBJECTIVES To determine whether NBS guided 1Hz rTMS targeting the motor representation areas of hand muscles on the healthy brain hemisphere has a beneficial effect on the motor recovery of the corresponding stroke-affected muscles when combined with standardized task-oriented motor rehabilitation.
SECONDARY OBJECTIVES
- To determine whether motor evoked potentials (MEPs) can be elicited from paretic and/or plegic muscles in patients with stroke using navigated TMS (eXimia NBS) and targeting the anatomical cortical areas representing the affected muscles.
- To determine the correlation between existing MEPs, other TMS parameters and the clinical deficits of limb function.
- To determine the prognostic value of MEPs and other TMS parameters in predicting motor recovery after stroke
- To determine the diagnostic value of MEPs and other TMS parameters in monitoring the response to rehabilitation
- To assess safety by capturing all Serious Adverse Events during both single pulse and rTMS delivery
STUDY PROCEDURES
The purpose of the study including risks and benefits will be explained to potential participants who will then be asked to sign an informed consent form. Potential participants will be screened for inclusion and exclusion criteria
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥ 18 years of age
- •An ischemic or hemorrhagic stroke suffered 3-9 months prior to the study
- •no other known brain abnormalities by history or by structural MRI
- •A one-sided stroke resulting in upper extremity paresis
- •A Chedoke Arm and Hand Activity Inventory score of 3-6 for the affected limb
排除标准
- •Implanted metallic parts of implanted electronic devices, including pacemakers, defibrillators, or implant medication pump
- •Pregnant or trying to become pregnant
- •History of alcohol abuse, illicit drug use or drug abuse or significant mental illness
- •any history of epilepsy
- •Any condition that would prevent the subject from giving voluntary informed consent
- •An implanted brain stimulator
- •Aneurysm clip or other metal in body
- •Enrolled or plans to enroll in an interventional trial during this study
- •Scalp wounds or infections
- •Claustrophobia precluding MRI
- •A fixed contraction deformity in the affected limb
- •Excessive spasticity as indicated by the Modified Ashworth Spasticity (MAS) Scale >2/4 in the affected limb
- •previous stroke with residual deficits (TIAs not a reason for exclusion)
- •premorbid (retrospective) modified Rankin Scale (mRS) score ≥2 of any aetiology
- •a concurrent progressive neurologic disorder, acute coronary syndrome, severe heart disease (NYHA Classification > 3), or other major medical condition
- •confirmed or suspected lower-limb fracture preventing mobilization
- •patients requiring palliative care
- •patients undergoing any other occupational therapy than what is provided in the study
- •A recent injection of botulinum toxin to the affected upper limb in the last 3 months, or the need of an injection of botulinum toxin anytime during the study period and follow up
- •Ataxia as measured by a score > 1 on item 7 (limb ataxia) of the NIH stroke scale
- •Severe aphasia as measured by a score of > 2 on item 9 (best language) of the NIH stroke scale
- •Severe neglect as measured by a score of 2 on item 11 (extinction and inattention) of the NIH stroke scale
研究组 & 干预措施
Active rTMS
Experimental subjects will receive subthreshold or suprathreshold rTMS to contralesional hemisphere for up to 20 minutes at 1 Hz followed by task oriented arm and hand therapy to affected limb.
干预措施: Repetititve transcranial magnetic stimulation (Device)
Sham rTMS
Subject will receive sham rTMS to contralesional hemisphere for up to 20 minutes followed by task-oriented arm and hand rehabilitation to affected limb
干预措施: Repetititve transcranial magnetic stimulation (Device)
结局指标
主要结局
Upper Extremity Fugl-Meyer Score
时间窗: Baseline, post treatment, 1 month, 6 months
Upper extremity Fugl-Meyer Score measures of motor impairment in hemiplegic upper limb of patients with stroke. The scoring follows the natural progression of motor recovery as defined by Twitchell (Brain. 1951; 64:443-480). The score was developed by Axel Fugl-Meyer and it has been validated (Scand J Rehab Med. 1975; 7:13-31; Stroke. 2009; 40: 1386-1391). The scale ranges 0-66 with 66 representing normal motor function and 0 representing no movement. There are 33 movement items each scored 0 (cannot perform), 1 (peforms partially), 2 (performs flawlessly)
次要结局
- Action Research Arm Test(Baseline, post treatment, 1 month, 6 months)
- Stroke Impact Scale(Baseline, post treatment, 1 month, 6 months)
- Chedoke Arm Assessment(Screening, baseline, weekly, post treatment, 1 month, 6 months)
- NIH Stroke Scale(Screening, baseline, post treatment, 1 month, 6 months)
研究者
Richard Harvey
Medical Director of Stroke Rehabilitation
Shirley Ryan AbilityLab