Neurotech PD Gait: Multisite Non-invasive Electrical Stimulation to Optimize Motor-cognitive Rehabilitation Response in Parkinson's Disease Subjects With Postural Instability and Gait Disorders
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 71
- 试验地点
- 2
- 主要终点
- Total execution time of Timed Up and Go test with cognitive dual-task (TUG-COG)
研究概览
简要总结
The trial will include 51 adult participants with Parkinson's disease and postural instability and gait disorders (PD-PIGD) and 20 age- and sex-matched healthy controls.
At baseline (T0) patients will undergo neurological and cognitive/behavioural assessments, gait/balance evaluation, neuroimaging/neurophysiology assessments including brain magnetic resonance imaging (MRI), functional Near Infrared Spectroscopy (fNIRS) and Electroencephalography (EEG) acquisitions to assess brain activity, connectivity and structural changes, and blood sample.
PD-PIGD patients will be randomly allocated in two training groups: the REHAB+SHAM group and the REHAB + STIM group.
The REHAB+SHAM group will perform 2 cycles of dual-task gait/balance training consisting of action observation training (AOT) and motor imagery (MI) combined with practicing the observed-imagined exercises (an approach that has been demonstrated to be effective to improve gait and mobility in PD-PIGD), additionally they will undergo SHAM transcranial and trans-spinal stimulation. SHAM stimulation will be performed using the same montage used for transcranial and spinal stimulation (explained below), however an initial current is delivered and programmed to fade off in a brief period of time.
The REHAB + STIM group will perform the same exercises combined with non-invasive stimulation.
Non-invasive stimulation will be administered using tDCS with trans-spinal Direct Current Stimulation (tsDCS) or transcranial Direct Current Stimulation (tDCS) alone combined with SHAMtsDCS.
This design will aid in determining not only whether non-invasive stimulation can enhance rehabilitation outcomes but also whether the combination of tDCS and tsDCS could lead to improved results compared to tDCS alone.
The motor-cognitive training of the REHAB+SHAM group will consist of 2 cycles of SHAM stimulation and training lasting 6 weeks, 3 times per week, about 1 hour each session, separated by a 8-week washout period.
The REHAB + STIM group will undergo 2 cycles of the 6-week training, separated by a 8-week washout period with a cross-over design: half of subjects will first receive 6-week training with tDCS+SHAMtsDCS followed by 6-week tDCS+ tsDCS, while the other half will follow the reverse order, according to a randomization procedure.
After the training (i.e., 6-week visit [W6] and 20-week visit [W20]), PD-PIGD patients will be re-evaluated through neurological, cognitive/behavioural, gait/balance, neuroimaging/neurophysiology assessments and blood sample.
These measures (except for MRI at 14-week [W14] visit) will be also repeated at W14 and 28-week follow-up visits to assess maintenance of results.
20 healthy controls will also be recruited and evaluated at baseline. They will undergo the same assessments administered to PD-PIGD patients at T0 (neurological, cognitive/behavioural assessments, gait/balance evaluation using gait analysis systems, neuroimaging/neurophysiology, blood sample).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
The assessor blinded will be neurologists, neuropsychologists and physiotherapists who will perform the evaluations at each time point.
Patients will not know if they are receiving sham or real stimulation.
入排标准
- 年龄范围
- 45 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •45 years < age ≤ 85 years
- •Idiopathic PD according to the Movement Disorders Society (MDS) diagnostic criteria
- •Hoehn & Yahr (H&Y) score ≤ 4
- •PIGD phenotype
- •Stable dopaminergic medication for at least 4 weeks and without any changes during the observation period (28 weeks)
- •No dementia according to Litvan's criteria and Mini-Mental Status Examination score (MMSE) ≥ 24
- •No significant tremor/involuntary movements that could determine artifacts during the MRI acquisition
- •Oral and written informed consent to study participation
- •Healthy controls' inclusion criteria:
- •Sex-matched and age-matched (age range: mean age of PD years ± 15 years)
- •Oral and written informed consent to study participation
排除标准
- •Any major systemic, psychiatric, neurological, visual, and musculoskeletal disturbances or other causes of walking inability
- •Medical conditions or substance abuse that could interfere with cognition
- •Pacemaker or other implanted neurostimulation devices in the head/neck district
- •(Other) Contraindications to undergoing MRI examination
- •Brain damage at routine MRI, including extensive cerebrovascular disorders
- •Denied oral and written informed consent to study participation
- •Significant scalp traumatic or surgical wounds or scalp alterations that could determine a risk of infection in the site of non-invasive stimulation or the spread of excessive current from the device (only for patients receiving the neurostimulation).
结局指标
主要结局
Total execution time of Timed Up and Go test with cognitive dual-task (TUG-COG)
时间窗: Baseline, week 6, week 14, week 20 and week 28
Changes in time taken to complete the timed up and go test with cognitive dual-task: patients are asked to stand up from a chair, walk for three meters, turn and walk back to the chair while counting backwards by 3 starting from 100. Assessment during ON medication phase
次要结局
- Total execution time of Timed Up and Go test (TUG)(Baseline, week 6, week 14, week 20 and week 28)
- Total execution time of Timed Up and Go test with manual dual-task (TUG-MAN)(Baseline, week 6, week 14, week 20 and week 28)
- Movement Disorders Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) score(Baseline, week 6, week 14, week 20 and week 28)
- Brain functional changes during functional magnetic resonance imaging (MRI) tasks(Baseline, week 6, week 20 and week 28)
- Changes at resting-state functional Near-Infrared Spectroscopy (fNIRS)(Baseline, week 6, week 14, week 20 and week 28)
- Changes in Electroencephalography (EEG) signal(Baseline, week 6, week 14, week 20 and week 28)
- Serum concentration of Neurofilament light chain (NfL)(Baseline, week 6, week 14, week 20 and week 28)
- Activity Balance Confidence questionnaire (ABC) score(Baseline, week 6, week 14, week 20 and week 28)
- 10-meter walk test (10MWT) time(Baseline, week 6, week 14, week 20 and week 28)
- Mini Balance Evaluation System Test (MiniBESTest) score(Baseline, week 6, week 14, week 20 and week 28)
- Five-time sit-to-stand (5STS) time(Baseline, week 6, week 14, week 20 and week 28)
- Parkinson's Disease Questionnaire (PDQ-39) score(Baseline, week 6, week 14, week 20 and week 28)
- Kinesthetic and Visual Imagery Questionnaire (KVIQ)(Baseline, week 6, week 14, week 20 and week 28)
- Vividness of Movement imagery Questionnaire (VMIQ)(Baseline, week 6, week 14, week 20 and week 28)
- Parkinson Fatigue Scale (PFS)(Baseline, week 6, week 14, week 20 and week 28)
- Fatigue Severity Scale (FSS)(Baseline, week 6, week 14, week 20 and week 28)
- Modified Fatigue Impact Scale (M-FIS)(Baseline, week 6, week 14, week 20 and week 28)
- New Freezing of Gait Questionnaire (NFoG-Q)(Baseline, week 6, week 14, week 20 and week 28)
- Stride length(Baseline, week 6, week 14, week 20 and week 28)
- Gait velocity(Baseline, week 6, week 14, week 20 and week 28)
- Cambridge Neuropsychological Test Automated Battery (CANTAB)(Baseline, week 6, week 14, week 20 and week 28)
研究者
Prof. Massimo Filippi
Prof.
IRCCS San Raffaele