NL-OMON56853招募中2 期
eurostimulation for the treatment of mild cognitive impairment in Parkinson*s disease: an acceptability cross-over study - NESCIO-PD
Amsterdam UMC0 个研究点目标入组 20 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 20
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 64（—）
入选标准
- •- Clinical diagnosis of Parkinson*s disease, diagnosed by a neurologist;
- •- Mild to moderate disease stage (Hoehn & Yahr disease stage < 4);
- •- Movement Disorders Society Level I criteria for PD-MCI;
- •- In case of (dopaminergic) medication use, participants are on stable
- •medication for at least one month before participation and expect to remain on
- •stable medication during the study.
排除标准
- •A potential subject who meets any of the following criteria will be excluded
- •from participation in this study:
- •- Indication for dementia based on the SAGE (cut-off < 14; Scharre et al.,
- •- Severe depressive disorder (Beck Depression Inventory - Ib score > 18);
- •- Psychotic disorder (except for benign hallucinations with insight), screened
- •with the Scale for Assessment of Positive Symptoms for Parkinson*s disease;
- •- Indication of alcohol or drug abuse;
- •- Contra-indication for NIBSrTMS according to Magstim Rapid2 Manual; rTMS
- •should not be::
- •used on or in the vicinity of patients or users with cardiac demand
- •pacemakers, implanted medication pumps, cochlear devices, implanted
- •defibrillators and/or implanted neurostimulators
- •used on or in the vicinity of patients with implanted metal objects• used on
- •patients where the skin in the area to be contacted is broken
- •used on patients who suffer from multiple sclerosis
- •used on those with large ischaemic scars
- •used on pregnant women
- •used on infants under the age of 2 years
- •used on epileptic individuals
- •used on those with a family history of convulsions
- •used on individuals with brain lesions that could affect seizure threshold
- •used on individuals suffering from multiple sclerosis
- •used on individuals taking tricyclic antidepressants, neuroleptic agents or
- •any other drug that could lower seizure threshold,
- •used on individuals suffering from sleep deprivation during rTMS procedures
- •used on individuals with a heavy consumption of alcohol or those using
- •epileptogenic drugs
- •used on individuals with severe heart disease or with increased intracranial
- •pressure be used on those who have uncontrolled migraines
- •- Contra-indication for tDCS according to Neuroelectrics Starstim Manual; tDCS
- •should not be used in case of:
- •Patients with a history of seizures;
- •Patients with unexplained episodes of loss of consciousness, since such
- •condition could be related with brain alterations or epilepsy;
- •Patients with unstable or non-controlled neuropsychiatric illness;
- •Patients having implanted brain medical devices;
- •Patients with implanted pacemakers;
- •Patients having any electrically, magnetically or mechanically activated
- •Patients having cardiac, neural or medication implants;
- •Patients having vascular clips or any other electrically sensitive support
- •system in the brain;
- •Patients with serious brain injury;
- •Patients showing damage of skin at sites of stimulation (the device can only
- •be used in healthy skin without wounds, otherwise the resistance to current can
- •be altered);
- •Patients suffering from skin problems, such as dermatitis, psoriasis or
- •Patients suffering from severe or frequent headaches;
- •Patients with any serious life-threatening disease such as congestive heart
- •failure, pulmonary obstructive chronic disease or active neoplasia;
- •Pregnant women (women of childbearing age should undertake a pregnancy test
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