Effects of Immersive Multisensory Stimulation in Disorders of Consciousness
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Coma Recovery Scale-r (CRS-r)
研究概览
简要总结
Disorder of consciousness (DoC) is a state in which consciousness is altered because of brain damage and can occur under a variety of conditions: in fact, the most frequent causes of DoC are vascular disease, head trauma, and cerebral hypoxia. DoCs result from the loss of regulation of neural function of the two components of consciousness, alertness and awareness. Depending on the patient's behavior and responsiveness, DoCs can be identified in different states, from coma to persistent vegetative state (VS) to intermittent minimally conscious state (MCS). Regarding the prognosis of recovery, in patients with DoC the chance of having functional improvement decreases with time, although some positive functional changes have been observed in chronic patients. Therapies for DoC include some drugs, such as dopaminergic, GABAergic and amantadine drugs, which work to facilitate the recovery of consciousness. Neurorehabilitation, however, seems to be the most recognized intervention that aims to strengthen, in uninjured brain regions, the spontaneous neuroplasticity that occurs to compensate for lost function.
Simultaneous stimulation of multiple senses, such as hearing, sight and smell, provides the neural network with more stimuli that are more effective than a single stimulus. In fact, multisensory stimuli can more easily activate attention because cortical processing is predominantly multimodal. As for content, it would seem that those with autobiographical and emotionally salient character could engage multiple brain networks and have priority access to attention. Numerous trials show that stimulus-containing content led to increased behavioural activity, improving self-awareness in patients with DoC.
Considering that a communication system that can combine both visual and auditory channels proves to be more effective than a "single-sense" channel, multisensory stimulation is likely to provide simultaneous activation of different brain areas by enhancing plasticity processes. Furthermore, the intensity of stimulation could be one of the main variables with greater impact on the patient: in fact, higher intensity would correspond to a greater effect on the brain.
详细描述
It can be hypothesized that sensory stimulation, or "Multisensorial IMmersive Experiences" (MIME), enhanced by high-quality video images, a larger screen size, and qualitatively better sound, may have a greater impact on the patient than the same image or video played on a small screen.
The purpose of the study is to evaluate (i) whether MIMEs can clinically modify the vigilance of DoC patients during administration; (ii) whether there is SNA activation during the administration of MIMEs; and (iii) whether patients treated daily with MIMEs have any benefits in terms of vigilance modification.
Twenty patients of both sexes with DoC will be recruited, evaluated and treated at the UOC of High Intensity Neurorehabilitation at the Fondazione Policlinico Universitario Gemelli IRCCS in Rome.
All study participants will undergo MIME treatment once a day for 5 days a week, for a total of 10 sessions. Patients will perform, in addition to MIME therapy, conventional rehabilitation as a daily routine. Patients will be divided into two groups: one part will perform MIME treatment concurrently with transcranial direct current stimulation (tDCS, G-Mt) and as many will undergo MIME treatment alone (G-M), as described below. In the case of epileptic subjects, these due to contraindications to tDCS may be subjected to MIME therapy only.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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
- •Age between 18 and 90 years Patients who have been in a coma state and have alterations in consciousness Patients who are not responsive to rehabilitative treatment of disorders of consciousness, such as environmental stimulation, non-invasive brain stimulation, or drug treatment.
- •Clinical stability Ability of caregiver/legal guardian to understand and sign informed consent
排除标准
- •Taking medications that interfere with membrane conductivity (e.g., calcium channel blockers, antiepileptic drugs).
- •Psychiatric or other medical conditions Failure to sign informed consent The presence of a history of epilepsy and/or taking antiepileptic therapy is an exclusion criterion for assignment to the MIME+tDCS group.
研究组 & 干预措施
MIME Group
Stimulation with MIME will be performed in a large ad hoc room in which video images will be projected on three walls. The patient will be positioned in the center of the room, 3 meters from the front wall, with the back of the bed tilted at a 45-degree angle, so as to obtain a truly immersive view covering the entire 220-degree field of view. Audio stimulation will be achieved through two speakers located at the sides of the room, with the low frequencies reinforced by a subwoofer. The average sound intensity recorded from the patient's position will be 81 db average (maximum 87, minimum 69).
Patients will undergo treatment with MIME once a day for five consecutive days, for a total of two weeks (10 sessions), in addition to conventional treatment.
干预措施: MIME (Other)
MIME + tDCS Group
Simultaneously with MIME treatment, patients will undergo transcranial direct current stimulation (tDCS). Stimulation with tDCS will begin 5 minutes after the start of resting phase 1, and the electrodes will be placed as follows: the 5×4 anode (about 20 cm2) will be placed on the left dorsolateral prefrontal area; the reference electrode, 6x5 (about 30 cm2), will instead be placed on the upper arm, specifically at the level of the right deltoid muscle, contralateral to the active electrode. Current will be applied at an intensity of 2 mA, for 20 minutes a day for 2 weeks, five days a week, for a total of 10 sessions. The current density will be kept below the safe limits reported in the literature.
干预措施: MIME + tDCS (Other)
结局指标
主要结局
Coma Recovery Scale-r (CRS-r)
时间窗: Change from baseline CRS-r at 2 weeks
CRS-r is an assessment tool that examines 6 functions: auditory, visual, oral-verbal motor, communicative, and vigilance. Its different items are organized hierarchically (low scores represent reflex activities, high scores describe cognitively mediated behaviors). For each function examined, the diagnosis of Vegetative State, Minimal Consciousness State, Emergence from Minimal Consciousness State can be made.
次要结局
- Electrodermal Activity (EDA)(Change from baseline EDA at 2 weeks)
- Level of Cognitive Functioning (LCF)(Change from baseline LCF at 2 weeks)
- Disability Rating Scale (DRS)(Change from baseline DRS at 2 weeks)
- Heart Rate Variability (HRV)(Change from baseline HRV at 2 weeks)
- Cognitive Reserve Index questionnaire (CRIq)(Assess CRIq at baseline)
- Lifetime Physical Activity Questionnaire (LTPAQ)(Assess LTAQ at baseline)
研究者
PADUA LUCA
Principal Investigator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS