Efficacy of Repetitive Transcranial Magnetic Stimulation (r-TMS) Combined With Visual Scanning Treatment on Cognitive-behavioral Symptoms of Unilateral Spatial Neglect in Patients With Traumatic Brain Injury: a Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- visual-Attention Bias Index (vABI)
研究概览
简要总结
Randomized Controlled Trial (RCT) aiming at assessing the efficacy of a novel rehabilitation protocol, based on repetitive transcranial magnetic stimulation (r- TMS) in combination with a conventional cognitive treatment (CCT). The protocol will be statistically compared to the same CTT administered without the r-TMS in a sample of traumatic brain injury patients (age between 18 and 80 years) with left hemispatial Neglect.
详细描述
BACKGROUND: A frequent and disabling impairment in persons who suffered traumatic brain injury (TBI) is left hemi-spatial neglect (LHSN). LHSN is a spatial attentive syndrome, characterized by a reduced ability to attend, perceive and consciously represent the left contra-lesional space, in the absence of a primary sensory deficit. Persons with LHSN fail to attend any stimulus coming from the left space and this can affect the ability to carry out many everyday tasks, such as walking, eating, reading and getting dressed. Those patients, as a direct consequence of the brain injury and LHSN, are also often affected by anosognosia for hemiplegia and for LHSN, which is the lack of awareness about motor and cognitive deficits. This condition hinders motor and cognitive recovery, predisposes to falls and reduces independence. Furthermore, in TBI LHSN is often associated with a mixture of attention, memory, executive function, and processing speed deficits leading to complex cognitive and behavioral pictures, which may even interfere with the administration of standard cognitive treatments for LHSN (i.e. visual scanning protocols or prism adaptation). It is also known that 1 Hz inhibitory repetitive Transcranial Magnetic Stimulation (rTMS), applied for two weeks to the posterior parietal cortex (PPC) of the unaffected hemisphere in patients with LHSN due to ischemic lesion of the right hemisphere, induces a significant improvement of visual-spatial symptoms that persists 15 days after rTMS treatment. These results can be explained considering that spatial attention deficit in LHSN due to a right middle cerebral artery territory stroke relates to abnormal activation of neural system that mediates spatial attentive operations in the healthy brain. In LHSN, a lesion of the right PPC and of the inter-hemispheric connectivity causes an imbalance in interhemispheric activity due to hyperactivity of the left hemisphere which, in turn, causes a biased attentive allocation towards ipsilesional space. As a consequence, an inhibition of this hyperactivity may have a rebalancing effect, reducing left spatial attention deficit in LHSN. Indeed, recent studies in stroke showed also the possibility of improving the efficacy of standard cognitive treatments (i.e. visual scanning) if the latter are preceded by inhibitory rTMS on the unaffected hemisphere. What is not known is whether also in LHSN due to TBI, inhibitory rTMS on the left PPC followed by a visual scanning protocol may be an effective treatment as in right hemisphere stroke, considering that in TBI the damage is often more widespread and multifocal than in the former condition.
AIMS:
- To compare the efficacy of a combined r-TMS and CCT intervention aiming at reducing cognitive symptoms of LHSN, in a sample of TBI patients with LHSN, within the context of an RCT.
- To evaluate the long- term impact of the intervention and evaluate the effect of the intervention on several clinical measures (activity of daily living, attentive and motor functions) and on psychophysiological indices
METHODS: Randomized controller trial, with blind assessments on pretest, postest and on 3 months follow-up.
POPULATION: TBI patients with clinical evidence of LHSN. INTERVENTION: Inhibitory low-frequency r-TMS on the left parietal cortex combined with a conventional cognitive treatment (visual scanning training) for 2 weeks.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of TBI;
- •Diagnosis of LHSN with specific assessment tests (line bisection test and / or star cancellation test);
- •Intra-hospital rehabilitation setting (ordinary hospitalization or DH);
- •Age between 18 and 80 years;
- •Time after injury between three weeks and 1 year;
- •Level of cognitive functioning (LCF ≥5 )
- •Adequate language comprehension
排除标准
- •Clinical instability at enrollment (for example, fever, acute internist conditions, etc.);
- •Presence of epileptogenic alterations to the EEG and / or previous epileptic seizures;
- •Presence of intracranial implants of metallic material;
- •Presence of devices that could be altered by rTMS, such as pacemakers, ventriculo-peritoneal derivations, Baclofen pump;
- •Acute neurosurgery, including decompressive craniotomy;
- •Drugs conditioning the state of consciousness-vigilance such as benzodiazepines;
- •Cortical blindness and / or visual agnosia;
- •Concomitant psychiatric disorders and / or history of substance abuse;
- •Post-traumatic agitation
- •Post-traumatic complications (i.e. hydrocephalus)
研究组 & 干预措施
r-TMS group
The interventions have a total administration time of 75 minutes per day. For rTMS stimulation, the coil will be positioned tangentially on the target area. Each rTMS session will last 15 minutes and will be administered every other day (e.g. Monday-Wednesday-Friday, Monday-Wednesday-Friday, Monday). The CCT (i.e. visual scanning treatment) involves the presence of a therapist, who administers various visual scanning tasks, used to increase patient's awareness and to teach strategies to improve spatial exploration abilities.Trainings include three increasing levels of difficulty (9 possible combinations). Each level of difficulty will be exercised until the patient reaches a level of accuracy of 75%. The CCT will be carried out in 50 minutes sessions for 5 days a week within 15 days (11 sessions in total). On the days when the rTMS is also administered, the administration of the CCT will immediately follow the brain stimulation.
干预措施: Inhibitory repetitive transcranial magnetic stimulation (Device)
SHAM group
SHAM Stimulation and Visual Scanning training. In the control group, the coil of the r-TMS will be positioned at 90° on the target area, thus no specific cortical modulation will be implemented (SHAM stimulation). For the SHAM group, the CCT protocol will be administered with the same modalities and time frame as detailed for the experimental group.
干预措施: Sham Group (Device)
结局指标
主要结局
visual-Attention Bias Index (vABI)
时间窗: up to 21 days post baseline and up to 90 days follow-up
Change from Baseline: visual-Attention Bias Index (vABI). Psychophysiological index of inter-hemispheric imbalance in a visual-spatial attention task
次要结局
- Motricity Index (MI)(up to 21 days post baseline and up to 90 days follow-up)
- test of Attention Performance (TAP/TEA)(up to 21 days post baseline and up to 90 days follow-up)
- behavioral Inattention Test (BIT)(up to 21 days post baseline and up to 90 days follow-up)
- functional independence measure (FIM)(up to 21 days post baseline and up to 90 days follow-up)
- Trunk Control Test (TCT)(up to 21 days post baseline and up to 90 days follow-up)
- Level of Cognitive Functioning (LCF)(up to 21 days post baseline and up to 90 days follow-up)
- catherine Bergegò Scale (CBS)(up to 21 days post baseline and up to 90 days follow-up)
- Inter Hemispheric transmission Time (IHTT)(up to 21 days post baseline and up to 90 days follow-up)