The Neuromodulatory Effect of Combined Transcranial Direct Current Stimulation (tDCS) With Aphasia Therapy in the Acute Phase After Ischemic Stroke
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 1
- 试验地点
- 2
- 主要终点
- Change in naming performance
研究概览
简要总结
This study evaluates the neuromodulatory effect of combined tDCS and aphasia therapy in patients in the acute stage after stroke. Half of the participants will receive aphasia therapy and tDCS, the other half will receive aphasia therapy and sham-tDCS.
详细描述
Aphasia is present in about one third of all stroke patients in the acute phase. The first few months after stroke, considerable spontaneous recovery is initiated, including neuronal plasticity and reorganization processes. Language recovery in aphasic stroke patients involves reorganization of brain functions. Longitudinal fMRI studies reveal that the right hemisphere shows increased activity at different times in the recovery process, but in the long-term is correlated with poorer performance. Left re-lateralization, if possible, seems to be the most effective in restoring language function. For a large subgroup of patients, aphasia therapy is not sufficient to resolve language deficits and not all patients are capable to endure intensive aphasia therapy. Therefore, non-invasive techniques (NIBS) such as transcranial direct current stimulation (tDCS) are currently explored as an add-on treatment to improve or accelerate therapy outcomes. tDCS is a painless and safe stimulation tool that modulates cortical excitability through weak polarizing currents (1 mA - 2 mA) between two electrodes. These weak currents are thought to induce a subthreshold shift of resting membrane potentials towards depolarization or hyperpolarization. The effects of stimulation depend on the polarity of the applied current relative to the axonal orientation. It has been found that tDCS not only triggers immediate aftereffects, but also long-lasting effects that persist beyond the stimulation time, even for up to 12 months. It was suggested that long-term potentiation (LTP) and long-term depression (LTD) might be responsible for these long-term effects, however the precise physiologic mechanisms of action are not yet fully understood.
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, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 85 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with mild-moderate aphasia (Token Test Score between 7 and 40)
- •Inclusion in the first few days after stroke (acute phase)
- •Age 18 - 85 years
- •Being right-handed
- •Mothertongue: Dutch
- •Able to undergo functional and specific linguistic testing and therapy in the acute phase following stroke
- •Imaging (CT or MRI) prior to inclusion (standard of care)
- •Signed Informed Consent
排除标准
- •History of other diseases of the central nervous system, psychological disorders and (developmental) speech and or language disorders
- •Serious non-linguistic, cognitive disorders (as documented in the patients' medical history and inquired in anamneses)
- •Prior brain surgery
- •Excessive use of alcohol or drugs
结局指标
主要结局
Change in naming performance
时间窗: baseline, 1 week, 3 months, 6 months
Naming performance will be assessed with the Boston Naming Test at baseline, immediately following therapy, and after 3 and 6 months
Change in Vital Parameters
时间窗: baseline, 1 hour (each session)
Blood pressure and heart rate will be measured before and after each session of treatment
次要结局
- Change in tolerability (Visual analogue scale)(baseline, 1 hour (each session))
- Change in Spontaneous Speech(baseline, 1 week, 3 months, 6 months)
- Change in ERPs(baseline, 1 week, 3 months, 6 months)
