跳至主要内容
临床试验/NCT03305614
NCT03305614终止2 期

The Neuromodulatory Effect of Combined Transcranial Direct Current Stimulation with Intensive Aphasia Therapy in the Chronic Phase After Stroke

University Hospital, Ghent1 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2017年11月24日最近更新:
适应症
干预措施

试验速览

阶段
2 期
状态
终止
入组人数
25
试验地点
1
主要终点
Change in naming performance assessed with the Boston Naming Test

研究概览

简要总结

This study evaluates the neuromodulatory effect of combined tDCS and aphasia therapy in patients in the chronic phase 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 chronic 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
Quadruple (Participant, Care Provider, 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 to moderate aphasia (Token Test Score between 7 and 40) after a first left hemispheric ischemic or hemorrhagic stroke
  • •Inclusion > 6 months post-stroke
  • •Age 18 - 85 years
  • •Being right-handed (> +8 on the questionnaire for handedness, Van Strien)
  • •Mothertongue: Dutch
  • •Imaging (CT or MRI) prior to inclusion (in patient file), standard of care in the acute phase
  • •Signed Informed Consent (attachment 1)

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 the anamneses)
  • •Prior brain surgery
  • •Excessive use of alcohol or drugs
  • •New neurological symptoms between the acute stage and inclusion

研究组 & 干预措施

Aphasia therapy and tDCS

Active Comparator

combined tDCS and aphasia therapy and the effect of conventional intensive aphasia

干预措施: tDCS (Procedure)

Aphasia therapy and tDCS

Active Comparator

combined tDCS and aphasia therapy and the effect of conventional intensive aphasia

干预措施: Aphasia therapy (Procedure)

Aphasia therapy and sham-tDCS

Sham Comparator

computer-based intensive aphasia therapy as measured by specific linguistic tests

干预措施: Aphasia therapy (Procedure)

结局指标

主要结局

Change in naming performance assessed with the Boston Naming Test

时间窗: baseline, 3 weeks, 3 +/-1 month

Naming performance will be assessed with the Boston Naming Test at baseline, immediately following therapy, and after 3 +/- 1 month following treatment

次要结局

  • Change in tolerability assessed with a Visual analogue scale(baseline, 2 hour (each session))
  • Change in spontaneous speech assessed with a Semi-standardized interview of the AAT(baseline, 3 weeks, 3 +/- 1 month)
  • Change in ERPs(baseline, 3 weeks, 3 +/- 1 month)
  • Change in quality of life assessed with the SAQOL-39-NL(baseline, 3 weeks, 3+/- 1 month)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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