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临床试验/NCT01782391
NCT01782391撤回不适用

Impact of Transcranial Slow Oscillating Stimulation on Memory Consolidation During Nocturnal Slow Wave Sleep in Patients With Mild Cognitive Impairments(MCI)

Charite University, Berlin, Germany2 个研究点 分布在 1 个国家开始时间: 2013年4月最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
试验地点
2
主要终点
Retention of declarative memories after 0.75 Hz stimulation during SWS, vs after sham stimulation during SWS

研究概览

简要总结

The beneficial effect of nocturnal sleep on memory consolidation is well-documented in young, healthy subjects. Especially, periods rich in slow-wave sleep (SWS) have shown a memory enhancing effect on hippocampus-dependent declarative memory. Slow oscillatory activity typically occuring during SWS has been implicated in the consolidation effect. Recent evidence in young healthy subjects suggest that the sleep-associated consolidation effect can be amplified by the application of a weak transcranial oscillatory electric current within the frequency range of SWS in humans (0,7-0,8 Hz) during SWS. If patients with amnestic mild cognitive impairments (MCI)- usually characterized by initial difficulties in hippocampus dependent memory functions - benefit from transcranial slow oscillatory stimulation (tSOS) during nocturnal sleep as well has not been studied so far. The primary aim of the present study is to investigate the influence of a weak slow oscillating brain stimulation (tSOS) on declarative memory consolidation applied during periods of nocturnal SWS in MCI patients.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
Triple (Participant, Care Provider, Investigator)

入排标准

年龄范围
50 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • amnestic and amnestic plus MCI-patients:
  • Concern reflecting a change in cognition reported by patient or informant or clinician (i.e., historical or observed evidence of decline over time)
  • Objective evidence of memory impairment; additional cognitive domains may be affected as well;
  • Preservation of independence in functional abilities
  • no dementia
  • age: 50-90 years

排除标准

  • untreated severe internal or psychiatric diseases
  • other severe neurological diseases eg., previous major stroke, brain tumour
  • contraindications to MRI

结局指标

主要结局

Retention of declarative memories after 0.75 Hz stimulation during SWS, vs after sham stimulation during SWS

时间窗: 4 weeks

Retention between stimulation conditions (0.75 Hz during SWS, vs sham stimulation during SWS) in the declarative memory task.

次要结局

  • Amount of Slow wave Sleep, spindels, eeg-correlates, further memory systems(4 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Agnes Flöel

Prof. Agnes Flöel, MD

Charite University, Berlin, Germany

研究点 (2)

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