跳至主要内容
临床试验/NCT01168466
NCT01168466已完成不适用

Pilot Study of EEG and Cerebral Blood Flow Biofeedback Training in Remediating Cognitive and Behavioral Deficits in Adults With a Dementing Illness.

Quietmind Foundation2 个研究点 分布在 1 个国家目标入组 37 人开始时间: 2007年6月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
37
试验地点
2
主要终点
Delis-Kaplan Executive Function System, Behavior Rating Inventory of Executive Function- Adult Version, Integrated Visual and Auditory Continuous Performance Test, Symptom Checklist 90R

研究概览

简要总结

This study measures whether the symptoms of frontotemporal dementia (FTD) can be successfully treated by (a) biofeedback training to increase brain blood flow, (b) biofeedback to increase the frequency of the brain's dominant brainwave rhythm, and (c) rhythmic stimulation to increase the brain's dominant brainwave frequency.

详细描述

Objectives and Significance

  1. What is (are) the primary goal(s) of the study The purpose of this study is to evaluate the efficacy of biofeedback training to increase regional cerebral blood flow (CBF) and peak alpha frequency (PAF) on the cognitive and behavioral symptoms of frontotemporal dementia (FTD). We will also measure the effects of EEG driven photostimulation during PAF neurofeedback on learning of higher PAF states and related clinical outcomes.
  2. What is (are) the secondary goal(s) of the study A diversity of clinical, neuropsychological, and physiological variables will be collected in this study. For instance, a full 19-channel quantitative EEG (QEEG) assessment will be performed at intake. The relationship between EEG power and coherence and the symptoms of this disorder could potentially provide an important contribution to the literature on the usefulness of QEEG for differential diagnosis.

An additional goal of the study is to contribute to the understanding of how neurofeedback works. For instance, we will take measurements to determine if learning to control the PAF involves awareness of some internal subjective state related to the PAF. Also, the effect of the reward signal on a brainwave called the P300 may show the importance of having the reward tone sounding the majority of the time during neurofeedback sessions. Finally, we will measure whether blood flow changes during EEG biofeedback and whether the EEG is affected by blood flow biofeedback.

We propose several measurements that will contribute to an understanding of the mechanism of action of neurofeedback.

Frontotemporal Dementia and Cerebral Hyperperfusion Single photon emission computed tomography (SPECT) studies have shown cerebral blood flow to be significantly reduced in the frontal and temporal regions in FTD patients (Miller et al., 1997; Read et al., 1995). The anatomical distribution of reduced CBF corresponds to the pattern of neuropsychological deficits (McMurtray et al., 2006).

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
45 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • FTD Symptoms reported by self or caregiver Significantly abnormal scores on Delis-Kaplan Executive Function System and Behavior Rating Inventory of Executive Function- Adult Version

排除标准

  • 45 years of age
  • no one with Axis I dx of Bipolar, Psychosis or active Substance Abuse
  • no severe Axis II disorders
  • symptoms manifesting within the last 5 years and person is still somewhat independent regarding their ADLs.

结局指标

主要结局

Delis-Kaplan Executive Function System, Behavior Rating Inventory of Executive Function- Adult Version, Integrated Visual and Auditory Continuous Performance Test, Symptom Checklist 90R

时间窗: Within two weeks of last session

EEG amplitude

时间窗: within two weeks of last session

decreased slow wave amplitudes from 1-4hz

次要结局

未报告次要终点

研究者

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

Marvin H. Berman, Ph.D.

President

Quietmind Foundation

研究点 (2)

Loading locations...

相似试验