Standard Operating Procedure (SOP) for the Registration and Computer-supported Evaluation of Pharmaco-EEG Data

M, Versavel; Jp, Leonard; Wm, Herrmann

doi:10.1055/s-2007-979610

Cited by 8 publications

(7 citation statements)

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“…Spontaneous EEG power spectra variations with time must be considered for drug evaluation. Absolute power variations were shown to be more reliable than changes of relative power [2,35] . Absolute power density was therefore chosen as a target variable in the present study.…”

Section: Resultsmentioning

confidence: 99%

The Effects of Venlafaxine on Cognitive Functions and Quantitative EEG in Healthy Volunteers

Siepmann

Müeck-Weymann²,

Oertel³

et al. 2008

Pharmacopsychiatry

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Antidepressants that selectively block serotonin uptake may cause unwanted effects on cognitive functions such as impairment of vigilance and memory. A double-blind, randomized, placebo-controlled cross-over trial was performed to examine the effects of venlafaxine, a selective serotonin and noradrenaline reuptake inhibitor (SSNRI), on cognitive functions and quantitative EEG (qEEG) in humans. 12 healthy male subjects aged 23-32 years (26+/-3 years mean+/-sd) orally received 37.5 mg venlafaxine b.i.d. for 7 days and subsequently 75 mg b.i.d. for another 7 days. After a 14-day wash-out phase, placebo was administered to the subjects for 14 days under randomized double-blind cross-over conditions. Venlafaxine did not influence cognitive functions such as choice reaction, memory, psychomotor performance and subjective mood. Placebo resulted in an increase in slow alpha power (p<0.05) whereas venlafaxine had no effect on qEEG. In conclusion, multiple dosing with venlafaxine did not influence cognitive functions in healthy humans.

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Section: Resultsmentioning

confidence: 99%

The Effects of Venlafaxine on Cognitive Functions and Quantitative EEG in Healthy Volunteers

Siepmann

Müeck-Weymann²,

Oertel³

et al. 2008

Pharmacopsychiatry

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“…In the 80s and early 90s, several guidelines were published with the goal to standardise the acquisition and processing of data collected in pharmaco-EEG studies [2,3,4] or to provide procedural recommendations for the recording and quantitative analysis of EEG activity in research contexts [5]. The initial pharmaco-EEG guidelines were complemented in 1995 by another guidelines paper providing the framework identifying the key components and minimum requirements for data acquisition, amplification and filtering, the validation of hardware and software, artefact treatment and fast Fourier analysis [6]. …”

Section: Introductionmentioning

confidence: 99%

Advanced Analysis of Pharmaco-EEG Data in Humans

Jobert¹,

Wilson²

2015

Neuropsychobiology

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Pharmaco-electroencephalography (EEG) is a non-invasive method used to assess the effects of pharmacological compounds on the central nervous system by processing the EEG signals which directly reveal the spontaneous synchronised postsynaptic neuronal activity of the cortex with high temporal resolution. The International Pharmaco-Encephalography Society (IPEG) has recently published guidelines, which were produced by a global panel of EEG experts, with the goal to increase the standardisation of pharmaco-EEG studies in human subjects and facilitate the comparability of data across laboratories, thus enabling data-pooling and meta-analyses. The recommended standard experimental procedure is to measure EEG activity under vigilance-controlled and resting conditions. The IPEG guidelines thoroughly present the technical details and therefore constitute a robust reference. The complementary aim of the present paper is to focus on practical aspects, pitfalls and precautions to be considered when processing pharmaco-EEG data by covering the following topics: (1) investigate the stability and reliability of 5-min EEG recordings under both vigilance-controlled and resting conditions; (2) assess the spontaneous time-dependent changes in spectral activity over time, and (3) apply the data-processing strategies suggested in the pharmaco-EEG guidelines and designed to optimally capture drug effects. For this purpose, the EEG data from a randomised, double-blind, crossover trial aimed at comparing the effect of diazepam (10 mg) and placebo in 16 healthy male volunteers is used to illustrate the discussion of the processing techniques and difficulties commonly faced when analysing pharmaco-EEG data.

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“…The initial pharmaco-EEG guidelines were complemented in 1995 by another guideline paper providing the framework to build standard operating procedures (SOPs), identifying the key components and minimum requirements for data acquisition, amplification and filtering, the validation of hardware and software, artefact treatment and fast Fourier analysis [5]. This framework constituted the basis for setting up laboratory-specific SOPs.…”

Section: Introductionmentioning

confidence: 99%

Guidelines for the Recording and Evaluation of Pharmaco-EEG Data in Man: The International Pharmaco-EEG Society (IPEG)

Jobert¹,

Wilson

Ruigt³

et al. 2012

Neuropsychobiology

145

132

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The International Pharmaco-EEG Society (IPEG) presents updated guidelines summarising the requirements for the recording and computerised evaluation of pharmaco-EEG data in man. Since the publication of the first pharmaco-EEG guidelines in 1982, technical and data processing methods have advanced steadily, thus enhancing data quality and expanding the palette of tools available to investigate the action of drugs on the central nervous system (CNS), determine the pharmacokinetic and pharmacodynamic properties of novel therapeutics and evaluate the CNS penetration or toxicity of compounds. However, a review of the literature reveals inconsistent operating procedures from one study to another. While this fact does not invalidate results per se, the lack of standardisation constitutes a regrettable shortcoming, especially in the context of drug development programmes. Moreover, this shortcoming hampers reliable comparisons between outcomes of studies from different laboratories and hence also prevents pooling of data which is a requirement for sufficiently powering the validation of novel analytical algorithms and EEG-based biomarkers. The present updated guidelines reflect the consensus of a global panel of EEG experts and are intended to assist investigators using pharmaco-EEG in clinical research, by providing clear and concise recommendations and thereby enabling standardisation of methodology and facilitating comparability of data across laboratories.

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Standard Operating Procedure (SOP) for the Registration and Computer-supported Evaluation of Pharmaco-EEG Data

Cited by 8 publications

References 0 publications

The Effects of Venlafaxine on Cognitive Functions and Quantitative EEG in Healthy Volunteers

The Effects of Venlafaxine on Cognitive Functions and Quantitative EEG in Healthy Volunteers

Advanced Analysis of Pharmaco-EEG Data in Humans

Guidelines for the Recording and Evaluation of Pharmaco-EEG Data in Man: The International Pharmaco-EEG Society (IPEG)

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