Leiden University Scholarly Publications

Mollan, S.P.; Fraser, C.L.; Digre, K.B.; Diener, H.C.; Lipton, R.B.; Juhler, M.; ... ; Jensen, R.H. 2023

Guidelines of the International Headache Society for controlled clinical trials in idiopathic intracranial hypertension

Article / Letter to editor

open access

The quality of clinical trials is essential to advance treatment, inform regulatory decisions and meta-analysis. With the increased incidence of idiopathic intracranial hypertension and the... Show moreThe quality of clinical trials is essential to advance treatment, inform regulatory decisions and meta-analysis. With the increased incidence of idiopathic intracranial hypertension and the emergence of clinical trials for novel therapies in this condition, the International Headache Society Guidelines for Controlled Clinical Trials in Idiopathic Intracranial Hypertension aims to establish guidelines for designing state-of-the-art controlled clinical trials for idiopathic intracranial hypertension. Show less

Khalili-Mahani, N.; Rombouts, S.A.R.B.; Osch, M.J.P. van; Duff, E.P.; Carbonell, F.; Nickerson, L.D.; ... ; Gerven, J.M. van 2017

Biomarkers, Designs, and Interpretations of Resting-State fMRI in Translational Pharmacological Research: A Review of State-of-the-Art, Challenges, and Opportunities for Studying Brain Chemistry

Article / Letter to editor

open access

A decade of research and development in resting‐state functional MRI (RSfMRI) has opened new translational and clinical research frontiers. This review aims to bridge between technical and clinical... Show moreA decade of research and development in resting‐state functional MRI (RSfMRI) has opened new translational and clinical research frontiers. This review aims to bridge between technical and clinical researchers who seek reliable neuroimaging biomarkers for studying drug interactions with the brain. About 85 pharma‐RSfMRI studies using BOLD signal (75% of all) or arterial spin labeling (ASL) were surveyed to investigate the acute effects of psychoactive drugs. Experimental designs and objectives include drug fingerprinting dose‐response evaluation, biomarker validation and calibration, and translational studies. Common biomarkers in these studies include functional connectivity, graph metrics, cerebral blood flow and the amplitude and spectrum of BOLD fluctuations. Overall, RSfMRI‐derived biomarkers seem to be sensitive to spatiotemporal dynamics of drug interactions with the brain. However, drugs cause both central and peripheral effects, thus exacerbate difficulties related to biological confounds, structured noise from motion and physiological confounds, as well as modeling and inference testing. Currently, these issues are not well explored, and heterogeneities in experimental design, data acquisition and preprocessing make comparative or meta‐analysis of existing reports impossible. A unifying collaborative framework for data‐sharing and data‐mining is thus necessary for investigating the commonalities and differences in biomarker sensitivity and specificity, and establishing guidelines. Multimodal datasets including sham‐placebo or active control sessions and repeated measurements of various psychometric, physiological, metabolic and neuroimaging phenotypes are essential for pharmacokinetic/pharmacodynamic modeling and interpretation of the findings. We provide a list of basic minimum and advanced options that can be considered in design and analyses of future pharma‐RSfMRI studies. Hum Brain Mapp 38:2276–2325, 2017. © 2017 Wiley Periodicals, Inc. Show less