STIPED non invasive brain stimulation

Clinical trials

STIPED is an ambitious global partnership which will result in five randomized double-blind sham-controlled phase I and IIa proof-of-principle clinical trials establishing effect sizes and studying safety and tolerability of tDCS on cognitive and behavioural outcomes in children and adolescents with ADHD and ASD.

STIPED clinical trials
STIPED clinical trials

ADHD

Clinical study 1 (Leader: Dr. Vera Moliadze, CAU-IMPS; WP3): A randomized, double-blind, sham-controlled, crossover phase I study in healthy subjects will investigate 1) the interaction between structural and functional brain development and effects of tDCS, 2) the impact of concurrent tasks and 3) of individual modelling of electrical currents in the head/brain which may affect the tDCS outcome. This study will help to define optimal parameters of stimulation in order to reduce interindividual variability. The data management, monitoring and statistics will be provided by the WP9. Neurophysiological data (MRI, EEG, ERP) will be obtained and forwarded for analysis of biomarkers and mechanisms to WP6 & WP7.

Clinical studies 2 & 3 (Leaders: PD Dr. Alexander Prehn-Kristensen, ZIP for clinical stury 2 and PD Dr. Kerstin Krauel, OvGU for clinical study 3; WP4): Two randomized, double-blind, sham-controlled, parallel-group phase IIa studies will compare potential targets for tDCS in patients with ADHD. They will answer the question: which of two prefrontal cortical regions is the best candidate for normalizing neuropsychological dysfunctions in patients? These trials will apply previously established stimulation protocols which have been proven in our previous experimental research. The data management, monitoring and statistics will be provided by WP9. Neurophysiological data (MRI, EEG, ERP) will be obtained and forwarded for analysis of biomarkers and mechanisms to WP6 & WP7.

Clinical study 4 (Leader: Prof. Dr. Michael Siniatchkin, CAU-IMPS; WP4): Personalized home-based treatment using HOMEPTES (Home Pediatric Transcranial Electrical Stimulation) will be studied in a randomized, double-blind, sham-controlled, parallel-group phase IIa trial. This treatment will be associated with telemental health service for the improvement of tDCS applicability and supported by individual recommendation (WP2) addressing concerns and reservations. The data management, monitoring and statistics will be provided by WP9.

ASD

Clinical study 5 (Leader: Prof. Dr. med. Dipl. - Theol. Christine M. Freitag, GU; WP5): The efficacy and tolerability of tDCS will be proven in a randomised, double blind, sham-controlled, parallel group clinical phase-IIa study. The data management, monitoring and statistics will be provided by WP9. Neurophysiological data (MRI, EEG, ERP) will be obtained and forwarded for analysis of biomarkers and mechanisms to WP6 & WP7.

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Read the press release about the STIPED project launch. The press release is...

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