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rTMS effects and the efficacy on behavioural addiction and depression

rTMS effects and the efficacy on behavioural addiction and depression - REWARD

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
DRKS
Registry ID
DRKS00036804
Enrollment
64
Registered
2025-05-02
Start date
2025-12-09
Completion date
Unknown
Last updated
2026-01-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

depression behavioural addiction F32 F33

Interventions

Group 1: The study differentiates between two groups. The first group (depression) has the following design: rTMS will be conducted on the first day (t1) as well as on twelve further stimulation sessi

Sponsors

Uniklinik Köln Klinik und Poliklinik für Psychiatrie, Psychosomatik und Psychotherapie des Kindes- und Jugendalters
Lead Sponsor

Eligibility

Sex/Gender
All
Age
12 Years to 17 Years

Inclusion criteria

Inclusion criteria: -Anamnestic sufficient knowledge of German -Ability to consent and agreement of parents and test persons -Depressive episode according to ICD-10 criteria (ICD-10 code: F32.1; F32.2; F32.8; F32.9; F33), whereby other established therapy methods must have already been carried out without sufficient success or expressly offered in accordance with the guidelines, but despite appropriate documented counseling and information OR behavioral addiction according to ICD 11 (computer game disorder (ICD-11 code: 6C51, “gaming disorder” or other specified disorders caused by behavioral addictions (ICD-11 code: 6C5Y), including social network use disorder). The diagnosis must have been made by a medical specialist or licensed child and adolescent psychotherapist. In addition, a semi-structured interview (children's DIPS) is conducted. - Sufficient compliance for participation in the study. In addition to the consent of the subjects, a medical history will be taken with the subject before the start of the study to check whether he/she can participate for the period planned in the study. - Right-handers assessed via the Edinburgh Handedness Inventory - No antidepressant medication or stable antidepressant medication in the last 6 weeks - Sexually active participants must be using effective contraception. This includes the use of hormonal or barrier contraception

Exclusion criteria

Exclusion criteria: -IQ = 70 - Contraindications for transcranial magnetic stimulation or MRI (e.g. implanted ferromagnetic material in the head area, epilepsy, focal brain injuries, pacemaker, cochlear implant, medication pump, tattoos containing metal, claustrophobia, increased intracranial pressure (e.g. after trauma or infection), increased susceptibility to cerebral seizures due to medication (e.g. according to the instructions for use of the TMS stimulator used; Wellbutrin, Zoloft, Adderall, fluoxetine, aripiprazole, lithium carbonate, clonazepam, lithium carbonate). systematic review by the study physician) - Prematurity before 32 weeks' gestation - Psychotropic medication, except as specified above - Hearing impairment - Pregnancy and breastfeeding - epilepsy and epilepsy in first-degree relatives as well as febrile convulsions in childhood - craniocerebral trauma - Requesting the right not to know for MRI as an exclusion criterion (i.e. persons who do not wish to be informed about potentially abnormal incidental findings) - Use or withdrawal from drugs (e.g. cannabis) or alcohol abuse. Testing is only carried out if there is clinical suspicion. - Exclusion criterion for each session: severe sleep deprivation

Design outcomes

Primary

MeasureTime frame
TMS-evoked potentials (TEPs) - N45 (The negative peak at 45 ms may serve as a potential biomarker for distinguishing between healthy and severely depressed brains.) - P60 (The positive peak occurring approximately 60 ms after TMS is thought to reflect glutamatergic activity within the brain, according to current evidence.) - N100 (The negative peak observed approximately 100 ms post-TMS is believed to reflect GABA-B mediated cortical inhibition.) Event-related potential (ERP) - Reward Positivity (Reward positivity is characterized by a positive-going ERP component in the EEG, typically observed between 200 and 400 ms following the presentation of a reward, and is thought to reflect reward-related neural processing.) Symptoms/ clinical effect on depressions - CDRS-R (Interview used to asses the diagnosis and severity of the depressive symptoms. The interview can be used for children and adolescents between 6 and 17 years.) - QSU-brief (adapted for behavioural addiction) (The QSU-Brief serves as a measure of current craving intensity and will be employed solely in participants assigned to the 'behavioral addiction' group.)

Countries

Germany

Contacts

Public ContactJohanna Loy

Uniklinik Köln Klinik und Poliklinik für Psychiatrie, Psychosomatik und Psychotherapie des Kindes- und Jugendalters

johanna.loy@uk-koeln.de+49 221 478 78941

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026