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Longitudinal Effects of Brain Stimulation on Decision-Making and Reward Learning

10 settembre 2026 aggiornato da: Dr. Nils B. Kroemer

Longitudinal Effects of Brain Stimulation Techniques (ECT, TMS, VNS, taVNS) on Decision-Making and Reward Learning

This study investigates the longitudinal effects of brain stimulation treatments on decision-making and reward learning. Here, we use daily assessments of reinforcement learning behavior in patients with depression who receive neuromodulation treatment to study potential associations between changes in decision-making and reward learning and changes in clinical symptoms.

Panoramica dello studio

Stato

Non ancora reclutamento

Descrizione dettagliata

Brain stimulation techniques are increasingly applied to treat mental disorders, especially when psychotherapy and psychopharmacotherapy fail (Conroy & Holtzheimer, 2021). The efficacy of treating treatment-resistant depression has been demonstrated using electroconvulsive therapy (ECT; Espinoza & Kellern, 2022; Subramanian et al., 2022), transcranial magnetic stimulation (TMS, Trapp et al., 2025), and vagus nerve stimulation (VNS, Kamel et al., 2022). With regard to transcutaneous auricular vagus nerve stimulation (taVNS), a motivation-enhancing effect has been demonstrated in individuals with depression (Ferstl et al., 2024).

It is unclear to what extent these stimulation techniques also affect cognitive processes, such as learning and decision-making behavior, and whether such changes can explain treatment success. Temporary cognitive side effects, such as memory impairments, are known to occur with ECT treatments (Landry et al., 2021). Initial evidence regarding learning and decision-making behavior is available for taVNS, in which the vagal auricular branch is noninvasively stimulated at the ear. Acute taVNS stimulation at the left ear showed a reduced learning rate particularly during punishment (Kühnel et al., 2020), as well as increased reward sensitivity (Weber et al., 2021). Additionally, TMS over the left dorsolateral prefrontal cortex was shown to alter the ratio of reward-to-punishment learning rates (Biernacki et al., 2023). However, these initial findings on learning and decision-making behavior and the underlying computational parameters relate to acute stimulation. Long-term effects of brain stimulation techniques on theses processes, as used in routine clinical practice (e.g., eight TMS sessions or daily stimulation of the vagus nerve) remain unclear to date. Likewise, the influence of fluctuations in mental state, such as mood, on learning and decision-making behavior over the course of a treatment, as well as potential changes in this influence after successful treatment, remain mostly unexplored. However, a recent study found, that fluctuations in metabolic state affected reward sensitivity and punishment learning rates in obesity (Kühnel et al., 2025). In the context of effort-based decision-making, it has been shown that fluctuations in motivation influence reward sensitivity (Hewitt et al., 2025).

It is also not yet possible to say to what extent stimulation-induced changes in clinical symptoms are reflected in possible changes in decision-making and reward learning. However, increasing evidence of altered computational mechanisms in patients points towards this potential connection. For example, higher punishment learning rates were observed in individuals with depression (Pike & Robinson, 2022) and anhedonia was linked to reduced reward sensitivity (Huys & Browning, 2025). Also, greater temporal discounting of future rewards was observed in individuals with depression compared to those without a diagnosis (Amlung et al., 2019). An open question remains, that is whether, as symptoms improve, changes in cognitive processes also diminish.

Based on the above, the following objectives have been established: First, the acute and mid-term effects of the mentioned neurostimulation therapies on computational processes of decision-making and reward learning will be investigated over the course of a clinical application. We expect, that brain stimulation lowers punishment learning rates (Hypothesis 1). Subsequently, the effects of the various stimulation methods on punishment learning rates will be compared (acutely after stimulation as well as over the course of the treatment). In addition, the influence of state fluctuations, such as mood, on computational parameters of decision-making and reward learning, such as learning rates, will be modeled. We expect, that fluctuations in mood, motivation, and metabolic state are associated with changes in punishment learning rates (Hypothesis 2). Next, we investigate the effect of brain stimulation on working memory. We expect, that ECT impairs working memory compared to the other treatments (Hypothesis 3). Finally, we expect that changes in punishment learning rates predict changes in symptoms of depression, general well-being, and somatic symptoms (Hypothesis 4), as well as cognitive side effects on working memory (Hypothesis 5).

Here, we use daily assessments of reinforcement learning with a gamified online task (Neuser et al., 2023) over the course of 8 weeks to track longitudinal effects of brain stimulation on decision-making and reward learning in patients with depression who receive neuromodulation treatment (N = 100). Daily assessments are accompanied by an ecological momentary assessment (EMA) of mood and metabolic states. At least five runs of the reinforcement learning task should be played before the first stimulation as a baseline. Additionally, working memory (backward digit span task), depressive symptoms (BDI-II), well-being (WHO-5), and somatic symptoms (PHQ-15) are measured online at the start of the study before the first treatment, after 4 weeks, and after 8 weeks at the end of the study. Patients will be recruited directly from the clinic after brain stimulation treatment is indicated for them..

Tipo di studio

Osservativo

Iscrizione (Stimato)

100

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Luoghi di studio

      • Bonn, Germania, 53127
        • Section of Medical Psychology, Department of Psychiatry & Psychotherapy, Faculty of Medicine, University of Bonn
        • Contatto:
          • Prof. Dr. rer. nat. Nils B Kroemer
          • Numero di telefono: +49 228 28719123
          • Email: nkroemer@uni-bonn.de

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Metodo di campionamento

Campione non probabilistico

Popolazione di studio

The study population consists of patients in the Department of Psychiatry and Psychotherapy at the University Hospital Bonn, who receive an indication for a brain stimulation treatment (ECT, TMS, VNS, taVNS).

Descrizione

Inclusion Criteria:

  • Indication for a brain stimulation treatment (ECT, TMS, VNS, taVNS) in the Department of Psychiatry and Psychotherapy at the University Hospital Bonn
  • Be able and willing to provide informed consent.

Exclusion Criteria:

  • Non-German speakers
  • Unclear ability to give consent to the study participation

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

Coorti e interventi

Gruppo / Coorte
Electroconvulsive therapy (ECT)
Participants receive ECT as a treatment within the clinic. ECT intentionally causes a generalized seizure by passing electrical currents through the brain under anesthesia. The treatment protocol (e.g., number of treatments) is independent of study participation and follows the doctor's orders. Participants are enrolled after the treatment indication is confirmed.
Transcranial magnetic stimulation (TMS)
Participants receive TMS as a treatment within the clinic. TMS is a non-invasive procedure in which a magnetic coil is used to induce electrical currents in the brain and thus influence cortex activity. The treatment protocol (e.g., number of treatments, type of TMS) is independent of study participation and follows the doctor's orders. Participants are enrolled after the treatment indication is confirmed.
invasive vagus nerve stimulation (VNS)
Participants receive VNS as a treatment within the clinic. VNS is a surgical treatment in which a stimulation device is implanted that sends electrical impulses to the vagus nerve. The treatment protocol (e.g., stimulation settings) is independent of study participation and follows the doctor's orders. Participants are enrolled after the treatment indication is confirmed.
transcutaneous vagus nerve stimulation (tVNS)
Participants receive tVNS as a treatment from the clinic for at home stimulation. To stimulate vagal afferents, the electrode will be placed at the cymba conchae of the right ear using a previously established conventional stimulation protocol (30s ON, 30s OFF; tVNS E device, tVNS Technologies GmbH, Erlangen, Germany). The stimulation can be applied for up to 4h per day and participants self-select stimulation time and duration based on the doctor's orders. Participants are enrolled after the treatment indication is confirmed.
Control
Participants receive an indication for a stimulation treatment within the clinic, but do not make use of it. Participants are included after treatment indication.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Punishment learning rates
Lasso di tempo: Assessed online up to 5 times before the first stimulation treatment and daily throughout the study (8 weeks).
The primary outcome are punishment learning rate estimates from a computational reinforcement learning model. Learning rates will be compared within and between stimulation conditions. Reinforcement learning is repeatedly measured with a bandit task with fluctuating reward probabilities (reward learning task). Reward learning behavior will be collected online over up to 60 runs, each including 150 trials.
Assessed online up to 5 times before the first stimulation treatment and daily throughout the study (8 weeks).

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Stimulation-induced mid-term changes in the backward digit span
Lasso di tempo: Assessed before the first stimulation treatment and after 4 and 8 weeks (10 minutes).
The primary outcome is the change in the backward digit span. Changes over time will be compared within conditions and between ECT and the other conditions. The backward digit span is the maximum sequence length that could be repeated correctly backwards in the digit span task (at least one out of two correct). The task runs two sequences per sequence length, starting at two digits and increasing by one digit up to eight digits. The task is terminated if both sequences of a sequence length could not be repeated correctly backwards. Scores range from 0 to 16 and are the number of correctly repeated sequences.
Assessed before the first stimulation treatment and after 4 and 8 weeks (10 minutes).
Correct choices in the reward learning task
Lasso di tempo: Assessed online at least 5 times before the first stimulation treatment and daily throughout the study (8 weeks).
The outcome describes the percentage of correct choices (wins) collected during the reward learning task. Choices are collected in each of the 150 trials per run.
Assessed online at least 5 times before the first stimulation treatment and daily throughout the study (8 weeks).
Reward sensitivity
Lasso di tempo: Assessed online at least 5 times before the first stimulation treatment and daily throughout the study (8 weeks).
The primary outcome is reward sensitivity estimates from a computational reinforcement learning model reflected by the inverse temperature parameters. Changes over time will be compared within and between stimulation conditions. Reinforcement learning is repeatedly measured with an bandit task with fluctuating reward probabilities (reward learning task). Reward learning behavior will be collected online over up to 60 runs, each including 150 trials.
Assessed online at least 5 times before the first stimulation treatment and daily throughout the study (8 weeks).
Weighting of learned values and rewards at stake (lambda)
Lasso di tempo: Assessed online at least 5 times before the first stimulation treatment and daily throughout the study (8 weeks).
The primary outcome is the weighting of win probability to reward magnitude weighting (lambda) from a computational reinforcement learning model. Changes over time will be compared within and between stimulation conditions. Reinforcement learning is repeatedly measured with an bandit task with fluctuating reward probabilities (reward learning task). Reward learning behavior will be collected online over up to 60 runs, each including 150 trials.
Assessed online at least 5 times before the first stimulation treatment and daily throughout the study (8 weeks).
Stimulation-induced mid-term changes in reward learning rates
Lasso di tempo: Assessed online at least 5 times before the first stimulation treatment and daily throughout the study (8 weeks).
The primary outcome is the change over time in reward learning rate estimates from a computational reinforcement learning model. Changes over time will be compared within and between stimulation conditions. Reinforcement learning is repeatedly measured with an bandit task with fluctuating reward probabilities (reward learning task). Reward learning behavior will be collected online over up to 60 runs, each including 150 trials.
Assessed online at least 5 times before the first stimulation treatment and daily throughout the study (8 weeks).
Association between mood state and punishment learning rates
Lasso di tempo: Assessed online at least 5 times before the first stimulation treatment and daily throughout the study (8 weeks).
The primary outcome is the association (regression coefficient) quantifying the relationship between mood state and punishment learning rates. Punishment learning rates are measured in the reward learning task. Mood state is calculated from two 0-100 visual analog scales (state happiness minus state sadness), which are asked before every run of the reward learning task.
Assessed online at least 5 times before the first stimulation treatment and daily throughout the study (8 weeks).
Association between metabolic state and punishment learning rates
Lasso di tempo: Assessed online at least 5 times before the first stimulation treatment and daily throughout the study (8 weeks).
The primary outcome is the association (regression coefficient) quantifying the relationship between metabolic state and punishment learning rates. Punishment learning rates are measured in the reward learning task and metabolic state is asked before every run of the reward learning task on a 0-100 visual analog scale (sated - hungry).
Assessed online at least 5 times before the first stimulation treatment and daily throughout the study (8 weeks).
Association between changes in punishment learning rates and changes in depressive symptoms
Lasso di tempo: Depressive symptoms are assessed before the first stimulation treatment and after 4 and 8 weeks. Reward learning is assessed online at least 5 times before the first stimulation treatment and daily throughout the study (8 weeks).
The primary outcome is the association (regression coefficient) quantifying the relationship between changes in punishment learning rates and changes in depressive symptoms. The regression model predicts changes in depressive symptoms from changes in punishment learning rates. Depressive symptoms are measured with the BDI-II (total scores, ranging from 0 to 63). Punishment learning rates are measured in the reward learning task.
Depressive symptoms are assessed before the first stimulation treatment and after 4 and 8 weeks. Reward learning is assessed online at least 5 times before the first stimulation treatment and daily throughout the study (8 weeks).
Association between motivational state and punishment learning rates
Lasso di tempo: Assessed online at least 5 times before the first stimulation treatment and daily throughout the study (8 weeks).
The primary outcome is the association (regression coefficient) quantifying the relationship between motivational state and punishment learning rates. Punishment learning rates are measured in the reward learning task and motivational state is asked before every run of the reward learning task on a 0-100 visual analog scale (not motivated - motivated).
Assessed online at least 5 times before the first stimulation treatment and daily throughout the study (8 weeks).
Association between changes in punishment learning rates and changes in mental well-being
Lasso di tempo: Mental well being is assessed before the first stimulation treatment and after 4 and 8 weeks. Reward learning is assessed online at least 5 times before the first stimulation treatment and daily throughout the study (8 weeks).
The primary outcome is the association (regression coefficient) quantifying the relationship between changes in punishment learning rates and changes in mental well-being. The regression model predicts changes in mental well-being from changes in punishment learning rates. Mental well being is measured with the WHO-5 (total scores, range from 0 to 30). Punishment learning rates are measured in the reward learning task.
Mental well being is assessed before the first stimulation treatment and after 4 and 8 weeks. Reward learning is assessed online at least 5 times before the first stimulation treatment and daily throughout the study (8 weeks).
Association between changes in punishment learning rates and changes in somatic symptoms
Lasso di tempo: Somatic symptoms are assessed before the first stimulation treatment and after 4 and 8 weeks. Reward learning is assessed online at least 5 times before the first stimulation treatment and daily throughout the study (8 weeks).
The primary outcome is the association (regression coefficient) quantifying the relationship between changes in punishment learning rates and changes in somatic symptoms. The regression model predicts changes in somatic symptoms from changes in punishment learning rates. Somatic symptoms are measured with the PHQ-15 (total scores, range from 0 to 30). Punishment learning rates are measured in the reward learning task.
Somatic symptoms are assessed before the first stimulation treatment and after 4 and 8 weeks. Reward learning is assessed online at least 5 times before the first stimulation treatment and daily throughout the study (8 weeks).
Association between changes in the backward digit span and changes in punishment learning rates
Lasso di tempo: Assessed online at least 5 times before the first stimulation treatment and daily throughout the study (8 weeks).
The primary outcome is the association (regression coefficient) quantifying the relationship between changes in the backward digit span and changes in punishment learning rates. The backward digit span is measured in the backward digit span task. Punishment learning rates are measured in the reward learning task.
Assessed online at least 5 times before the first stimulation treatment and daily throughout the study (8 weeks).
Response times in the reward learning task
Lasso di tempo: Assessed online at least 5 times before the first stimulation treatment and daily throughout the study (8 weeks).
The outcome describes response times collected during the reward learning task. Response times (milliseconds) are collected in each of the 150 trials per run.
Assessed online at least 5 times before the first stimulation treatment and daily throughout the study (8 weeks).
Backward digit span
Lasso di tempo: Assessed before the first stimulation treatment and after 4 and 8 weeks (10 minutes).
The primary outcome is the maximum sequence length that could be repeated correctly backwards (at least one out of two correct). The task runs two sequences per sequence length, starting at two digits and increasing by one digit up to eight digits. The task is terminated if both sequences of a sequence length could not be repeated correctly backwards. Scores range from 2 to 8.
Assessed before the first stimulation treatment and after 4 and 8 weeks (10 minutes).
BDI-II (Beck Depression Inventory-II)
Lasso di tempo: Assessed before the first stimulation treatment and after 4 and 8 weeks (10 minutes).
Questionnaire assessing depressive symptoms. Will be associated with behavioral outcomes. Total scores range from 0 to 63, with higher scores indicating greater depressive symptom severity.
Assessed before the first stimulation treatment and after 4 and 8 weeks (10 minutes).
WHO-5 (World Health Organization-Five Well-Being Index)
Lasso di tempo: Assessed before the first stimulation treatment and after 4 and 8 weeks (3 minutes).
Questionnaire assessing mental well being. Will be associated with behavioral outcomes. Total scores range from 0 to 30, with higher scores indicating better mental well being.
Assessed before the first stimulation treatment and after 4 and 8 weeks (3 minutes).
PHQ-15 (Patient Health Questionnaire-15)
Lasso di tempo: Assessed before the first stimulation treatment and after 4 and 8 weeks (5 minutes).
Questionnaire assessing the severity of somatic symptoms. Will be associated with behavioral outcomes. Total scores range from 0 to 30, with higher scores indicating higher severity of somatic symptoms.
Assessed before the first stimulation treatment and after 4 and 8 weeks (5 minutes).

Altre misure di risultato

Misura del risultato
Misura Descrizione
Lasso di tempo
Mood state
Lasso di tempo: Assessed online at least 5 times before the first stimulation treatment and daily throughout the study (8 weeks).
Ecological Momentary Assessment (EMA) using two 0-100 visual analog scales (mood state is calculated as state happiness minus state sadness), administered repeatedly across the reward learning task and lab sessions to capture mood state. We will assess changes in mood and associations with learning.
Assessed online at least 5 times before the first stimulation treatment and daily throughout the study (8 weeks).
Metabolic state
Lasso di tempo: Assessed online at least 5 times before the first stimulation treatment and daily throughout the study (8 weeks).
Ecological Momentary Assessment (EMA) using a 0-100 visual analog scale (sated - hungry), administered repeatedly across the reward learning task and lab sessions to capture metabolic state. We will assess changes in metabolic state and associations with learning.
Assessed online at least 5 times before the first stimulation treatment and daily throughout the study (8 weeks).
Motivational state
Lasso di tempo: Assessed online at least 5 times before the first stimulation treatment and daily throughout the study (8 weeks).
Ecological Momentary Assessment (EMA) using a 0-100 visual analog scale (unmotivated - motivated), administered repeatedly across the reward learning task and lab sessions to capture motivation. We will assess changes in motivation and associations with learning.
Assessed online at least 5 times before the first stimulation treatment and daily throughout the study (8 weeks).

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Investigatori

  • Investigatore principale: Nils B Kroemer, Prof. Dr., Section of Medical Psychology, Department of Psychiatry & Psychotherapy, Faculty of Medicine, University of Bonn

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

1 settembre 2026

Completamento primario (Stimato)

1 agosto 2028

Completamento dello studio (Stimato)

1 agosto 2028

Date di iscrizione allo studio

Primo inviato

10 settembre 2026

Primo inviato che soddisfa i criteri di controllo qualità

10 settembre 2026

Primo Inserito (Effettivo)

16 settembre 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

16 settembre 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

10 settembre 2026

Ultimo verificato

1 settembre 2026

Maggiori informazioni

Termini relativi a questo studio

Piano per i dati dei singoli partecipanti (IPD)

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Descrizione del piano IPD

After the publication of the key results of the study, anonymized data will be made publicly available (e.g., at osf.org).

Periodo di condivisione IPD

Anonymized data will be shared upon publication of the results

Criteri di accesso alla condivisione IPD

Until the data is publicly available, researchers may contact the lead PI to gain access.

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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