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

10 de setembro de 2026 atualizado por: 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.

Visão geral do estudo

Status

Ainda não está recrutando

Descrição detalhada

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 de estudo

Observacional

Inscrição (Estimado)

100

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Contato de estudo

  • Nome: Nils B Kroemer, Prof. Dr.
  • Número de telefone: +49 228 287 11151
  • E-mail: nkroemer@uni-bonn.de

Locais de estudo

      • Bonn, Alemanha, 53127
        • Section of Medical Psychology, Department of Psychiatry & Psychotherapy, Faculty of Medicine, University of Bonn
        • Contato:
          • Prof. Dr. rer. nat. Nils B Kroemer
          • Número de telefone: +49 228 28719123
          • E-mail: nkroemer@uni-bonn.de

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

  • Adulto
  • Adulto mais velho

Aceita Voluntários Saudáveis

Não

Método de amostragem

Amostra Não Probabilística

População do estudo

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).

Descrição

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

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

Coortes e Intervenções

Grupo / 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.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Punishment learning rates
Prazo: 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).

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Stimulation-induced mid-term changes in the backward digit span
Prazo: 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
Prazo: 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
Prazo: 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)
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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).

Outras medidas de resultado

Medida de resultado
Descrição da medida
Prazo
Mood state
Prazo: 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
Prazo: 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
Prazo: 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).

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Investigadores

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

Publicações e links úteis

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Publicações Gerais

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Estimado)

1 de setembro de 2026

Conclusão Primária (Estimado)

1 de agosto de 2028

Conclusão do estudo (Estimado)

1 de agosto de 2028

Datas de inscrição no estudo

Enviado pela primeira vez

10 de setembro de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

10 de setembro de 2026

Primeira postagem (Real)

16 de setembro de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

16 de setembro de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

10 de setembro de 2026

Última verificação

1 de setembro de 2026

Mais Informações

Termos relacionados a este estudo

Plano para dados de participantes individuais (IPD)

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SIM

Descrição do plano IPD

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

Prazo de Compartilhamento de IPD

Anonymized data will be shared upon publication of the results

Critérios de acesso de compartilhamento IPD

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

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

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