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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorDr. Nils B. Kroemer

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Non-German speakers

Unclear ability to give consent to the study participation

Trial population

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).

Trial design

Design model

Case-only

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

100 Participants
are grouped into 5 trial groups
Group A: Electroconvulsive therapy (ECT)
Group B: Transcranial magnetic stimulation (TMS)
Group C: invasive vagus nerve stimulation (VNS)
Group D: transcutaneous vagus nerve stimulation (tVNS)
Group E: Control

Trial outcomes

Primary outcomes

1

Punishment learning rates

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.

Time frame
Assessed online up to 5 times before the first stimulation treatment and daily throughout the study (8 weeks).

Secondary outcomes

1

Stimulation-induced mid-term changes in the backward digit span

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.

Time frame
Assessed before the first stimulation treatment and after 4 and 8 weeks (10 minutes).
2

Correct choices in the reward learning task

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.

Time frame
Assessed online at least 5 times before the first stimulation treatment and daily throughout the study (8 weeks).
3

Reward sensitivity

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.

Time frame
Assessed online at least 5 times before the first stimulation treatment and daily throughout the study (8 weeks).
4

Weighting of learned values and rewards at stake (lambda)

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.

Time frame
Assessed online at least 5 times before the first stimulation treatment and daily throughout the study (8 weeks).

Other outcomes

1

Mood state

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.

Time frame
Assessed online at least 5 times before the first stimulation treatment and daily throughout the study (8 weeks).
2

Metabolic state

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.

Time frame
Assessed online at least 5 times before the first stimulation treatment and daily throughout the study (8 weeks).
3

Motivational state

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.

Time frame
Assessed online at least 5 times before the first stimulation treatment and daily throughout the study (8 weeks).

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Dr. Nils B. Kroemer

Lead sponsor

University of Bonn

Sponsor institution

Department of Psychiatry University of Bonn

Collaborator

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