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Neuromodulation of Motivation and Reward Oscillations (NEMO)

3. November 2026 aktualisiert von: Rick James Macatee, Florida State University

Delta and Theta-Frequency Transcranial Alternating Stimulation Neuromodulation of Motivation and Reward Oscillations in Disorder of Reward Dysfunction.

Cannabis use disorder (CUD) and major depressive disorder (MDD) are among the most prevalent psychiatric conditions in the United States, affecting an estimated 20.6 million and 21 million adults respectively. Both disorders are characterized by anhedonia, diminished motivation, and blunted neural reward sensitivity. This shared dysregulated reward-processing may reflect a common prefrontal oscillatory dysfunction, centralized in mesolimbic dopaminergic reward pathways. This proposed project aims to investigate if transcranial alternating current (tACS) can modulate motivational behaviours and neural reward responsivity in participants with MDD and/or CUD during an effortful reward task. The investigators hypothesize that delta transcranial alternating current stimulation will produce a greater neural reward responsivity (RewP), and motivational behaviour during an effortful reward task.

Studienübersicht

Status

Rekrutierung

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

Disrupted reward processing is a transdiagnostic feature that plays a central role in the development, and maintenance of anhedonia in Cannabis Use Disorder (CUD) and Major Depressive Disorder (MDD). Reward positivity (RewP) is an event-related potential (ERP) component derived from electroencephalogram (EEG) data, associated with motivation, reward responsivity and valuation. This neural signature originates in the medial and dorsolateral prefrontal cortexes. In MDD, reduced RewP has been associated with decreased willingness to expend effort for reward. Research of CUD and RewP is scarce, but dampened RewP has been demonstrated across different substances use disorders (SUDs) in response to monetary reward tasks. Taken together, these findings signal an emerging research frontier to establish RewP as a clinical biomarker and create a compelling mandate for causal investigation. Low-frequency neural oscillations are the key mechanisms facilitating long-distance prefrontal connectivity and interregional communication. Delta oscillations (2.5Hz) in medial and left lateral prefrontal cortexes are closely linked to RewP and reward prediction error signaling, while theta oscillations (6Hz) index cognitive control and prefrontal regulatory engagement during reward processing. Disruptions in both bands have been well documented in MDD, to a more limited extent, in cannabis-using populations. The proposed experiment will causally test whether sham, delta, and theta frequency tACS can alter motivation and reward responsivity (behaviourally [Effort behaviour] and neurally [RewP, delta power]), in participants with disorder of reward dysfunction, CUD, MDD, and healthy controls. Findings from the proposed study will aid in mechanistic understanding of prefrontal circuits underlying reward impairment in CUD and MDD, and ultimately enable for the development of novel brain stimulation techniques to target disorder-maintaining anhedonia. The investigators hypothesise that delta tACS will modulate reward responsivity in participants with disorders of reward. Such that, during the EEfRT Task delta stimulation will enhance reward responsive goal directed behaviour (Behavioral H1) and delta phase connectivity between left lateral and medial frontal electrodes (Neural H1) at effort decision period. As well as greater reward positivity (RewP; Neural 2), and win vs. loss delta power and phase coherence at feedback (Neural H3).

Studientyp

Interventionell

Einschreibung (Geschätzt)

54

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

  • Name: Zoe Howell Doctoral Student PI, M.Res.
  • Telefonnummer: 850-644-2445
  • E-Mail: brains@psy.fsu.edu

Studienorte

  • Vereinigte Staaten
    • Florida
      • Tallahassee, Florida, Vereinigte Staaten, 32306-4301
        • Noch keine Rekrutierung
        • The BRAINS Lab at Florida State University
        • Kontakt:
          • Zoe A Doctoral Student PI, M.Res.
          • Telefonnummer: 850-644-2445
          • E-Mail: brains@psy.fsu.edu
      • Tallahassee, Florida, Vereinigte Staaten, 32306-4301
        • Rekrutierung
        • The Riddle Lab at Florida State University
        • Kontakt:

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

18 Jahre bis 55 Jahre (Erwachsene)

Akzeptiert gesunde Freiwillige

Ja

Studienberechtigte Geschlechter

Alle

Beschreibung

Inclusion Criteria (General):

  • Aged between 18 - 55 years old.
  • Able to provide informed consent
  • Have normal to corrected vision
  • Willing to comply with all study procedures and be available for the duration of the study
  • Speak and understand English.
  • Negative THC saliva test and alcohol breathalyzer at all lab visits.
  • Negative UTOX for any substance other than THC.

Exclusion Criteria (General):

  • Mania history (Bipolar I, or current mania).
  • Psychosis history.
  • Current suicide intent (score >4 on C-SRSS, or intent >0 on SRA)
  • Current moderate-to-severe SUD or AUD (Except CUD and nicotine for NEMO-CUD).
  • Current pregnancy.
  • Seizure, neurological conditions, or brain surgery history.
  • Implanted medical devices (e.g., cochlear implants, cardiac pacemakers).
  • Change in psychotropic medication in the past 3 months (i.e., medication needs to be stable for 12 weeks).
  • Use of seizure threshold lowering medication (e.g., Stimulants, Benzos, SNRIs, Antipsychotics [Adderall, Vyvanse, Xanax, Wellbutrin, Cymbalta, Lithium] - SSRIs not exclusionary).

Specific CUD Inclusion:

  • Avg. 6+ cannabis use days per week over the past 3-months, and 24+ cannabis use days in the past 30 days.
  • Primary delta-9 or THC-A cannabis flower or vape concentrate user.
  • Current moderate-to-severe CUD (4+ criteria in the past year, at least one criterion other than craving must be met in the past three months).
  • Cannabis is the primary substance of use (Nicotine dependence is allowable)
  • Not currently receiving treatment for cannabis, planning to immediately quit or reduce use.
  • Lifetime history of MDE/PDD must have lifetime anhedonia symptom and/or heavy cannabis user (3+ sessions daily for at least past year including the past 3-months and past 30 days).

Specific MDD Inclusion:

  • Current MDE diagnosis.
  • No lifetime history of severe SUD.
  • No current moderate-to-severe SUD.
  • 100% of NEMO-MDD participants elevated anhedonia on TEPS-C (i.e., 32 or lower on TEPS-C subscale).

Specific Control Inclusion:

  • No current or historical psychiatric diagnosis.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Grundlegende Wissenschaft
  • Zuteilung: Zufällig
  • Interventionsmodell: Crossover-Aufgabe
  • Maskierung: Doppelt

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: Delta tACS

All participants receive delta (2.5 Hz), theta (6 Hz), and sham tACS across three separate sessions, separated by a 7-10 day washout. Session order is randomised and counterbalanced using a balanced Latin square, within each diagnostic group (CUD, MDD, healthy control). Stimulation is interleaved between the 8 blocks of the EEfRT (e.g., block 1 with stimulation, block 2 without, etc.). EEG activity will be recorded throughout the non-stimulation 4 blocks and proceeding interleaved non-stimulation blocks.
Gerät: Transcranial Alternating Current Delta Stimulation.

Approximately 20-minutes of delta stimulation (2.5Hz) applied to F3 (returns AF7, FC5, FC1) and AFz (returns Fp1, Fp2, F2). Transcranial Alternating Current Stimulation Device is NeuroConn DC-Stimulator MC.
Aktiver Komparator: Theta tACS

All participants receive delta (2.5 Hz), theta (6 Hz), and sham tACS across three separate sessions, separated by a 7-10 day washout. Session order is randomised and counterbalanced using a balanced Latin square, within each diagnostic group (CUD, MDD, healthy control). Stimulation is interleaved between the 8 blocks of the EEfRT (e.g., block 1 with stimulation, block 2 without, etc.). EEG activity will be recorded throughout the non-stimulation 4 blocks and proceeding interleaved non-stimulation blocks.
Gerät: Transcranial Alternating Current Theta Stimulation

Approximately 20-minutes of theta stimulation (6Hz) applied to F3 (returns AF7, FC5, FC1) and AFz (returns Fp1, Fp2, F2). Transcranial Alternating Current Stimulation Device is NeuroConn DC-Stimulator MC.
Schein-Komparator: Sham tACS

All participants receive delta (2.5 Hz), theta (6 Hz), and sham tACS across three separate sessions, separated by a 7-10 day washout. Session order is randomised and counterbalanced using a balanced Latin square, within each diagnostic group (CUD, MDD, healthy control). Stimulation is interleaved between the 8 blocks of the EEfRT (e.g., block 1 with stimulation, block 2 without, etc.). EEG activity will be recorded throughout the non-stimulation 4 blocks and proceeding interleaved non-stimulation blocks.
Gerät: Transcranial Alternating Current Stimulation Sham

The tACS stimulation is briefly turned on and off over the course of 15-30 seconds.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Effort-updating behavior during decision period.
Zeitfenster: Baseline (Day 0), Sham Session (Day 1-10, or Day 10-20, or Day 20-30), Theta Stim. Session (Day 1-10, or Day 10-20, or Day 20-30), Delta Stim. Session (Day 1-10, or Day 10-20, or Day 20-30). Specific range depends on particular counterbalanced order.

The % of hard effort choices selected following a win versus following a loss.
Baseline (Day 0), Sham Session (Day 1-10, or Day 10-20, or Day 20-30), Theta Stim. Session (Day 1-10, or Day 10-20, or Day 20-30), Delta Stim. Session (Day 1-10, or Day 10-20, or Day 20-30). Specific range depends on particular counterbalanced order.
Delta phase coherence between left lateral and medial frontal electrodes during decision period following a win versus following a loss.
Zeitfenster: Baseline (Day 0), Sham Session (Day 1-10, or Day 10-20, or Day 20-30), Theta Stim. Session (Day 1-10, or Day 10-20, or Day 20-30), Delta Stim. Session (Day 1-10, or Day 10-20, or Day 20-30). Specific range depends on particular counterbalanced order.

Electrical activity of the brain will be recorded via EEG during performance of the task and neurostimulation. Delta phase connectivity between left lateral and medial frontal electrodes during the decision period following a win versus following a loss.
Baseline (Day 0), Sham Session (Day 1-10, or Day 10-20, or Day 20-30), Theta Stim. Session (Day 1-10, or Day 10-20, or Day 20-30), Delta Stim. Session (Day 1-10, or Day 10-20, or Day 20-30). Specific range depends on particular counterbalanced order.
Reward positivity amplitude
Zeitfenster: Baseline (Day 0), Sham Session (Day 1-10, or Day 10-20, or Day 20-30), Theta Stim. Session (Day 1-10, or Day 10-20, or Day 20-30), Delta Stim. Session (Day 1-10, or Day 10-20, or Day 20-30). Specific range depends on particular counterbalanced order.

Electrical activity of the brain will be recorded via EEG during performance of the task and neurostimulation. Reward positivity amplitude to wins vs. losses.
Baseline (Day 0), Sham Session (Day 1-10, or Day 10-20, or Day 20-30), Theta Stim. Session (Day 1-10, or Day 10-20, or Day 20-30), Delta Stim. Session (Day 1-10, or Day 10-20, or Day 20-30). Specific range depends on particular counterbalanced order.

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Delta event-related spectral power
Zeitfenster: Baseline (Day 0), Sham Session (Day 1-10, or Day 10-20, or Day 20-30), Theta Stim. Session (Day 1-10, or Day 10-20, or Day 20-30), Delta Stim. Session (Day 1-10, or Day 10-20, or Day 20-30). Specific range depends on particular counterbalanced order.

Electrical activity of the brain will be recorded via EEG during performance of the task and neurostimulation. Delta power to wins vs. losses.
Baseline (Day 0), Sham Session (Day 1-10, or Day 10-20, or Day 20-30), Theta Stim. Session (Day 1-10, or Day 10-20, or Day 20-30), Delta Stim. Session (Day 1-10, or Day 10-20, or Day 20-30). Specific range depends on particular counterbalanced order.
Delta intertrial phase coherence
Zeitfenster: Baseline (Day 0), Sham Session (Day 1-10, or Day 10-20, or Day 20-30), Theta Stim. Session (Day 1-10, or Day 10-20, or Day 20-30), Delta Stim. Session (Day 1-10, or Day 10-20, or Day 20-30). Specific range depends on particular counterbalanced order.

Electrical activity of the brain will be recorded via EEG during performance of the task and neurostimulation. Delta intertrial phase coherence to wins vs. losses.
Baseline (Day 0), Sham Session (Day 1-10, or Day 10-20, or Day 20-30), Theta Stim. Session (Day 1-10, or Day 10-20, or Day 20-30), Delta Stim. Session (Day 1-10, or Day 10-20, or Day 20-30). Specific range depends on particular counterbalanced order.

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Florida State University

Ermittler

  • Hauptermittler: Richard J Macatee, Ph.D., Florida State University

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Allgemeine Veröffentlichungen

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Geschätzt)

1. November 2026

Primärer Abschluss (Geschätzt)

1. April 2027

Studienabschluss (Geschätzt)

1. Mai 2027

Studienanmeldedaten

Zuerst eingereicht

26. Oktober 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

3. November 2026

Zuerst gepostet (Tatsächlich)

9. November 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

9. November 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

3. November 2026

Zuletzt verifiziert

1. Oktober 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • STUDY00007710

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

NEIN

Beschreibung des IPD-Plans

The IPD will only be shared under reasonable request. The investigators might not share IPD in order to keep participant confidentiality paramount.

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Ja

Produkt, das in den USA hergestellt und aus den USA exportiert wird

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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