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NCT05593965: NANCY

Causal Role of Frontostriatal Circuitry in Goal-directed Behavior

Completed NA Results posted Last updated 17 July 2024
What this trial tests

NA trial testing Delta-beta TMS in Executive Function in 24 participants. Completed in 31 July 2023.

Timeline
10 January 2023
Primary endpoint
31 July 2023
31 July 2023

Quick facts

Lead sponsorUniversity of North Carolina, Chapel Hill
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designcrossover
Maskingnone
Primary purposebasic science
Enrollment24
Start date10 January 2023
Primary completion31 July 2023
Estimated completion31 July 2023
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

University of North Carolina, Chapel Hill

Who can join

Adults 18 to 35, any sex, with Executive Function. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Percentage of the Trials That the Participant Chooses to Perform the Hard Task Primary · 2 hours during the 1st intervention and 2 hours during the 2nd intervention

In the Expenditure of Effort for Reward Task, participants are faced with a decision on every trial: to choose an easy task with a low effort exertion for a chance at winning a low amount of money and a hard task with a high effort exertion for a chance at winning a greater amount of money. The incentive for the high effort exertion is changed on each trial and the participant gets physically tired from repeated effort exertion. Goal-directed behavior was calculated as the percentage of trials in which the participant decides to perform the most difficult effort exertion task in the Expenditur

GroupValue95% CI
Delta-beta TMS to Lateral Prefrontal Cortex33.2± 22.2
Theta-gamma TMS to Lateral Prefrontal Cortex32.9± 20.1
Arrhythmic TMS to Lateral Prefrontal Cortex33.6± 21.0
Delta-beta TMS to Medial Prefrontal Cortex37.1± 21.6
Theta-gamma TMS to Medial Prefrontal Cortex37.1± 21.9
Arrhythmic TMS to Medial Prefrontal Cortex37.6± 19.5
Coupling Strength Between Low-frequency Prefrontal Signals and High-frequency Posterior Signals Secondary · 2 hours during the 1st intervention and 2 hours during the 2nd intervention

Phase-amplitude coupling strength is calculated using the mean vector length metric between low-frequency activity in prefrontal electrodes and high-frequency activity in motor electrodes. A Z-score indicates the number of standard deviations away from the mean of distribution generated by randomly time-shifting the data. A Z-score of 0 is equal to the mean coupling strength of random data. Higher values are greater coupling strength. Positive values (\> 1) indicate increased prefrontal control over the motor cortex, which is found in healthy individuals during decision-making.

GroupValue95% CI
Delta-beta TMS to Lateral Prefrontal Cortex0.416± 1.073
Theta-gamma TMS to Lateral Prefrontal Cortex0.008± 1.214
Arrhythmic TMS to Lateral Prefrontal Cortex0.308± 1.112
Delta-beta TMS to Medial Prefrontal Cortex-0.051± 1.241
Theta-gamma TMS to Medial Prefrontal Cortex-0.094± 0.850
Arrhythmic TMS to Medial Prefrontal Cortex0.274± 1.027

Adverse events — posted to ClinicalTrials.gov

Time frame: Adverse events were monitored during the first and second intervention, a total of four hours across 1 week. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

TMS to Lateral Prefrontal Cortex
Serious: 0/24 (0%)
Deaths: 0/24
TMS to Medial Prefrontal Cortex
Serious: 0/23 (0%)
Deaths: 0/23
Other adverse events (1 terms — click to expand)

ReactionSystemTMS to Lateral Prefrontal …TMS to Medial Prefrontal C…
Trouble concentratingNervous system disorders

Data from ClinicalTrials.gov NCT05593965 adverse events section.

Sponsor's own description

The purpose of this clinical trial is to investigate the causal role that frontostriatal circuitry plays in goal-directed behavior. The participants will perform a reward-based decision-making task. During the task, cross-frequency patterned rhythmic transcranial magnetic stimulation (TMS) will be delivered at delta-beta frequency, a control-frequency, or an active sham to either the dorsolateral or medial prefrontal cortex (PFC). Electroencephalography will be collected concurrent with stimulation. Structural and functional magnetic resonance imaging (MRI) will be collected during performance of the reward-based decision-making task to localize the stimulation targets.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

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Other recruiting trials for Executive Function

Currently open trials in the same condition.

Other University of North Carolina, Chapel Hill trials

Trials by the same sponsor.

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05593965.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing