Trial Outcomes & Findings for Causal Role of Frontostriatal Circuitry in Goal-directed Behavior (NCT NCT05593965)
NCT ID: NCT05593965
Last Updated: 2024-07-17
Results Overview
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 Expenditure of Effort for Reward Task. A higher percentage equates to more goal-directed behavior and is favorable.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
24 participants
Primary outcome timeframe
2 hours during the 1st intervention and 2 hours during the 2nd intervention
Results posted on
2024-07-17
Participant Flow
Participant milestones
| Measure |
TMS to Lateral Prefrontal Cortex Followed by TMS to Medial Prefrontal Cortex
Participants will receive transcranial magnetic stimulation (TMS) while performing a reward-based decision-making task. In the first stimulation session, the TMS coil will be placed over the lateral prefrontal cortex on the scalp. In the second session, the TMS coil will be placed over the medial prefrontal cortex on the scalp. during every session, subjects receive Delta-beta patterned TMS, Theta-gamma patterned TMS, and Arrhythmic TMS.
Delta-beta TMS: TMS will be delivered in a delta-beta pattern in which triplets of pulses delivered at 20 Hz (50 milliseconds between each pulse) are sent every 3 Hz (333 milliseconds between the start of each triplet).
Theta-gamma TMS: TMS will be delivered in a theta-gamma pattern in which triplets of pulses delivered at 50 Hz (20 milliseconds between each pulse) are sent every 5 Hz (200 milliseconds between the start of each triplet).
Arrhythmic TMS: TMS will be delivered in an arrhythmic pattern in which pulses are delivered with a random inter-pulse interval. The number of pulses and duration is matched to that of the Delta-beta TMS and Theta-gamma TMS.
|
TMS to Medial Prefrontal Cortex Followed by TMS to Lateral Prefrontal Cortex
Participants will receive TMS while performing a reward-based decision-making task. In the first stimulation session, the TMS coil will be placed over the medial prefrontal cortex on the scalp. In the second session, the TMS coil will be placed over the lateral prefrontal cortex on the scalp. during every session, subjects receive Delta-beta patterned TMS, Theta-gamma patterned TMS, and Arrhythmic TMS.
Delta-beta TMS: TMS will be delivered in a delta-beta pattern in which triplets of pulses delivered at 20 Hz (50 milliseconds between each pulse) are sent every 3 Hz (333 milliseconds between the start of each triplet).
Theta-gamma TMS: TMS will be delivered in a theta-gamma pattern in which triplets of pulses delivered at 50 Hz (20 milliseconds between each pulse) are sent every 5 Hz (200 milliseconds between the start of each triplet).
Arrhythmic TMS: TMS will be delivered in an arrhythmic pattern in which pulses are delivered with a random inter-pulse interval. The number of pulses and duration is matched to that of the Delta-beta TMS and Theta-gamma TMS.
|
|---|---|---|
|
1st Intervention (1 Day)
STARTED
|
17
|
7
|
|
1st Intervention (1 Day)
COMPLETED
|
16
|
7
|
|
1st Intervention (1 Day)
NOT COMPLETED
|
1
|
0
|
|
2nd Intervention (1 Day)
STARTED
|
16
|
7
|
|
2nd Intervention (1 Day)
COMPLETED
|
16
|
7
|
|
2nd Intervention (1 Day)
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
| Measure |
TMS to Lateral Prefrontal Cortex Followed by TMS to Medial Prefrontal Cortex
Participants will receive transcranial magnetic stimulation (TMS) while performing a reward-based decision-making task. In the first stimulation session, the TMS coil will be placed over the lateral prefrontal cortex on the scalp. In the second session, the TMS coil will be placed over the medial prefrontal cortex on the scalp. during every session, subjects receive Delta-beta patterned TMS, Theta-gamma patterned TMS, and Arrhythmic TMS.
Delta-beta TMS: TMS will be delivered in a delta-beta pattern in which triplets of pulses delivered at 20 Hz (50 milliseconds between each pulse) are sent every 3 Hz (333 milliseconds between the start of each triplet).
Theta-gamma TMS: TMS will be delivered in a theta-gamma pattern in which triplets of pulses delivered at 50 Hz (20 milliseconds between each pulse) are sent every 5 Hz (200 milliseconds between the start of each triplet).
Arrhythmic TMS: TMS will be delivered in an arrhythmic pattern in which pulses are delivered with a random inter-pulse interval. The number of pulses and duration is matched to that of the Delta-beta TMS and Theta-gamma TMS.
|
TMS to Medial Prefrontal Cortex Followed by TMS to Lateral Prefrontal Cortex
Participants will receive TMS while performing a reward-based decision-making task. In the first stimulation session, the TMS coil will be placed over the medial prefrontal cortex on the scalp. In the second session, the TMS coil will be placed over the lateral prefrontal cortex on the scalp. during every session, subjects receive Delta-beta patterned TMS, Theta-gamma patterned TMS, and Arrhythmic TMS.
Delta-beta TMS: TMS will be delivered in a delta-beta pattern in which triplets of pulses delivered at 20 Hz (50 milliseconds between each pulse) are sent every 3 Hz (333 milliseconds between the start of each triplet).
Theta-gamma TMS: TMS will be delivered in a theta-gamma pattern in which triplets of pulses delivered at 50 Hz (20 milliseconds between each pulse) are sent every 5 Hz (200 milliseconds between the start of each triplet).
Arrhythmic TMS: TMS will be delivered in an arrhythmic pattern in which pulses are delivered with a random inter-pulse interval. The number of pulses and duration is matched to that of the Delta-beta TMS and Theta-gamma TMS.
|
|---|---|---|
|
1st Intervention (1 Day)
Technical error
|
1
|
0
|
Baseline Characteristics
Causal Role of Frontostriatal Circuitry in Goal-directed Behavior
Baseline characteristics by cohort
| Measure |
TMS to Lateral Prefrontal Cortex Followed by TMS to Medial Prefrontal Cortex
n=17 Participants
Participants will receive TMS while performing a reward-based decision-making task. In the first stimulation session, the TMS coil will be placed over the lateral prefrontal cortex on the scalp. In the second session, the TMS coil will be placed over the medial prefrontal cortex on the scalp. during every session, subjects receive Delta-beta patterned TMS, Theta-gamma patterned TMS, and Arrhythmic TMS.
Delta-beta TMS: TMS will be delivered in a delta-beta pattern in which triplets of pulses delivered at 20 Hz (50 milliseconds between each pulse) are sent every 3 Hz (333 milliseconds between the start of each triplet).
Theta-gamma TMS: TMS will be delivered in a theta-gamma pattern in which triplets of pulses delivered at 50 Hz (20 milliseconds between each pulse) are sent every 5 Hz (200 milliseconds between the start of each triplet).
Arrhythmic TMS: TMS will be delivered in an arrhythmic pattern in which pulses are delivered with a random inter-pulse interval. The number of pulses and duration is matched to that of the Delta-beta TMS and Theta-gamma TMS.
|
TMS to Medial Prefrontal Cortex Followed by TMS to Lateral Prefrontal Cortex
n=7 Participants
Participants will receive TMS while performing a reward-based decision-making task. In the first stimulation session, the TMS coil will be placed over the medial prefrontal cortex on the scalp. In the second session, the TMS coil will be placed over the lateral prefrontal cortex on the scalp. during every session, subjects receive Delta-beta patterned TMS, Theta-gamma patterned TMS, and Arrhythmic TMS.
Delta-beta TMS: TMS will be delivered in a delta-beta pattern in which triplets of pulses delivered at 20 Hz (50 milliseconds between each pulse) are sent every 3 Hz (333 milliseconds between the start of each triplet).
Theta-gamma TMS: TMS will be delivered in a theta-gamma pattern in which triplets of pulses delivered at 50 Hz (20 milliseconds between each pulse) are sent every 5 Hz (200 milliseconds between the start of each triplet).
Arrhythmic TMS: TMS will be delivered in an arrhythmic pattern in which pulses are delivered with a random inter-pulse interval. The number of pulses and duration is matched to that of the Delta-beta TMS and Theta-gamma TMS.
|
Total
n=24 Participants
Total of all reporting groups
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|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
17 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
21.4 years
STANDARD_DEVIATION 4.4 • n=5 Participants
|
23.3 years
STANDARD_DEVIATION 6.0 • n=7 Participants
|
22.0 years
STANDARD_DEVIATION 4.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
17 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
8 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
8 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
17 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Percentage of the Trials That the Participant Chooses to Perform the Hard Task
|
54.0 percentage of trials
STANDARD_DEVIATION 12.8 • n=5 Participants
|
56.9 percentage of trials
STANDARD_DEVIATION 11.2 • n=7 Participants
|
54.8 percentage of trials
STANDARD_DEVIATION 12.2 • n=5 Participants
|
|
Coupling Strength Between Low-frequency Prefrontal Signals and High-frequency Posterior Signals
|
0.414 Z-score
STANDARD_DEVIATION 1.071 • n=5 Participants
|
-0.179 Z-score
STANDARD_DEVIATION 1.401 • n=7 Participants
|
0.345 Z-score
STANDARD_DEVIATION 1.106 • n=5 Participants
|
PRIMARY outcome
Timeframe: 2 hours during the 1st intervention and 2 hours during the 2nd interventionIn 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 Expenditure of Effort for Reward Task. A higher percentage equates to more goal-directed behavior and is favorable.
Outcome measures
| Measure |
Delta-beta TMS to Lateral Prefrontal Cortex
n=23 Participants
Participants received delta-beta TMS to lateral prefrontal cortex while performing a reward-based decision-making task. Delta-beta TMS: TMS will be delivered in a delta-beta pattern in which triplets of pulses delivered at 20 Hz (50 milliseconds between each pulse) are sent every 3 Hz (333 milliseconds between the start of each triplet).
|
Theta-gamma TMS to Lateral Prefrontal Cortex
n=23 Participants
Participants received theta-gamma TMS to lateral prefrontal cortex while performing a reward-based decision-making task. Theta-gamma TMS: TMS will be delivered in a theta-gamma pattern in which triplets of pulses delivered at 50 Hz (20 milliseconds between each pulse) are sent every 5 Hz (200 milliseconds between the start of each triplet).
|
Arrhythmic TMS to Lateral Prefrontal Cortex
n=23 Participants
Participants received arrhythmic TMS to lateral prefrontal cortex while performing a reward-based decision-making task. Arrhythmic TMS: TMS will be delivered in an arrhythmic pattern in which pulses are delivered with a random inter-pulse interval. The number of pulses and duration is matched to that of the Delta-beta TMS and Theta-gamma TMS.
|
Delta-beta TMS to Medial Prefrontal Cortex
n=23 Participants
Participants received delta-beta TMS to medial prefrontal cortex while performing a reward-based decision-making task. Delta-beta TMS: TMS will be delivered in a delta-beta pattern in which triplets of pulses delivered at 20 Hz (50 milliseconds between each pulse) are sent every 3 Hz (333 milliseconds between the start of each triplet).
|
Theta-gamma TMS to Medial Prefrontal Cortex
n=23 Participants
Participants received theta-gamma TMS to medial prefrontal cortex while performing a reward-based decision-making task. Theta-gamma TMS: TMS will be delivered in a theta-gamma pattern in which triplets of pulses delivered at 50 Hz (20 milliseconds between each pulse) are sent every 5 Hz (200 milliseconds between the start of each triplet).
|
Arrhythmic TMS to Medial Prefrontal Cortex
n=23 Participants
Participants received arrhythmic TMS to medial prefrontal cortex while performing a reward-based decision-making task. Arrhythmic TMS: TMS will be delivered in an arrhythmic pattern in which pulses are delivered with a random inter-pulse interval. The number of pulses and duration is matched to that of the Delta-beta TMS and Theta-gamma TMS.
|
|---|---|---|---|---|---|---|
|
Percentage of the Trials That the Participant Chooses to Perform the Hard Task
|
33.2 Percentage of trials
Standard Deviation 22.2
|
32.9 Percentage of trials
Standard Deviation 20.1
|
33.6 Percentage of trials
Standard Deviation 21.0
|
37.1 Percentage of trials
Standard Deviation 21.6
|
37.1 Percentage of trials
Standard Deviation 21.9
|
37.6 Percentage of trials
Standard Deviation 19.5
|
SECONDARY outcome
Timeframe: 2 hours during the 1st intervention and 2 hours during the 2nd interventionPhase-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.
Outcome measures
| Measure |
Delta-beta TMS to Lateral Prefrontal Cortex
n=23 Participants
Participants received delta-beta TMS to lateral prefrontal cortex while performing a reward-based decision-making task. Delta-beta TMS: TMS will be delivered in a delta-beta pattern in which triplets of pulses delivered at 20 Hz (50 milliseconds between each pulse) are sent every 3 Hz (333 milliseconds between the start of each triplet).
|
Theta-gamma TMS to Lateral Prefrontal Cortex
n=23 Participants
Participants received theta-gamma TMS to lateral prefrontal cortex while performing a reward-based decision-making task. Theta-gamma TMS: TMS will be delivered in a theta-gamma pattern in which triplets of pulses delivered at 50 Hz (20 milliseconds between each pulse) are sent every 5 Hz (200 milliseconds between the start of each triplet).
|
Arrhythmic TMS to Lateral Prefrontal Cortex
n=23 Participants
Participants received arrhythmic TMS to lateral prefrontal cortex while performing a reward-based decision-making task. Arrhythmic TMS: TMS will be delivered in an arrhythmic pattern in which pulses are delivered with a random inter-pulse interval. The number of pulses and duration is matched to that of the Delta-beta TMS and Theta-gamma TMS.
|
Delta-beta TMS to Medial Prefrontal Cortex
n=23 Participants
Participants received delta-beta TMS to medial prefrontal cortex while performing a reward-based decision-making task. Delta-beta TMS: TMS will be delivered in a delta-beta pattern in which triplets of pulses delivered at 20 Hz (50 milliseconds between each pulse) are sent every 3 Hz (333 milliseconds between the start of each triplet).
|
Theta-gamma TMS to Medial Prefrontal Cortex
n=23 Participants
Participants received theta-gamma TMS to medial prefrontal cortex while performing a reward-based decision-making task. Theta-gamma TMS: TMS will be delivered in a theta-gamma pattern in which triplets of pulses delivered at 50 Hz (20 milliseconds between each pulse) are sent every 5 Hz (200 milliseconds between the start of each triplet).
|
Arrhythmic TMS to Medial Prefrontal Cortex
n=23 Participants
Participants received arrhythmic TMS to medial prefrontal cortex while performing a reward-based decision-making task. Arrhythmic TMS: TMS will be delivered in an arrhythmic pattern in which pulses are delivered with a random inter-pulse interval. The number of pulses and duration is matched to that of the Delta-beta TMS and Theta-gamma TMS.
|
|---|---|---|---|---|---|---|
|
Coupling Strength Between Low-frequency Prefrontal Signals and High-frequency Posterior Signals
|
0.416 Z-score
Standard Deviation 1.073
|
0.008 Z-score
Standard Deviation 1.214
|
0.308 Z-score
Standard Deviation 1.112
|
-0.051 Z-score
Standard Deviation 1.241
|
-0.094 Z-score
Standard Deviation 0.850
|
0.274 Z-score
Standard Deviation 1.027
|
Adverse Events
TMS to Lateral Prefrontal Cortex
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
TMS to Medial Prefrontal Cortex
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
TMS to Lateral Prefrontal Cortex
n=24 participants at risk
Participants received TMS to the lateral prefrontal cortex while performing a reward-based decision-making task.
|
TMS to Medial Prefrontal Cortex
n=23 participants at risk
Participants received TMS to the medial prefrontal cortex while performing a reward-based decision-making task.
|
|---|---|---|
|
Nervous system disorders
Trouble concentrating
|
4.2%
1/24 • Number of events 1 • Adverse events were monitored during the first and second intervention, a total of four hours across 1 week
In this cross-over design, the interventions were administered in a block design such that each block included the same type of stimulation (delta-beta, theta-gamma, or arrhythmic patterned). Adverse events were assessed at the end of the session. Thus, there are adverse events reported for each stimulation location (lateral prefrontal cortex or medial prefrontal cortex), but there is no way to determine which of the patterns of stimulation might be more or less related to the adverse events.
|
0.00%
0/23 • Adverse events were monitored during the first and second intervention, a total of four hours across 1 week
In this cross-over design, the interventions were administered in a block design such that each block included the same type of stimulation (delta-beta, theta-gamma, or arrhythmic patterned). Adverse events were assessed at the end of the session. Thus, there are adverse events reported for each stimulation location (lateral prefrontal cortex or medial prefrontal cortex), but there is no way to determine which of the patterns of stimulation might be more or less related to the adverse events.
|
Additional Information
Justin Riddle, PhD
University of North Carolina at Chapel Hill
Phone: (919) 966-4584
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place