Trial Outcomes & Findings for TMS Alteration of the Reward Positivity (NCT NCT05443256)
NCT ID: NCT05443256
Last Updated: 2024-12-10
Results Overview
EEG Amplitude 200-400 ms following reward receipt
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
9 participants
Primary outcome timeframe
During intervention
Results posted on
2024-12-10
Participant Flow
Participant milestones
| Measure |
Theta Stim
To stimulate fMRI-informed individualized targets in dlPFC to diminish affective modulation of the RewP. Based on our working hypothesis, TMS Figure-8 coil stimulation should diminish affective modulation of RewP amplitude when compared to sham.
Transcranial Magnetic Stimulation: Figure 8 coil stimulation
|
Sham Stim
Sham stimulation. The Reward Positivity should be unaffected.
Transcranial Magnetic Stimulation: Figure 8 coil stimulation
|
|---|---|---|
|
Overall Study
STARTED
|
5
|
4
|
|
Overall Study
COMPLETED
|
4
|
4
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
TMS Alteration of the Reward Positivity
Baseline characteristics by cohort
| Measure |
dlPFC Stimulation
n=4 Participants
To stimulate fMRI-informed individualized targets in dlPFC to diminish affective modulation of the RewP. Based on our working hypothesis, TMS Figure-8 coil stimulation should diminish affective modulation of RewP amplitude when compared to sham.
Transcranial Magnetic Stimulation: Figure 8 coil stimulation
|
dmPFC Stimulation
n=4 Participants
To stimulate individualized targets in dmPFC to alter affective modulation of the RewP. Based on our working hypothesis, TMS Deep Cone stimulation should boost learning-related modulation of RewP amplitude when compared to sham.
Transcranial Magnetic Stimulation: Deep Cone stimulation
|
Total
n=8 Participants
Total of all reporting groups
|
|---|---|---|---|
|
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
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
8 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
|
25.75 years
STANDARD_DEVIATION 5.12 • n=5 Participants
|
29.75 years
STANDARD_DEVIATION 3.77 • n=7 Participants
|
27.75 years
STANDARD_DEVIATION 4.68 • n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
7 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
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 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
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: During interventionEEG Amplitude 200-400 ms following reward receipt
Outcome measures
| Measure |
dlPFC Stimulation
n=4 Participants
To stimulate fMRI-informed individualized targets in dlPFC to diminish affective modulation of the RewP. Based on our working hypothesis, TMS Figure-8 coil stimulation should diminish affective modulation of RewP amplitude when compared to sham.
Transcranial Magnetic Stimulation: Figure 8 coil stimulation
|
dmPFC Stimulation
n=4 Participants
To stimulate individualized targets in dmPFC to alter affective modulation of the RewP. Based on our working hypothesis, TMS Deep Cone stimulation should boost learning-related modulation of RewP amplitude when compared to sham.
Transcranial Magnetic Stimulation: Deep Cone stimulation
|
|---|---|---|
|
Reward Positivity
|
2.21 femtoteslas
Standard Deviation 1.24
|
.29 femtoteslas
Standard Deviation 1.47
|
Adverse Events
dlPFC Stimulation
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
dmPFC Stimulation
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place