- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05443256
TMS Alteration of the Reward Positivity
January 31, 2024 updated by: James Cavanagh, University of New Mexico
Causal Dissociation of Value Contributions to the Reward Positivity
The aim of this proposal is to demonstrate that stimulation of different brain regions differently affects the electroencephalographic feature known as the Reward Positivity (RewP).
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Detailed Description
The aim of this proposal is to demonstrate that stimulation of different brain regions differently affects the electroencephalographic feature known as the Reward Positivity (RewP).
The RewP is a sensitive and specific biomarker of reward receipt.
This proposal will advance a causal test of the hypothesis that there are two major sources of variance that contribute to this brain response: a dorsal midline contribution to information encoding and a ventral midline contribution that is modulated by affect.
Together, these findings will reveal how the RewP acts to blend multiple aspects of value together in the service of motivated learning.
The objective of this proposal is to gather pilot data to demonstrate the feasibility of using transcranial magnetic stimulation (TMS) to perturb idiosyncratically-defined (fMRI-based) dorsal or ventral targets in order to causally test the hypothesis that these different sources contribute different types of variance to the RewP.
TMS double cone deep coil stimulation should diminish +RPE encoding in the RewP when compared to sham.
TMS Figure-8 coil stimulation should diminish affective modulation of RewP amplitude when compared to sham.
Study Type
Interventional
Enrollment (Estimated)
8
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: James Cavanagh, PhD
- Phone Number: 5052776830
- Email: jcavanagh@unm.edu
Study Locations
-
-
New Mexico
-
Albuquerque, New Mexico, United States, 87106
- Recruiting
- University of New Mexico - Logan hall
-
Contact:
- james F Cavanagh, PhD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 28 years (Adult)
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
• Men or women aged 18-30
Exclusion Criteria:
- Participants unwilling or unable to give informed consent
- Presence of other known medical or psychiatric comorbidity that in the investigator's opinion would compromise participation in the study
- MEG/MRI contraindications
- History of psychosis
- Not fluent in English
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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.
|
Figure 8 coil stimulation
|
Sham Comparator: Sham Stim
Sham stimulation.
The Reward Positivity should be unaffected.
|
Figure 8 coil stimulation
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Reward Positivity
Time Frame: During intervention
|
EEG Amplitude 200-400 ms following reward receipt
|
During intervention
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 1, 2022
Primary Completion (Estimated)
December 31, 2024
Study Completion (Estimated)
December 31, 2024
Study Registration Dates
First Submitted
June 29, 2022
First Submitted That Met QC Criteria
June 29, 2022
First Posted (Actual)
July 5, 2022
Study Record Updates
Last Update Posted (Estimated)
February 1, 2024
Last Update Submitted That Met QC Criteria
January 31, 2024
Last Verified
January 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 20071
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
Yes
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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