Back to resultsTMS Alteration of the Reward Positivity
Primary Purpose
Anhedonia
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Transcranial Magnetic Stimulation
Sponsored by
About this trial
This is an interventional other trial for Anhedonia
Eligibility Criteria
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
Sites / Locations
- University of New Mexico - Logan hallRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
Theta Stim
Sham Stim
Arm Description
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.
Sham stimulation. The Reward Positivity should be unaffected.
Outcomes
Primary Outcome Measures
Reward Positivity
EEG Amplitude 200-400 ms following reward receipt
Secondary Outcome Measures
Full Information
NCT ID
NCT05443256
First Posted
June 29, 2022
Last Updated
August 28, 2023
Sponsor
University of New Mexico
1. Study Identification
Unique Protocol Identification Number
NCT05443256
Brief Title
TMS Alteration of the Reward Positivity
Official Title
Causal Dissociation of Value Contributions to the Reward Positivity
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 1, 2022 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of New Mexico
4. Oversight
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
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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).
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anhedonia
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Two separate arms of study
Masking
Participant
Allocation
Randomized
Enrollment
8 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Theta Stim
Arm Type
Experimental
Arm Description
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.
Arm Title
Sham Stim
Arm Type
Sham Comparator
Arm Description
Sham stimulation. The Reward Positivity should be unaffected.
Intervention Type
Device
Intervention Name(s)
Transcranial Magnetic Stimulation
Intervention Description
Figure 8 coil stimulation
Primary Outcome Measure Information:
Title
Reward Positivity
Description
EEG Amplitude 200-400 ms following reward receipt
Time Frame
During intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
James Cavanagh, PhD
Phone
5052776830
Email
jcavanagh@unm.edu
Facility Information:
Facility Name
University of New Mexico - Logan hall
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87106
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
james F Cavanagh, PhD
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
TMS Alteration of the Reward Positivity
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