NCT05443256

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
9

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 29, 2022

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 5, 2022

Completed
27 days until next milestone

Study Start

First participant enrolled

August 1, 2022

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 17, 2023

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 17, 2024

Completed
2 months until next milestone

Results Posted

Study results publicly available

December 10, 2024

Completed
Last Updated

December 10, 2024

Status Verified

December 1, 2024

Enrollment Period

1.3 years

First QC Date

June 29, 2022

Results QC Date

November 6, 2024

Last Update Submit

December 5, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Reward Positivity

    EEG Amplitude 200-400 ms following reward receipt

    During intervention

Study Arms (2)

Theta Stim

EXPERIMENTAL

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.

Device: Transcranial Magnetic Stimulation

Sham Stim

SHAM COMPARATOR

Sham stimulation. The Reward Positivity should be unaffected.

Device: Transcranial Magnetic Stimulation

Interventions

Figure 8 coil stimulation

Sham StimTheta Stim

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Men or women aged 18-30

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of New Mexico - Logan hall

Albuquerque, New Mexico, 87106, United States

Location

MeSH Terms

Conditions

Anhedonia

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Neurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Magnetic Field TherapyTherapeutics

Results Point of Contact

Title
Dr. James F. Cavanagh
Organization
University of New Mexico

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: Two separate arms of study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

June 29, 2022

First Posted

July 5, 2022

Study Start

August 1, 2022

Primary Completion

November 17, 2023

Study Completion

October 17, 2024

Last Updated

December 10, 2024

Results First Posted

December 10, 2024

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will not share

Locations