AnhedoniaNCT05443256
TMS Alteration of the Reward Positivity
A study testing Transcranial Magnetic Stimulation in people with Anhedonia, run by University of New Mexico at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Anhedonia
- What is being tested?
- Transcranial Magnetic Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2022to 17 Oct 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Men or women aged 18-30
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of New Mexico - Logan hall
Albuquerque, New Mexico, 87106
About this study
Official title: 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).
Read the 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.
- Conditions
- Anhedonia
- Being tested
- Transcranial Magnetic Stimulation
- Medical subject headings
- Anhedonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial Magnetic StimulationDevice
Figure 8 coil stimulation
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Transcranial Magnetic Stimulation |
| Sham Stim | Sham comparator | Sham stimulation. The Reward Positivity should be unaffected. Receives: Device: Transcranial Magnetic Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reward Positivity
EEG Amplitude 200-400 ms following reward receipt
Measured: During intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2022
- Study start1 Aug 2022
- Primary completion17 Nov 2023
- Study completion17 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for AnhedoniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two separate arms of study
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of New Mexico
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, James Cavanagh, University of New Mexico
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05443256
- Sponsor's protocol ID
- 20071
- Status last verified
- Dec 2024
- First submitted
- 29 Jun 2022
- Last updated
- 10 Dec 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Causal Dissociation of Value Contributions to the Reward Positivity
- ClinicalTrials.gov ID
- NCT05443256
- Acronym / sponsor ID
- 20071
- Conditions
- Anhedonia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- University of New MexicoUniversity, hospital or other
- Study start
- 1 Aug 2022 (actual)
- Primary completion
- 17 Nov 2023 (actual)
- Study completion
- 17 Oct 2024 (actual)
- First posted
- 5 Jul 2022 (actual)
- Results
- Posted 10 Dec 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Two separate arms of study
| Arm | Type | Receives |
|---|---|---|
| Theta Stim | Experimental | Device: Transcranial Magnetic StimulationTo 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 Stim | Sham comparator | Device: Transcranial Magnetic StimulationSham stimulation. The Reward Positivity should be unaffected. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Men or women aged 18-30
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcranial Magnetic StimulationFigure 8 coil stimulation | Device | Sham Stim, Theta Stim |
Primary outcome
Reward Positivity
Time frame: During intervention
EEG Amplitude 200-400 ms following reward receipt
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcranial Magnetic Stimulation in people with Anhedonia, run by University of New Mexico at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Dec 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reward Positivity (time frame: During intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Dec 2024.