Left Rostromedial Prefrontal Cortex - Accelerated Intermittent Theta BurstrmPFC-SavoringNCT07467473
Causal Role of Rostromedial Prefrontal Cortex for Positive Savoring in Depression
A study testing Accelerated Intermittent Theta Burst Transcranial Magnetic Stimulation in people with Left Rostromedial Prefrontal Cortex - Accelerated Intermittent Theta Burst and Left Dorsolateral Prefrontal Cortex - Accelerated Intermittent Theta Burst, run by Florida State University at 1 site in United States.
Trial summary
This is a non-invasive brain stimulation and neuroimaging study that will examine how activity in the medial prefrontal cortex influences reward processing, particularly positive savoring, in individuals with depression. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Left Rostromedial Prefrontal Cortex - Accelerated Intermittent Theta Burst, Left Dorsolateral Prefrontal Cortex - Accelerated Intermittent Theta Burst, Left Primary Somatosensory Cortex - Accelerated Intermittent Theta Burst
- What is being tested?
- Accelerated Intermittent Theta Burst Transcranial Magnetic Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Mar 2026to 31 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Between the ages of 18 and 65
- Able to provide informed consent
- Have normal or corrected vision
- Right handed
- Willing to comply with all study procedures and be available for the duration of the study
- Speak and understand English
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- Not color blind
- Acceptable suicide risk as determined by less than 5 on the Depression Symptom Index Suicidality Subscale (DSI-SS)
- A diagnosis of major depressive disorder (current episode) on the Structured Clinical Interview for the DSM-5 (SCID-5)
- Between the ages of 18 and 65
Who cannot join
- ADHD (currently under treatment)
- Neurological disorders and conditions. Including but not limited to: history of epilepsy, seizures (except childhood febrile seizures), dementia, history of stroke, Parkindon's disease, multiple sclerosis, cerebral aneurysm, brain tumors
- Medical or neurological illness or treatment for a medical disorder that could interfere with study participation. For example, unstable cardiac disease, HIV/AIDS, malignancy, liver or renal impairment
- Prior brain surgery
- Any brain devices/implants, including cochlear implants and aneurysm clips, cardiac pacemaker, or any other implanted electronic device
- History of current traumatic brain injury
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- Pregnancy (for females)
- Claustrophobia
- DSM-5 diagnosis of present moderate or severe substance use disorder or alcohol use disorder, and past severe substance use disorder or alcohol use disorder, bipolar disorder, or psychotic disorder
- Based on the use of MRI, additional exclusion criteria are considered. These include participants having ferrous metal in their body, having non-removable jewelry that is ferrous, having tattoos on the face or neck, history of being a metal worker or having an eye injury involving metal
- Anything that in the opinion of the investigator would place the participant at increased risk or preclude the participant's full compliance with or completion of the study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Florida State University
Tallahassee, Florida, 32306
About this study
This is a non-invasive brain stimulation and neuroimaging study that will examine how activity in the medial prefrontal cortex influences reward processing, particularly positive savoring, in individuals with depression. The central question is whether modulating medial prefrontal brain regions using transcranial magnetic stimulation (TMS) alters neural and behavioral responses to rewards. Brain activity will be recorded using both electroencephalography (EEG) and functional magnetic resonance imaging (fMRI) while participants perform reward tasks. The primary objectives are to (1) identify patterns of brain activity linked to impaired reward processing in depression using EEG and fMRI, and (2) determine the causal role of specific prefrontal areas in these processes through targeted TMS. The methods include four sessions over four weeks: a clinical assessment, EEG recording during reward tasks after participants learn/practice positive savoring, an fMRI session, and a TMS session combined with EEG while participants practice positive savoring and perform reward tasks during EEG.
- Conditions
- Left Rostromedial Prefrontal Cortex - Accelerated Intermittent Theta Burst, Left Dorsolateral Prefrontal Cortex - Accelerated Intermittent Theta Burst, Left Primary Somatosensory Cortex - Accelerated Intermittent Theta Burst
- Being tested
- Accelerated Intermittent Theta Burst Transcranial Magnetic Stimulation
- Keywords
- Transcranial Magnetic Stimulation, Major Depressive Disorder, Positive Affect, Anhedonia, Savoring
- Medical subject headings
- Depressive Disorder, Major, Anhedonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Accelerated Intermittent Theta Burst Transcranial Magnetic StimulationDevice
For accelerated intermittent theta burst stimulation (aiTBS), stimulation intensity will be set at 80% resting motor threshold (rMT), a level that has been established to be safe and effective. aiTBS will consist of bursts containing 3 pulses at 50 Hz. Bursts will be delivered at 5 Hz for 2 seconds at 80% of rMT, followed by 8 seconds without stimulation. This pattern will continue for 60 cycles (1800 pulses), for a total elapsed time of 10 minutes. Participants will be randomized to receive aiTBS to their mPFC, dlPFC, or primary somatosensory cortex (S1) a total of two times in a single session for 10 minutes each (spaced 50 minutes apart) before/after EEG preparation and practicing a positive affect technique (i.e., savoring), and before performing a positive savoring and reward responsivity task during EEG.
| Study group | Role | What they receive |
|---|---|---|
| Left Rostromedial Prefrontal Cortex - Accelerated Intermittent Theta Burst | Experimental | Accelerated intermittent theta burst will be delivered to left rostromedial prefrontal cortex, which has been previously shown to manipulate reward sensitivity. We are testing if this also impacts positive savoring as measured by the late positive potential during EEG and positive affect. This is an experimental condition that will be compared to an active comparator and a sham comparator. Receives: Device: Accelerated Intermittent Theta Burst Transcranial Magnetic Stimulation |
| Left Dorsolateral Prefrontal Cortex - Accelerated Intermittent Theta Burst | Active comparator | Accelerated intermittent theta burst will be delivered to left dorsolateral prefrontal cortex, which is considered "treatment as usual" for depression. Receives: Device: Accelerated Intermittent Theta Burst Transcranial Magnetic Stimulation |
| Left Primary Somatosensory Cortex - Accelerated Intermittent Theta Burst | Placebo comparator | Accelerated intermittent theta burst will be delivered to left primary somatosensory cortex, which is a placebo intervention condition. Receives: Device: Accelerated Intermittent Theta Burst Transcranial Magnetic Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Late Positive Potential during Positive Savoring
The late positive potential (LPP) is an established event-related potential that has been shown to be higher when savoring positive feelings elicited by positive images compared to neutral images. Changes in the LPP will be assessed from baseline EEG to post-stimulation EEG and compared between stimulation sites (left rostromedial PFC, left dorsolateral PFC, left primary somatosensory cortex).
Measured: From baseline EEG to post-stimulation EEG approximately 2 weeks apart
Secondary outcomes (1)
Positive Affect Ratings on the Positive and Negative Affect Schedule (PANAS)
Positive Affect subscale ratings on the Positive and Negative Affect Schedule (PANAS) self-report measure will be collected at the start and end of the stimulation visit, which will be used to assess the secondary outcome of acute positive affect change. The full PANAS measure includes 20 items with Negative Affect (NA) and Positive Affect (PA) subscales of 10 items each. Scores can range from 10-50, with higher scores representing higher levels of either NA or PA. This will be compared across the three stimulation sites.
Measured: From the start to the end of a 3 hour study visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2026
- Study start23 Mar 2026
- Primary completion30 Jun 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Left Rostromedial Prefrontal Cortex - Accelerated Intermittent Theta BurstStudies of the same condition, open and under way.
- More trials run by Florida State UniversityThe sponsor's other registered studies.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel randomized and active controlled study. Participants will be randomized to receive accelerated intermittent theta burst stimulation to one of three target brain regions (left rostromedial PFC, left dorsolateral PFC, or left primary somatosensory cortex).
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Florida State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Justin Riddle, Florida State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07467473
- Sponsor's protocol ID
- STUDY00006827
- Acronym
- rmPFC-Savoring
- Status last verified
- May 2026
- First submitted
- 9 Mar 2026
- Last updated
- 20 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with FSU.
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Causal Role of Rostromedial Prefrontal Cortex for Positive Savoring in Depression
- ClinicalTrials.gov ID
- NCT07467473
- Acronym / sponsor ID
- rmPFC-Savoring / STUDY00006827
- Conditions
- Left Rostromedial Prefrontal Cortex - Accelerated Intermittent Theta Burst, Left Dorsolateral Prefrontal Cortex - Accelerated Intermittent Theta Burst, Left Primary Somatosensory Cortex - Accelerated Intermittent Theta Burst
- Keywords
- Transcranial Magnetic Stimulation, Major Depressive Disorder, Positive Affect, Anhedonia, Savoring
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Florida State UniversityUniversity, hospital or other
- Study start
- 23 Mar 2026 (actual)
- Primary completion
- 30 Jun 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 12 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a non-invasive brain stimulation and neuroimaging study that will examine how activity in the medial prefrontal cortex influences reward processing, particularly positive savoring, in individuals with depression. The central question is whether modulating medial prefrontal brain regions using transcranial magnetic stimulation (TMS) alters neural and behavioral responses to rewards. Brain activity will be recorded using both electroencephalography (EEG) and functional magnetic resonance imaging (fMRI) while participants perform reward tasks. The primary objectives are to (1) identify patterns of brain activity linked to impaired reward processing in depression using EEG and fMRI, and (2) determine the causal role of specific prefrontal areas in these processes through targeted TMS. The methods include four sessions over four weeks: a clinical assessment, EEG recording during reward tasks after participants learn/practice positive savoring, an fMRI session, and a TMS session combined with EEG while participants practice positive savoring and perform reward tasks during EEG.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- Parallel randomized and active controlled study. Participants will be randomized to receive accelerated intermittent theta burst stimulation to one of three target brain regions (left rostromedial PFC, left dorsolateral PFC, or left primary somatosensory cortex).
| Arm | Type | Receives |
|---|---|---|
| Left Rostromedial Prefrontal Cortex - Accelerated Intermittent Theta Burst | Experimental | Device: Accelerated Intermittent Theta Burst Transcranial Magnetic StimulationAccelerated intermittent theta burst will be delivered to left rostromedial prefrontal cortex, which has been previously shown to manipulate reward sensitivity. We are testing if this also impacts positive savoring as measured by the late positive potential during EEG and positive affect. This is an experimental condition that will be compared to an active comparator and a sham comparator. |
| Left Dorsolateral Prefrontal Cortex - Accelerated Intermittent Theta Burst | Active comparator | Device: Accelerated Intermittent Theta Burst Transcranial Magnetic StimulationAccelerated intermittent theta burst will be delivered to left dorsolateral prefrontal cortex, which is considered "treatment as usual" for depression. |
| Left Primary Somatosensory Cortex - Accelerated Intermittent Theta Burst | Placebo comparator | Device: Accelerated Intermittent Theta Burst Transcranial Magnetic StimulationAccelerated intermittent theta burst will be delivered to left primary somatosensory cortex, which is a placebo intervention condition. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Between the ages of 18 and 65
- Able to provide informed consent
- Have normal or corrected vision
- Right handed
- Willing to comply with all study procedures and be available for the duration of the study
Key exclusion criteria (11 listed)
- ADHD (currently under treatment)
- Neurological disorders and conditions. Including but not limited to: history of epilepsy, seizures (except childhood febrile seizures), dementia, history of stroke, Parkindon's disease, multiple sclerosis, cerebral aneurysm, brain tumors
- Medical or neurological illness or treatment for a medical disorder that could interfere with study participation. For example, unstable cardiac disease, HIV/AIDS, malignancy, liver or renal impairment
- Prior brain surgery
- Any brain devices/implants, including cochlear implants and aneurysm clips, cardiac pacemaker, or any other implanted electronic device
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 |
|---|---|---|
| Accelerated Intermittent Theta Burst Transcranial Magnetic StimulationFor accelerated intermittent theta burst stimulation (aiTBS), stimulation intensity will be set at 80% resting motor threshold (rMT), a level that has been established to be safe and effective. aiTBS will consist of bursts containing 3 pulses at 50 Hz. Bursts will be delivered at 5 Hz for 2 seconds at 80% of rMT, followed by 8 seconds without stimulation. This pattern will continue for 60 cycles (1800 pulses), for a total elapsed time of 10 minutes. Participants will be randomized to receive aiTBS to their mPFC, dlPFC, or primary somatosensory cortex (S1) a total of two times in a single session for 10 minutes each (spaced 50 minutes apart) before/after EEG preparation and practicing a positive affect technique (i.e., savoring), and before performing a positive savoring and reward responsivity task during EEG. | Device | Left Dorsolateral Prefrontal Cortex - Accelerated Intermittent Theta Burst, Left Primary Somatosensory Cortex - Accelerated Intermittent Theta Burst, Left Rostromedial Prefrontal Cortex - Accelerated Intermittent Theta Burst |
Primary outcome
Late Positive Potential during Positive Savoring
Time frame: From baseline EEG to post-stimulation EEG approximately 2 weeks apart
The late positive potential (LPP) is an established event-related potential that has been shown to be higher when savoring positive feelings elicited by positive images compared to neutral images. Changes in the LPP will be assessed from baseline EEG to post-stimulation EEG and compared between stimulation sites (left rostromedial PFC, left dorsolateral PFC, left primary somatosensory cortex).
1 secondary outcome
Positive Affect Ratings on the Positive and Negative Affect Schedule (PANAS)
Time frame: From the start to the end of a 3 hour study visit
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2026.
- Individual participant dataSharing planned: Yes. Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with FSU.
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.
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 Accelerated Intermittent Theta Burst Transcranial Magnetic Stimulation in people with Left Rostromedial Prefrontal Cortex - Accelerated Intermittent Theta Burst and Left Dorsolateral Prefrontal Cortex - Accelerated Intermittent Theta Burst, run by Florida State University 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 10 inclusion and 11 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: enrolling by invitation, as of the sponsor's last update on 20 May 2026. 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?
This study is still under way. Results are not available in the source record yet.
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?
Late Positive Potential during Positive Savoring (time frame: From baseline EEG to post-stimulation EEG approximately 2 weeks apart). 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 20 May 2026.