Binge-Eating DisorderNCT05806944
Transcranial Magnetic Stimulation for Binge Eating Disorder
A study of Binge-Eating Disorder, run by University of Southern California.
Trial summary
The primary goal of this study is to elucidate the impact of disorder provocation on the efficacy of TMS for the treatment of BED. In order to meet this objective, the investigators propose to evaluate this relationship in using a crossover study. Read more about this study
- Who is it for?
- Ages 18 to 30 years
- Conditions the study is for
- Binge-Eating Disorder
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- No sites listed yet
- Study dates
- 15 Dec 2023to 15 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- No healthy volunteers
- Adult
Who may be able to join
- English speaking (EPSI and Binge Eating Disorder Scale available only in English)
- Diagnosed with binge eating disorder as defined by the DSM-5 and in treatment for at least 6 months
- Stable doses of medications for at least 6 weeks
- Female subjects of childbearing age must consent to pregnancy tests at the beginning of each treatment session; will be counseled to use barrier methods during the course of this study
Who cannot join
- Contraindications to receiving TMS such as:
- Aneurysm clips or coils
- Stents in the neck or brain
- Deep brain stimulators
- Electrodes to monitor brain activity
- Metallic implants in ears and eyes
Show all 9Show fewer
- Shrapnel or bullet fragments in or near the head
- Facial tattoos with metallic or magnetic-sensitive ink
- Other metal devices or object implanted in or near the head
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Evaluation of Active Emotional State on the Efficacy of Transcranial Magnetic Stimulation
The primary goal of this study is to elucidate the impact of disorder provocation on the efficacy of TMS for the treatment of BED. In order to meet this objective, the investigators propose to evaluate this relationship in using a crossover study. Secondary objectives of this study include determining whether TMS with or without BED symptom provocation has effects in altering neurophysiology as detected by fMRI.
Read the detailed description
Current literature has demonstrated that transcranial magnetic stimulation (TMS) targeting the dorsolateral prefrontal cortex (DLPFC) has some efficacy in treating binge eating disorder. The investigators believe that TMS may be beneficial in the treatment of binge eating disorder. The purpose of this study is to determine whether TMS has efficacy for binge eating disorder and if symptom provocation affects treatment. This study will be conducted as a pilot study in the Keck Hospital clinics. 32 adult patients with a clinical diagnosis of binge eating disorder will be recruited.
- Conditions
- Binge-Eating Disorder
- Being tested
- TMS followed by Sham TMS, Sham TMS followed by TMS
- Keywords
- Transcranial Magnetic Stimulation
- Medical subject headings
- Binge-Eating Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TMS followed by Sham TMSDevice
double blinded crossover schedule in which participants will undergo TMS and assessment in one visit, followed by sham-TMS and assessment the next visit.
Sham TMS followed by TMSDevice
double blinded crossover schedule in which participants will undergo sham TMS and assessment in one visit, followed by TMS and assessment the next visit.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Patients with BED not undergoing symptom provocation Receives: Device: TMS followed by Sham TMS |
| Group B | Experimental | Patients with BED not undergoing symptom provocation Receives: Device: Sham TMS followed by TMS |
| Group C | Experimental | Patients with BED undergoing symptom provocation Receives: Device: TMS followed by Sham TMS |
| Group D | Experimental | Patients with BED undergoing symptom provocation Receives: Device: Sham TMS followed by TMS |
What is being measured
The primary outcome is the main question the study is designed to answer.
The effect of symptom provocation on TMS-mediated changes in the blood-oxygen-level-dependent(BOLD) signal
BOLD signals measure neural activity indirectly via neurovascular coupling
Changes in BOLD signals from baseline after TMS +/- symptom provocation will be compared after completion of the crossover study (day 33).
Measured: 33 Days
The effect of symptom provocation on TMS-mediated changes in the functional connectivity (FC) within and between pathophysiologically-relevant networks.
FC measures correlation in activity between different brain regions.
Changes in FC from baseline after TMS +/- symptom provocation will be compared after completion of the crossover study (day 33).
Measured: 33 Days
The effect of symptom provocation on TMS-mediated changes in the behavioral inhibition system (BIS)/behavioral activation system (BAS) scale score
BIS/BAS scale is a self reported 24 item questionnaire that assesses the BIS, a motivation system for avoiding aversive outcomes, and BAS, a motivation system for approaching goal-oriented outcomes. The total score for BIS scale ranges from 0 to 28 (7 items ranging from 0-4). The total score for BAS ranges from 0 to 52 (13 items ranging from 0-4). Four questions are fillers. Higher score represents greater severity of symptoms.
Changes in BIS/BAS scale from baseline after TMS+/- symptom provocation will be compared after completion of the crossover study (day 33).
Measured: 33 Days
The effect of symptom provocation on TMS-mediated changes in the Eating Disorder Examination - Questionnaire (EDE-Q)
The EDE-Q is a self report questionnaire of ED symptomatology over the preceding 28 days, that encompasses behavioral and attitudinal symptoms across four domains - dietary restraint, eating concern, shape concern, and weight concern. The subscores are calculated as follows:
Restraint = (Item 1 + Item 2 + Item 3 + Item 4 + Item 5) / 5; Eating Concern = (Item 6 + Item 7 + Item 9 + Item 15 + Item 34) / 5; Weight Concern = (Item 11 + Item 14 + Item 29 + Item 31 + Item 32) / 5; Shape Concern = (Item 10 + Item 11 + Item 12 + Item 13 + Item 30 + Item 33 + Item 35 + Item 36) / 8; Global Score = (Restraint + Eating Concern + Weight Concern + Shape Concern) / 4 Higher score represents greater severity of symptoms.
Changes in the EDE-Q score from baseline after TMS +/- symptom provocation will be compared after completion of the crossover study (day 33).
Measured: 33 days
The effect of symptom provocation on TMS-mediated changes in the Eating Disorder (ED 15) questionnaire.
The ED 15 questionnaire is a measure of eating disorder symptomatology, designed to measure dynamic, session-by-session fluctuations in ED symptom severity. The overall score ranges from 0-6, as it is calculated as the mean of the scores on all ten items, each ranging from 0-6 on symptom severity. Higher score represents greater severity of symptoms.
Changes in the ED 15 questionnaire score from baseline after TMS +/- symptom provocation will be compared after completion of the crossover study (day 33).
Measured: 33 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2023
- Study start15 Dec 2023 (estimated)
- Primary completion15 Dec 2024 (estimated)
- Study completion15 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Binge-Eating DisorderStudies of the same condition, open and under way.
- More trials run by University of Southern CaliforniaThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- double-blinded, pseudorandomized crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Southern California
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Darrin J Lee, MD, PhD, University of Southern California
- Investigators
- Darrin J Lee, MD PhD, Principal investigator, University of Southern California
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05806944
- Sponsor's protocol ID
- HS-21-00791
- Status last verified
- Dec 2023
- First submitted
- 15 Mar 2023
- Last updated
- 13 Dec 2023
- Results posted
- No
- 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 13 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Active Emotional State on the Efficacy of Transcranial Magnetic Stimulation
- ClinicalTrials.gov ID
- NCT05806944
- Acronym / sponsor ID
- HS-21-00791
- Conditions
- Binge-Eating Disorder
- Keywords
- Transcranial Magnetic Stimulation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- University of Southern CaliforniaUniversity, hospital or other
- Study start
- 15 Dec 2023 (estimated)
- Primary completion
- 15 Dec 2024 (estimated)
- Study completion
- 15 Dec 2024 (estimated)
- First posted
- 10 Apr 2023 (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.
The primary goal of this study is to elucidate the impact of disorder provocation on the efficacy of TMS for the treatment of BED. In order to meet this objective, the investigators propose to evaluate this relationship in using a crossover study. Secondary objectives of this study include determining whether TMS with or without BED symptom provocation has effects in altering neurophysiology as detected by fMRI.
Detailed description
Current literature has demonstrated that transcranial magnetic stimulation (TMS) targeting the dorsolateral prefrontal cortex (DLPFC) has some efficacy in treating binge eating disorder. The investigators believe that TMS may be beneficial in the treatment of binge eating disorder. The purpose of this study is to determine whether TMS has efficacy for binge eating disorder and if symptom provocation affects treatment. This study will be conducted as a pilot study in the Keck Hospital clinics. 32 adult patients with a clinical diagnosis of binge eating disorder will be recruited.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
- Model description
- double-blinded, pseudorandomized crossover
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Device: TMS followed by Sham TMSPatients with BED not undergoing symptom provocation |
| Group B | Experimental | Device: Sham TMS followed by TMSPatients with BED not undergoing symptom provocation |
| Group C | Experimental | Device: TMS followed by Sham TMSPatients with BED undergoing symptom provocation |
| Group D | Experimental | Device: Sham TMS followed by TMSPatients with BED undergoing symptom provocation |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- English speaking (EPSI and Binge Eating Disorder Scale available only in English)
- Diagnosed with binge eating disorder as defined by the DSM-5 and in treatment for at least 6 months
- Stable doses of medications for at least 6 weeks
- Female subjects of childbearing age must consent to pregnancy tests at the beginning of each treatment session; will be counseled to use barrier methods during the course of this study
Key exclusion criteria (9 listed)
- Aneurysm clips or coils
- Stents in the neck or brain
- Deep brain stimulators
- Electrodes to monitor brain activity
- Metallic implants in ears and eyes
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 |
|---|---|---|
| TMS followed by Sham TMSdouble blinded crossover schedule in which participants will undergo TMS and assessment in one visit, followed by sham-TMS and assessment the next visit. | Device | Group A, Group C |
| Sham TMS followed by TMSdouble blinded crossover schedule in which participants will undergo sham TMS and assessment in one visit, followed by TMS and assessment the next visit. | Device | Group B, Group D |
Primary outcome
The effect of symptom provocation on TMS-mediated changes in the blood-oxygen-level-dependent(BOLD) signal
Time frame: 33 Days
BOLD signals measure neural activity indirectly via neurovascular coupling Changes in BOLD signals from baseline after TMS +/- symptom provocation will be compared after completion of the crossover study (day 33).
The effect of symptom provocation on TMS-mediated changes in the functional connectivity (FC) within and between pathophysiologically-relevant networks.
Time frame: 33 Days
FC measures correlation in activity between different brain regions. Changes in FC from baseline after TMS +/- symptom provocation will be compared after completion of the crossover study (day 33).
The effect of symptom provocation on TMS-mediated changes in the behavioral inhibition system (BIS)/behavioral activation system (BAS) scale score
Time frame: 33 Days
BIS/BAS scale is a self reported 24 item questionnaire that assesses the BIS, a motivation system for avoiding aversive outcomes, and BAS, a motivation system for approaching goal-oriented outcomes. The total score for BIS scale ranges from 0 to 28 (7 items ranging from 0-4). The total score for BAS ranges from 0 to 52 (13 items ranging from 0-4). Four questions are fillers. Higher score represents greater severity of symptoms. Changes in BIS/BAS scale from baseline after TMS+/- symptom provocation will be compared after completion of the crossover study (day 33).
The effect of symptom provocation on TMS-mediated changes in the Eating Disorder Examination - Questionnaire (EDE-Q)
Time frame: 33 days
The EDE-Q is a self report questionnaire of ED symptomatology over the preceding 28 days, that encompasses behavioral and attitudinal symptoms across four domains - dietary restraint, eating concern, shape concern, and weight concern. The subscores are calculated as follows: Restraint = (Item 1 + Item 2 + Item 3 + Item 4 + Item 5) / 5; Eating Concern = (Item 6 + Item 7 + Item 9 + Item 15 + Item 34) / 5; Weight Concern = (Item 11 + Item 14 + Item 29 + Item 31 + Item 32) / 5; Shape Concern = (Item 10 + Item 11 + Item 12 + Item 13 + Item 30 + Item 33 + Item 35 + Item 36) / 8; Global Score = (Restraint + Eating Concern + Weight Concern + Shape Concern) / 4 Higher score represents greater severity of symptoms. Changes in the EDE-Q score from baseline after TMS +/- symptom provocation will be compared after completion of the crossover study (day 33).
The effect of symptom provocation on TMS-mediated changes in the Eating Disorder (ED 15) questionnaire.
Time frame: 33 days
The ED 15 questionnaire is a measure of eating disorder symptomatology, designed to measure dynamic, session-by-session fluctuations in ED symptom severity. The overall score ranges from 0-6, as it is calculated as the mean of the scores on all ten items, each ranging from 0-6 on symptom severity. Higher score represents greater severity of symptoms. Changes in the ED 15 questionnaire score from baseline after TMS +/- symptom provocation will be compared after completion of the crossover study (day 33).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2023.
- Individual participant dataSharing planned: No
Related trials for Binge-Eating Disorder
Not yet recruiting
Be Body Brave: Digital Written Exposure Therapy for Eating Disorders
Eating Disorders
Enrolling by invitation
Sleep and Activity For Eating Disorders
Eating Disorders, Anorexia Nervosa
Active, not recruiting
Project VIBE: Virtual Intervention for Binge Eating in Adolescents
Obesity, Binge-Eating Disorder
Not yet recruiting
Effectiveness of a 10-week Multicomponent Intervention Combined With Parent Education on Binge Eating Behavior in Children and Adolescents
Binge Eating Disorder, Binge Eating
Not yet recruiting
FUS Neuromodulation for Binge Eating Disorder
Binge-Eating Disorder
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.
Darrin J Lee, MD PhD principal investigator
University of Southern California
Questions about this trial
What is this clinical trial studying?
A study of Binge-Eating Disorder, run by University of Southern California.
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 4 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 13 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Darrin J Lee, MD PhD (9495220866, darrin.lee@med.usc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The effect of symptom provocation on TMS-mediated changes in the blood-oxygen-level-dependent(BOLD) signal (time frame: 33 Days). The study lists 5 primary outcomes in all. 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 13 Dec 2023.