An interventional study of taVNS and Sham in Anorexia Nervosa, sponsored by Icahn School of Medicine at Mount Sinai. Recruiting at 1 site in United States. Open to participants aged 14 Years to 22 Years. Per ClinicalTrials.gov, last updated 2026-09-08.
Sponsored by Icahn School of Medicine at Mount Sinai · Not applicable, Interventional, and Treatment
Among 173 studies in Anorexia Nervosa with a site in United States — 36 open to participants now, 45 under way, none of them phase 3. Anorexia Nervosa · United States.
Among the 173 studies in Anorexia Nervosa with a site in United States, this one is the 83rd largest by planned enrollment of the 142 interventional ones, is one of 16 that started in 2022, is one of 93 with no phase, reaches primary completion later than 28 of the 44 other live ones, and was the 131st registered.
469 studies on the registry are indexed under Anorexia Nervosa; 127 are open to participants now.
This study's planned enrollment of 30 is below the median of 46 across 313 interventional studies indexed under Anorexia Nervosa.
Browse Anorexia Nervosa studies →36 of the 173 studies in Anorexia Nervosa with a site in United States are open now, in 6 countries. Each count lists the studies.
Of the 83 Anorexia Nervosa studies recruiting now, 18 (22%) set no upper age limit and 61 (73%) stop at 75 or younger; 48 take children under 18; 26 take healthy volunteers.
This study: 14 Years to 22 Years · all sexes · no healthy volunteers.
The full table on the hub →173 studies; the count open now beside each. This study's row is marked.
First in 2000; this study’s year is marked. 16 started in 2022.
Median enrollment 40 across the 142 interventional studies, 66 across the 31 observational. Of the 122 that completed or were terminated, 34 (28%) have results posted.
4 of 173 have an industry lead sponsor. The 10 most frequent:
Icahn School of Medicine at Mount Sinai is the lead sponsor of 776 studies on the registry; 176 are open to participants now.
Of its 125 completed or terminated interventional studies of FDA-regulated products, 83 (66%) have results posted.
Icahn School of Medicine at Mount Sinai has 5 studies filed under Anorexia Nervosa — fewer than ten, so there is no comparison to draw.
20 of the studies in Anorexia Nervosa with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06532734Denver Health and Hospital AuthorityBarrett's Esophagitis in Anorexia Nervosa Binge/Purge Subtype | 2026-11 |
| NCT05509257Children's Mercy Hospital Kansas CityNaltrexone Neuroimaging in Teens With Eating Disorders | 2026-12 |
| NCT04583774University of California, San DiegoDeveloping an EEG Paradigm to Study Prediction Error in Anorexia Nervosa | 2026-12 |
| NCT05197309Icahn School of Medicine at Mount SinaiMetabolic Diet for Relapse Prevention in Anorexia Nervosa | 2026-12 |
| NCT05170919Englewood Hospital and Medical CenterComparing Olanzapine and Mirtazapine in the Improvement of Unintentional Weight Loss for Patients with Advanced Stage Cancer | 2026-12 |
Among the 173 studies in Anorexia Nervosa with a site in United States, from their registry updates:
This project includes a 4-week randomized trial comparing pre-meal vagal nerve stimulation (taVNS) to pre-meal sham stimulation. The aims will assess if taVNS results in greater satisfaction, greater calorie consumption, less self-reported fullness, decrease in eating disorder symptoms, and less anxiety than sham stimulation.
The purpose of this research study is to determine the safety and ability of a device that will stimulate the vagus nerve (taVNS), in 30 adolescents ages 14-17. This project will explore if stimulation has any effect on eating behaviors in individuals with eating disorders, such as Anorexia Nervosa. Study measurements include eating behavior and other measures of behavior. These measurements will take place before and in response to the nerve stimulation during the course of a 4-week randomized trial.
Participants are assigned to one of two conditions: 1) Vagal Nerve Stimulation (n=20; this group includes use of the vagus nerve stimulator with stimulation); and 2) Sham Stimulation (n=10; this group includes use of the vagus nerve stimulator with no stimulation). Screening to determine eligibility includes physical measurements of height and weight, interview questions to determine inclusion/exclusion criteria and eating disorder diagnoses, and online REDCap surveys.
If eligible, participants will be scheduled for 5 study visits. Procedures will include taVNS, single item meals, check-ins during treatment in the Eating and Weight Disorders Program, and self-report questionnaires.
Clinic check-ins (3 days per week while in the clinic during the 4 week intervention) will include taVNS stimulation or sham for 30 minutes. Study Visits (4 weekly study visits lasting 1 hour each) will include a single item meal test, self-report surveys, and adverse event assessment and documentation. The follow-up visit, lasting 1 hour, will take place 1 week after the final study visit and includes self-report surveys and adverse event assessment and documentation.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
taVNS stimulation administered during intervention
Device: taVNS
Sham stimulation administered during intervention
Device: Sham
Participants will receive vagal nerve stimulation approximately 3 days a week for 30 minutes over the course of 4 weeks while they are attending treatment for Anorexia Nervosa in the Eating and Weight Disorder Intensive Program.
Participants will receive sham stimulation approximately 3 days a week for 30 minutes over the course of 4 weeks while they are attending treatment for Anorexia Nervosa in the Eating and Weight Disorder Intensive Program.
Satisfaction Rating Scale
Treatment satisfaction will be measured using a 10-point rating scale at the follow-up visit, with range from 0 to 10. A higher score will indicate higher level of satisfaction.
Time frame: 4 weeks
Percent of participants with treatment-related adverse events
Safety will be measured by documenting treatment-related adverse events during the 4 weeks of treatment. Occurrences will be reported according to % of participants experiencing a treatment-related adverse event.
Time frame: 4 weeks
Dropout Rate
Tolerability of treatment will be measured using dropout rates. The drop out rate will be reported according to % of participants dropping before the completion of the follow-up visit.
Time frame: 4 weeks
Total calories consumed
Autonomous eating will be measured in total calories consumed during 4 study visits. Total calories consumed will be calculated between study visit 1 and study visit 4.
Time frame: up to 4 weeks
Change in weight from baseline to 4 weeks
Weight will be measured in the EWDP IP clinic by study staff during all study visits. Change in weight will be calculated using the baseline and 4-week measurements.
Time frame: baseline and week 4
Change in the Clinical Impairment Assessment (CIA)
Impairment is measured using the Clinical Impairment Assessment, which is a 16-item self-report measure of impairment from eating disorders. Responses are scored using 0, 1, 2, or 3 and the score is calculated using the sum of all items. Possible scores range between 0 - 48, with higher scores indicating more impairment and lower scores indicating less impairment. Change in impairment will be calculated using the baseline and 4-week scores from CIA.
Time frame: baseline and week 4
Change in the Eating Disorder Examination (EDE-Q)
Change in eating disorder symptoms will be measured using the EDE-Q, which is a 28-item self-report measure assessing eating disorder symptoms. Each subscale (Restraint, Eating Concern, Shape Concern and Weight Concern) is scored 0-6. A global score (total scale from 0-6) is calculated by summing 4 subscales and then dividing by 4. A score of 4 or higher is considered clinically significant. Change in EDE-Q global score will be calculated using the baseline and 4-week scores.
Time frame: baseline and week 4
Change the Center for Epidemiological Studies Depression Scale (CESD)
Change in depression will be measured using the CESD, which is a 20-item self-report measure evaluating depressive symptoms. Total scores from 0 to 60. A higher score indicates higher levels of depressive symptoms. Change in CESD score will be calculated using the baseline and 4-week scores.
Time frame: baseline and week 4
Change the Anxiety Sensitivity Index (ASI)
Change in anxiety will be measured using the ASI, which is an 18-item self-report measure used to assess anxiety sensitivity. Total scores from 0-48. A higher score indicates more impairment. Change in ASI total score will be calculated using the baseline and 4-week scores.
Time frame: baseline and week 4
Change in the Visceral Sensitivity Index (VSI)
Changes in gastrointestinal-specific anxiety will be measured using the VSI, which is a 15-item measure. Total scores range from 0 (no GI-specific anxiety) to 75 (severe GI-specific anxiety). Higher scores indicate greater GI-specific anxiety. Change in VSI total score will be calculated using the baseline and 4-week scores.
Time frame: baseline and week 4
Change in hunger using a Visual Analogue Scale (VAS)
Change in hunger will be measured using a 15-cm visual analog scale. The total score ranges from 0-15, with higher ratings indicating greater hunger. Change in hunger will be calculated using the baseline and 4-week ratings.
Time frame: baseline and 4 weeks
Change in fullness using a Visual Analogue Scale (VAS)
Change in fullness will be measured using a 15-cm visual analog scale. The total score ranges from 0-15, with higher ratings indicating greater fullness. Change in fullness will be calculated using the baseline and 4-week ratings.
Time frame: baseline and 4 weeks
Change in sickness using a Visual Analogue Scale (VAS)
Change in sickness will be measured using a 15-cm visual analog scale. The total score ranges from 0-15, with higher ratings indicating greater sickness. Change in sickness will be calculated using the baseline and 4-week ratings.
Time frame: baseline and 4 weeks
Change in control using a Visual Analogue Scale (VAS)
Change in control will be measured using a 15-cm visual analog scale. The total score ranges from 0-15, with higher ratings indicating greater control. Change in control will be calculated using the baseline and 4-week ratings.
Time frame: baseline and 4 weeks
Change in urge to eat using a Visual Analogue Scale (VAS)
Change in urge to eat will be measured using a 15-cm visual analog scale. The total score ranges from 0-15, with higher ratings indicating a greater urge to eat. Change in urge to eat will be calculated using the baseline and 4-week ratings.
Time frame: baseline and 4 weeks
Change in thoughts of food using a Visual Analogue Scale (VAS)
Change in thoughts of food will be measured using a 15-cm visual analog scale. The total score ranges from 0-15, with higher ratings indicating greater thoughts of food. Change in thoughts of food will be calculated using the baseline and 4-week ratings.
Time frame: baseline and 4 weeks
Change in disgust using a Visual Analogue Scale (VAS)
Change in disgust will be measured using a 15-cm visual analog scale. The total score ranges from 0-15, with higher ratings indicating greater disgust. Change in disgust will be calculated using the baseline and 4-week ratings.
Time frame: baseline and 4 weeks
Change in fear using a Visual Analogue Scale (VAS)
Change in fear will be measured using a 15-cm visual analog scale. The total score ranges from 0-15, with higher ratings indicating greater fear. Change in fear will be calculated using the baseline and 4-week ratings.
Time frame: baseline and 4 weeks
Change in the Gastroparesis Cardinal Symptom Index (GCSI)
Change in gastroparesis will be measured using the GCSI, which is a 6-item measure. Full scale from 0-5. Higher scores indicate more discomfort. Change in GCSI total score will be calculated using the baseline and 4-week scores.
Time frame: baseline and 4 weeks
Change in the Disgust Scale-Revised (DS-R)
Change in disgust will be measured using the DS-R, which is a 27-item measure assessing degree of disgust associated with food. Scores range from 0 - 100 and higher scores indicate a higher level of disgust. Change in DS-R total score will be calculated using the baseline and 4-week scores.
Time frame: baseline and 4 weeks
Plan to share: No — Anonymized data can be made available upon request.
Started Dec 2022 (actual). Primary completion is estimated for Oct 2027, 58 months after the start.
Of 151 non-industry interventional studies with no phase under Anorexia Nervosa, half reached primary completion within 43 months of starting (the median), counting those still running; a quarter within 24 and three quarters within 63. This study's planned 58 months is above that.
Counting every sponsor, half of 151 studies reached it within 43 months; a quarter within 24 and three quarters within 63.
How these figures are worked out, and which studies are left out of them.
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Icahn School of Medicine at Mount Sinai →