Your session is about to expire
← Back to Search
Transcranial Magnetic Stimulation
TMS for Anorexia
N/A
Recruiting
Led By Guido Frank, MD
Research Sponsored by University of California, San Diego
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Females ages 18 to 45 years
Current diagnosis of Anorexia Nervosa (AN) according to the DSM V, including having a severe fear of weight gain and body image distortion
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at study completion, up to 2 weeks
Awards & highlights
Study Summary
This trial is testing whether TMS, a new brain stimulation technique, can help treat anorexia nervosa, a severe psychiatric disorder associated with food avoidance and body image distortion.
Who is the study for?
This trial is for English-speaking females aged 18 to 45 with Anorexia Nervosa as per DSM V, either restricting or binge/purge subtype. Participants must not be pregnant, have metal implants near the head, major medical illnesses, substance abuse issues in the last month, certain psychiatric disorders, abnormal blood tests results or a history of seizures among other exclusions.Check my eligibility
What is being tested?
The study is testing Transcranial Magnetic Stimulation (TMS) using BrainsWay Model 104 system with H1-Coil to see if it can change brain activity and improve symptoms of Anorexia Nervosa. Some participants will receive real TMS while others get sham TMS without active treatment for comparison.See study design
What are the potential side effects?
Potential side effects from TMS may include discomfort at the stimulation site on the scalp, headache, lightheadedness, tingling sensations or muscle twitches during treatment sessions. There's also a small risk of seizure but this is rare.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am a woman aged between 18 and 45.
Select...
I have been diagnosed with Anorexia Nervosa and have a severe fear of gaining weight.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at study completion, up to 2 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at study completion, up to 2 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Acceptability of TMS procedures
Feasibility of TMS sessions
Secondary outcome measures
Beck Depression Inventory
Eating Disorders
Eating Disorders Inventory 3 Drive for Thinness Subscale
+3 moreTrial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Active iTBSExperimental Treatment1 Intervention
rTMS treatments will employ the Brainsway stimulator (Brainsway Ltd, Israel). Prior to the first treatment (no more than 5 days prior), each subject's motor threshold (MT) will first be determined according to published methods (Schutter, van Honk, 2006; Julkunen et al, 2009). This location, as well as the stimulation target spot, will be marked at the first session on the scalp and standard methods will be used to target this spot during treatment sessions. The modified BeamF3 scalp heuristic will be used to localize the treatment site over the left DLPFC (Mir-Moghtadaei et al., 2015). Subjects will complete 5 treatments days. A treatment day will consist of 10 treatment sessions with the start of each session timed to be at least 50 minutes from the previous session.
Group II: Sham iTBSPlacebo Group1 Intervention
The BrainsWay Model 104 with H4 coil has an integrated sham coil. The sham condition will start with the same clicking noise as the active TMS condition. Every helmet has a corresponding sham H-coil encased in the same helmet. The sham coil induces only a negligible sub-threshold field in the brain while making an identical noise and inducing some scalp sensation. Subjects will complete 5 treatments days. A treatment day will consist of 10 treatment sessions with the start of each session timed to be at least 50 minutes from the previous session. Subjects in this arm will have the option of receiving the Active iTBS protocol after they complete the 5 days of 10 daily treatment sessions.
Find a Location
Who is running the clinical trial?
University of California, San DiegoLead Sponsor
1,121 Previous Clinical Trials
1,521,385 Total Patients Enrolled
15 Trials studying Anorexia Nervosa
1,574 Patients Enrolled for Anorexia Nervosa
Guido Frank, MDPrincipal InvestigatorUniversity of California, San Diego
5 Previous Clinical Trials
435 Total Patients Enrolled
5 Trials studying Anorexia Nervosa
435 Patients Enrolled for Anorexia Nervosa
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am currently taking antidepressants or medication for seizures.I take more than 2 mg of lorazepam daily or I am on anticonvulsants.I am a woman aged between 18 and 45.I have a neurostimulator, intracardiac lines, or significant heart disease.I have a family history of epilepsy.I have had a stroke or other brain issues in the past.I have had a severe head injury with unconsciousness for over 5 minutes.I do not have a major illness, cardiac pacemaker, or medication pump.I have a history of conditions that could increase pressure inside my skull.I have a history of fainting due to heart-brain issues.I have been diagnosed with Anorexia Nervosa and have a severe fear of gaining weight.I have abnormal blood, kidney, or liver test results.
Research Study Groups:
This trial has the following groups:- Group 1: Active iTBS
- Group 2: Sham iTBS
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Does this scientific experiment involve any participants 45 years or older?
"Conforming to the guidelines of this clinical trial, the minimum age for enrollment is 18 and the maximum allowable age is 45."
Answered by AI
What is the enrollment capacity for this research endeavor?
"Affirmative. Clinicaltrials.gov offers evidence that this experiment was initially posted on June 16th 2022 and has recently been updated (July 19th 2022). At the moment, 40 volunteers need to be sourced from 1 medical facility."
Answered by AI
Is recruitment for this experiment underway?
"Affirmative, the clinical trial is still available for enrollment. The original advertisement was posted on June 16th 2022 and last modified on July 19th."
Answered by AI
What could be the potential outcomes of this clinical trial?
"The primary purpose of this two-week trial is to assess the feasibility of TMS sessions. Additionally, participants will be monitored for secondary objectives including changes in scores on the Spielberger State-Trait Anxiety Scale (STAI) measuring both state and trait anxiety, as well as body mass index which can provide information about food intake over time."
Answered by AI
Are there particular demographics that would be more suitable for this experiment?
"For this particular trial, 40 individuals between the ages of 18 and 45 suffering from anorexia nervosa have been recruited. In order to be eligible for inclusion, applicants must meet all of the following qualifications: female age range 18-45 years old; DSM V criteria including intense fear of gaining weight as well as distorted body image perception; restricting or binge/purge subtype behavior pattern; primary language spoken is English."
Answered by AI
Recent research and studies
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger