Ignite Creation Date:
2025-12-24 @ 3:58 PM
Ignite Modification Date:
2026-01-01 @ 11:00 PM
Study NCT ID:
NCT06910592
Status:
COMPLETED
Last Update Posted:
2025-09-17
First Post:
2025-03-28
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
EXOMIND (BTL-995) for Reduction of Binge-eating
Sponsor:
BTL Industries Ltd.
Organization:
Study Overview
Official Title:
Safety and Efficacy of the BTL-995-rTMS Device for the Reduction of Binge-eating
Status:
COMPLETED
Status Verified Date:
2025-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this clinical trial is to evaluate if the treatment with the BTL-995-rTMS device is able to reduce binge eating in adults above the age of 22 years. The main question it aims to answer is:
Whether the treatment with the BTL-995-rTMS device reduces binge eating.
Participants will be asked to:
Undergo six treatments Undergo weight measurements Complete the Binge Eating Scale Complete the Therapy Comfort Questionnaire Complete the Satisfaction Questionnaire
Whether the treatment with the BTL-995-rTMS device reduces binge eating.
Participants will be asked to:
Undergo six treatments Undergo weight measurements Complete the Binge Eating Scale Complete the Therapy Comfort Questionnaire Complete the Satisfaction Questionnaire
Detailed Description:
This study uses a single-center, single-arm, open-label, interventional design.
Subjects scoring more than 17 points on the Binge Eating Scale will be enrolled and assigned into one experimental study arm. All participants will receive six treatments with the BTL-995-rTMS device, administered 2 to 4 days apart.
Therapy parameters will be adjusted based on patient feedback and comfort, up to 70% of the individual's motor threshold.
Examination for possible adverse effects will be assessed at each visit.
The Binge Eating Scale will be administered before the first treatment, after the last treatment, and at the 1-month follow-up visit after the final session.
The Therapy Comfort Questionnaire will be administered after the last treatment, while the Satisfaction Questionnaire will be given after the last treatment and at the follow-up visit.
Subjects scoring more than 17 points on the Binge Eating Scale will be enrolled and assigned into one experimental study arm. All participants will receive six treatments with the BTL-995-rTMS device, administered 2 to 4 days apart.
Therapy parameters will be adjusted based on patient feedback and comfort, up to 70% of the individual's motor threshold.
Examination for possible adverse effects will be assessed at each visit.
The Binge Eating Scale will be administered before the first treatment, after the last treatment, and at the 1-month follow-up visit after the final session.
The Therapy Comfort Questionnaire will be administered after the last treatment, while the Satisfaction Questionnaire will be given after the last treatment and at the follow-up visit.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: