Binge-Eating DisorderNCT06910592
EXOMIND (BTL-995) for Reduction of Binge-eating
A study testing Treatment with BTL-995-rTMS in people with Binge-Eating Disorder, run by BTL Industries Ltd. at 1 site in Bulgaria.
Trial 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. Read more about this study
- Who is it for?
- Ages 22 years and olderHealthy volunteers can take part
- Conditions the study is for
- Binge-Eating Disorder
- What is being tested?
- Treatment with BTL-995-rTMS
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteBulgaria
- Study dates
- 26 Jul 2023to 11 Mar 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 22 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Scoring more than 17 points based on the BES
- Age > 22 years
- Voluntarily signed informed consent
- Ability to determine the motor threshold of the participant. The participant's motor threshold could be established as the minimum stimulus required to induce contraction of the right thumb
- Subjects willing and able to abstain from partaking in any other weight management treatments other than the study procedure during study participation
- Willingness to comply with study instructions and to return to the clinic for the required visits
- Women of child-bearing potential* are required to use birth control measures during the whole duration of the study
Who cannot join
- Electronic implants (Implanted stimulator devices in or near the head - rTMS devices are contraindicated for use in patients who have active or inactive implants (including device leads), deep brain stimulators, cochlear implants, ocular implant, and vagus nerve stimulators, implanted devices such as cardiac pacemakers, defibrillators, neurostimulators. Contraindicated use could result in serious injury or death.
- Metallic or other magnetic sensitive implants/objects in or near the head - rTMS devices are contraindicated for use in patients who have conductive, ferromagnetic or other magnetic-sensitive metals implanted in their head or within 30 cm of the treatment coil. (Examples include implanted electrodes/stimulators, aneurysm clips or coils, stents, bullet fragments, jewellery and hair barrettes. Failure to follow this restriction could result in serious injury or death.)
- Drug pump(s)
- Persons with a tendency to seizure (hypotonic, epileptic)
- Ongoing anticoagulation therapy
- Ongoing severe or life-threatening condition
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- Pulmonary insufficiency
- Heart disorders
- Renal insufficiency
- Decompensated hemorrhagic conditions, blood coagulation disorders, cardiovascular diseases
- Malignant or benign tumour
- Fever
- Facial tattoos with metallic ink (within 30 cm of the treatment coil)
- Pregnancy or nursing
- Ongoing intake disorders such as bulimia or anorexia, borderline personality disorder, major depression (elevated seizure risk) or bipolar disorder Personal history of epilepsy
- Personal history of syncope (except the reflex syncope)
- Vascular, traumatic, tumoral, infectious, or metabolic lesion of the brain, even without a history of seizure, and without anticonvulsant medication
- Withdrawal from one of the following drugs could form a relative hazard for the application of rTMS due to the resulting significant seizure threshold lowering potential: (e.g. alcohol, barbiturates, benzodiazepines, meprobamate, chloralhydrate etc.)
- Systemic infection
- Patients with a broad range of neuropsychiatric diseases are at elevated risk for seizures. Essentially all neurologic conditions with structural cerebral damage (e.g. stroke, multiple sclerosis, traumatic brain injury, Alzheimer's and other neurodegenerative diseases, meningoencephalitis or intracerebral abscess, parenchymal or leptomeningeal cancers) are associated with an elevated risk for seizures
- History of hyponatremia, hypocalcemia, hypomagnesemia, hypoglycemia, hyperglycemia, renal failure/uremia, liver failure
- History of tendency for raised blood concentrations of pro-convulsant medications due to reduced clearance (e.g. secondary to initiation of antibiotics for treatment of infections)
- Immunosuppressive therapy with cyclosporine, tacrolimus and other agents that can cause the posterior reversible leukoencephalopathy syndrome
- The use of amphetamines, barbiturates, cocaine metabolites, opiates and phencyclidine 72 hours before the therapy.
- Contradictions for the testing used in the trial, for example, the motor threshold cannot be found or quantified.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Safety and Efficacy of the BTL-995-rTMS Device for the Reduction of Binge-eating
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
Read the 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.
- Conditions
- Binge-Eating Disorder
- Being tested
- Treatment with BTL-995-rTMS
- Keywords
- binge-eating, overeating, weight loss, ExoTMS, EXOMIND
- Medical subject headings
- Binge-Eating Disorder, Bulimia Nervosa, Hyperphagia, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treatment with BTL-995-rTMSDevice
Also called EXOMIND (BTL-995) with ExoTMS
Six transcranial magnetic stimulation treatments with the BTL-995-rTMS device will be delivered over the left dorsolateral prefrontal cortex, spaced 2 to 4 days apart. The intensity will be adjusted according to the subject's feedback, up to 70% of the individual's motor threshold.
| Study group | Role | What they receive |
|---|---|---|
| Treatment with BTL-995-rTMS | Experimental | Transcranial magnetic stimulation treatment with the BTL-995-rTMS device Receives: Device: Treatment with BTL-995-rTMS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of Change in Binge Eating
The change in the score obtained from the Binge Eating Scale will be recorded. The questionnaire will be administered at the baseline visit, after the last treatment, and at the1-month follow-up visit. The score ranges from 0 to 46 and higher scores indicate more frequent and severe binge eating. An improvement is defined as a decrease in score.
Measured: 3 months
Secondary outcomes (3)
Assessment of Therapy Comfort
Therapy Comfort questionnaire will be used for evaluating the comfort during the treatment sessions. The Therapy Comfort questionnaire will be administered after the last treatment. Therapy Comfort questionnaire consists of the question "I found the treatment comfortable", to which responses are based on a 5-point Likert scale (1 = "strongly disagree", and 5 = "strongly agree") and the 10-point Numeric Analog Scale for pain (0 = no pain, 10 = worst possible pain"). A higher score for the statement "I found the treatment comfortable", and lower score on the Numeric Analog Scale for pain indicate higher therapy comfort.
Measured: 3 months
Assessment of Satisfaction
Subject Satisfaction with treatment outcomes will be assessed using 5-point Likert Scale Satisfaction questionnaire. The questionnaire will be administered after the last treatment, and at the 1-month follow-up visits. Responses to questions about binge eating and satisfaction with the treatment outcomes will range from "strongly agree" (5 points) to "strongly disagree" (1 point). A higher score for each statement indicate better outcomes.
Measured: 3 months
Incidence of Treatment-related Adverse Events
Monitoring of adverse reactions and side effects will be performed for the evaluation of safety of the treatment with the BTL-995-rTMS device for the reduction of binge eating and to identify side effects and adverse events associated with the study treatment.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2025
- Study start26 Jul 2023
- Primary completion15 Dec 2023
- Study completion11 Mar 2024
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.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- BTL Industries Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06910592
- Sponsor's protocol ID
- BTL-995_CTBG100
- Status last verified
- May 2025
- First submitted
- 28 Mar 2025
- Last updated
- 17 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of the BTL-995-rTMS Device for the Reduction of Binge-eating
- ClinicalTrials.gov ID
- NCT06910592
- Acronym / sponsor ID
- BTL-995_CTBG100
- Conditions
- Binge-Eating Disorder
- Keywords
- binge-eating, overeating, weight loss, ExoTMS, EXOMIND
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- BTL Industries Ltd.Industry (pharma, biotech, devices)
- Study start
- 26 Jul 2023 (actual)
- Primary completion
- 15 Dec 2023 (actual)
- Study completion
- 11 Mar 2024 (actual)
- First posted
- 4 Apr 2025 (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 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
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment with BTL-995-rTMS | Experimental | Device: Treatment with BTL-995-rTMSTranscranial magnetic stimulation treatment with the BTL-995-rTMS device |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Scoring more than 17 points based on the BES
- Age > 22 years
- Voluntarily signed informed consent
- Ability to determine the motor threshold of the participant. The participant's motor threshold could be established as the minimum stimulus required to induce contraction of the right thumb
- Subjects willing and able to abstain from partaking in any other weight management treatments other than the study procedure during study participation
Key exclusion criteria (25 listed)
- Electronic implants (Implanted stimulator devices in or near the head - rTMS devices are contraindicated for use in patients who have active or inactive implants (including device leads), deep brain stimulators, cochlear implants, ocular implant, and vagus nerve stimulators, implanted devices such as cardiac pacemakers, defibrillators, neurostimulators. Contraindicated use could result in serious injury or death.
- Metallic or other magnetic sensitive implants/objects in or near the head - rTMS devices are contraindicated for use in patients who have conductive, ferromagnetic or other magnetic-sensitive metals implanted in their head or within 30 cm of the treatment coil. (Examples include implanted electrodes/stimulators, aneurysm clips or coils, stents, bullet fragments, jewellery and hair barrettes. Failure to follow this restriction could result in serious injury or death.)
- Drug pump(s)
- Persons with a tendency to seizure (hypotonic, epileptic)
- Ongoing anticoagulation therapy
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 |
|---|---|---|
| Treatment with BTL-995-rTMSAlso: EXOMIND (BTL-995) with ExoTMSSix transcranial magnetic stimulation treatments with the BTL-995-rTMS device will be delivered over the left dorsolateral prefrontal cortex, spaced 2 to 4 days apart. The intensity will be adjusted according to the subject's feedback, up to 70% of the individual's motor threshold. | Device | Treatment with BTL-995-rTMS |
Primary outcome
Assessment of Change in Binge Eating
Time frame: 3 months
The change in the score obtained from the Binge Eating Scale will be recorded. The questionnaire will be administered at the baseline visit, after the last treatment, and at the1-month follow-up visit. The score ranges from 0 to 46 and higher scores indicate more frequent and severe binge eating. An improvement is defined as a decrease in score.
3 secondary outcomes
Assessment of Therapy Comfort
Time frame: 3 months
Assessment of Satisfaction
Time frame: 3 months
Incidence of Treatment-related Adverse Events
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2025.
- Individual participant dataSharing planned: No
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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.
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 Treatment with BTL-995-rTMS in people with Binge-Eating Disorder, run by BTL Industries Ltd. at 1 site in Bulgaria.
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 7 inclusion and 25 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: finished, as of the sponsor's last update on 17 Sep 2025. 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 Bulgaria. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Assessment of Change in Binge Eating (time frame: 3 months). 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 17 Sep 2025.