EXOMIND (BTL-699-2) for Improvement of Mental Well-being

NCT06899646 | Completed FDA Device

• 1 other identifier: BTL-699_CTUS100
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 3

Brief Summary

The goal of this clinical trial is to evaluate if the treatment with EXOMIND (BTL-699-2) device is able to improve mental well-being in adults above the age of 22 years. The main question it aims to answer is: Does the treatment with EXOMIND (BTL-699-2) device improve mental well-being? Participants will be asked to:

• Undergo four treatments
• Complete the Warwick Edinburgh Mental Well-being Scale
• Complete the Therapy Comfort Questionnaire
• Complete the Subject Satisfaction \& Mental Wellness Questionnaire

Conditions

Well-Being, Psychological

Keywords

well-being; TMS; rTMS; ExoTMS; EXOMIND

Outcome Measures

Primary Outcomes (1)

• Assessment of Change in Mental Well-Being

  The change in the score obtained from the Warwick Edinburgh Mental Well-being Scale will be recorded. The questionnaire will be administered at the baseline visit, after the last treatment, at the 1-month and 3-month follow-up visits. The score ranges from 14 to 70 and higher scores indicate greater mental well-being. An improvement is defined as an increase in score.

  15 months

Secondary Outcomes (3)

• Assessment of Therapy Comfort

  15 months

• Assessment of Satisfaction

  15 months

• Incidence of Treatment-related Adverse Events

  15 months

Study Arms (1)

Treatment with BTL-699-2

EXPERIMENTAL

Transcranial magnetic stimulation treatments with the BTL-699-2 device

Device: Treatment with BTL-699-2

Interventions

Treatment with BTL-699-2 DEVICE

Four transcranial magnetic stimulation treatments with the BTL-699-2 device will be delivered over the left dorsolateral prefrontal cortex, spaced 5 to 10 days apart. The intensity will be adjusted according to the subject's feedback, up to 100% of the individual's motor threshold.

Also known as: EXOMIND (BTL-699-2) Treatment

Treatment with BTL-699-2

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \> 22 years
• 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 treatments other than the pre-procedure therapy regime for the improvement of mental well-being, including non-invasive brain stimulation 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
• If applicable, subjects will be maintained on pre-study psychotherapeutic regime, and neuropsychiatric prescribed medications (including SSRI or other medication) at a stable therapeutic dosage for at least 2 months prior to study entry

You may not qualify if:

• 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, conductive, ferromagnetic or other magnetic sensitive implants/objects in the head or within 30 cm of the treatment coil (examples include implanted electrodes/stimulators, aneurysm clips or coils, stents, bullet fragments, jewelry and hair barrettes) with some exceptions in the mouth as standard amalgam dental fillings, single post dental implants, and dental bridge work. Failure to follow this restriction could result in serious injury or death.
• Drug pump(s)
• Application in the heart area
• Persons with a tendency to seizure (hypotonic, epileptic), or a personal history of epilepsy
• Ongoing anticoagulation therapy
• Ongoing severe or life-threatening condition
• Pulmonary insufficiency
• Heart disorders
• Renal insufficiency
• Decompensated\* hemorrhagic conditions, blood coagulation disorders, cardiovascular diseases
• Malignant or benign tumor
• Fever
• Ongoing pregnancy or nursing
• Ongoing intake disorders such as bulimia or anorexia

Sponsors & Collaborators

• BTL Industries Ltd.: lead

Study Sites (3)

Contour Medical

Gilbert, Arizona, 85296, United States

Location

Luxury Psychiatry Medical and Spa

Winter Garden, Florida, 34787, United States

Location

Yael Halaas, M.D., F.A.C.S.

New York, New York, 10022, United States

Location

MeSH Terms

Conditions

Psychological Well-Being

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Personal Satisfaction; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 26, 2025
• First Posted: March 28, 2025
• Study Start: July 8, 2024
• Primary Completion: February 3, 2025
• Study Completion: February 3, 2025
• Last Updated: July 21, 2025

Record last verified: 2025-03

Locations

US (3)