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Well-Being, PsychologicalNCT06899646

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

A study testing Treatment with BTL-699-2 in people with Well-Being, Psychological, run by BTL Industries Ltd. at 3 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 22 years and olderHealthy volunteers can take part
Conditions the study is for
Well-Being, Psychological
What is being tested?
Treatment with BTL-699-2
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
38 participants
Where
3 sitesUnited States
Study dates
8 Jul 2024to 3 Feb 2025
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

  • 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

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, 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
Show all 26Show fewer
  • 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
  • Diagnosis of post-traumatic stress disorder, psychotic disorder or current psychotic symptoms, bipolar disorder, obsessive-compulsive disorder, borderline personality disorder
  • 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)
  • 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
  • Immunosuppressive therapy with cyclosporine, tacrolimus and other agents that can cause the posterior reversible leukoencephalopathy syndrome
  • The use of methamphetamine, 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

3 sites in 1 country.

United States3 sites

  • Contour Medical

    Gilbert, Arizona, 85296

  • Yael Halaas, M.D., F.A.C.S.

    New York, New York, 10022

  • Luxury Psychiatry Medical and Spa

    Winter Garden, Florida, 34787

Other trials in United States

About this study

Official title: Safety and Efficacy of BTL-699-2 for Improvement of Mental Well-being

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
Read the detailed description

The study uses a multi-center, single-arm, open-label, interventional study design. The subjects will be enrolled and assigned to one experimental study arm. All enrolled participants will receive four treatment visits, 5-10 days apart.

The Warwick Edinburgh Mental Well-being Scale (WEMWBS) will be administered to the subjects before the first treatment, after the last treatment, and at the two follow-up visits- 1 month and 3 months after the final session.

The Therapy Comfort Questionnaire will be administered after the last treatment, while the Subject Satisfaction \& Mental Wellness Questionnaire will be given after the last treatment and at both follow-up visits.

The total expected duration of subject participation, from the baseline visit to study completion, is approximately five months.

Being tested
Treatment with BTL-699-2
Keywords
well-being, TMS, rTMS, ExoTMS, EXOMIND
Medical subject headings
Psychological Well-Being

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Treatment with BTL-699-2Device

    Also called EXOMIND (BTL-699-2) Treatment

    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.

Study groups in NCT06899646
Study groupRoleWhat they receive
Treatment with BTL-699-2ExperimentalTranscranial magnetic stimulation treatments with the BTL-699-2 device
Receives: Device: Treatment with BTL-699-2

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 15 months

Secondary outcomes (3)

  1. 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: 15 months

  2. Assessment of Satisfaction

    Subject Satisfaction with treatment outcomes will be assessed using 5-point Likert Scale Subjects Satisfaction \& Mental Wellness questionnaire. The questionnaire will be administered after the last treatment, at the 1-month and 3-month follow-up visits. Responses to questions about satisfaction with the treatment outcomes will range from "strongly disagree" (1 point) to "strongly agree" (5 points). A higher score for each statement indicate better outcomes.

    Measured: 15 months

  3. 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-699-2 device for the improvement of well-being and to identify side effects and adverse events associated with the study treatment.

    Measured: 15 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Mar 2025
  2. Study start8 Jul 2024
  3. Primary completion3 Feb 2025
  4. Study completion3 Feb 2025

Resources

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
38 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06899646
Sponsor's protocol ID
BTL-699_CTUS100
Status last verified
Mar 2025
First submitted
26 Mar 2025
Last updated
21 Jul 2025
Results posted
No
FDA-regulated drug
No
FDA-regulated device
Yes

Questions about this trial

What is this clinical trial studying?

A study testing Treatment with BTL-699-2 in people with Well-Being, Psychological, run by BTL Industries Ltd. at 3 sites in United States.

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 6 inclusion and 26 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 21 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. 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 Mental Well-Being (time frame: 15 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06899646.

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 21 Jul 2025.

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