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rTMS Device for Improvement of Obsessive and Compulsive Behaviors

30 de junho de 2026 atualizado por: BTL Industries Ltd.

Evaluation of the Efficacy and Safety of an Accelerated Protocol for Obsessive and Compulsive Behaviour Using the BTL-699-2 Device

The goal of this investigational study is to evaluate if the treatment using EXOMIND(BTL-699-2) device is able to improve severity of obsessive and compulsive symptoms in adults (aged 22 and older).

The main question it aims to answer is:

Does the treatment using EXOMIND (BTL-699-2) device is able safely and efficiently reduce the severity of obsessive and compulsive behaviors?

Participants will be asked to:

  • Complete six treatment visits (twelve treatment sessions)
  • Complete The Yale-Brown Obsessive-Compulsive Severity Scale Second Edition Self Report Version (Y-BOCS-II SR)
  • Complete Short UPPS-P Impulsive Behaviour Scale (SUPPS-P)
  • Compete The Warwick-Edinburgh Mental Wellbeing Scale (WEMWBS)
  • Compete The Patient Health Questionnaire-9 (PHQ-9)
  • Compete Columbia Suicide Severity Rating Scale -screen version(CSSRS)
  • Complete Trigger Recall Experience Questionnaire (only for participants who agree to participate in trigger recall procedure during the treatment sessions)
  • Compete The Therapy Comfort Questionnaire
  • Compete The Subject Satisfaction Questionnaire

Visão geral do estudo

Status

Ainda não está recrutando

Condições

Intervenção / Tratamento

Descrição detalhada

This is a prospective, interventional, multi-centre, single-blinded, two-arm study. The subjects will be enrolled and randomly assigned to two experimental study arms: the active group (Group A) and the sham group (Group B), in a ratio of 3:1. All enrolled participants will be treated (either active or sham) with the BTL-699-2 device. Group A will receive active treatment (BTL-699-2 with intensity up to 80% of the individual's motor threshold (MT), and Group B will receive sham treatment (BTL-699-2 with intensity of 5% of the individual's MT).

The Yale-Brown Obsessive-Compulsive Severity Scale Second Edition Self Report Version (Y-BOCS-II SR), Short UPPS-P Impulsive Behavior Scale (SUPPS-P), The Warwick-Edinburgh Mental Wellbeing Scale (WEMWBS), Columbia Suicide Severity Rating Scale -screen version(CSSRS) and the urinary pregnancy test will be given to the subjects at baseline, at the last treatment visit, at the 1-month and at 3-month follow-up visits. The Patient Health Questionnaire-9 (PHQ-9) will be administered at baseline, after the second, fourth, and last treatment visits, at the 1-month and 3-month follow-up visits. The Trigger Recall Experience Questionnaire (TREQ) will be conducted at the end of each treatment session only for participants who voluntarily choose to engage in trigger recall procedure. Therapy Comfort questionnaires will be given to the subjects after the last treatment. Subject Satisfaction Questionnaire will be given to the subjects after the last treatment, and at both 1-month and 3-month follow-ups.

The approximate subject participation duration is six (6) months after the enrollment.

Tipo de estudo

Intervencional

Inscrição (Estimado)

60

Estágio

  • Não aplicável

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Locais de estudo

  • Estados Unidos
    • Arizona
      • Gilbert, Arizona, Estados Unidos, 85296
        • Contour Medical
        • Contato:
    • Florida
      • Winter Garden, Florida, Estados Unidos, 34787
        • Luxury Psychiatry Clinic
        • Contato:
    • Massachusetts
      • Wellesley, Massachusetts, Estados Unidos, 02481
        • Aesthetic + Mind
        • Contato:
          • Omotola T'Sarumi, MD
          • Número de telefone: 617-668-1239
          • E-mail: Info@drtola.com

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

  • Adulto
  • Adulto mais velho

Aceita Voluntários Saudáveis

Sim

Descrição

Inclusion Criteria:

  • Age 22 years and older
  • Voluntarily signed an informed consent form
  • Current presence of obsessive-compulsive behaviors of at least mild severity, defined as a Y-BOCS-II Self-Report total score ≥15.
  • Subjects willing and able to abstain from partaking in any treatments other than the pre-procedure therapy regime for the treatment of obsessive-compulsive behaviours, including non-invasive brain stimulation treatments other than the study procedure during study participation
  • 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.
  • If applicable, subjects will be maintained on pre-study psychotherapeutic regime, and neuropsychiatric prescribed medications (including SSRI or other medication, except for more than 2mg of lorazepam or equivalent) at a stable therapeutic dosage for at least 2 months prior to study entry
  • Women of child-bearing potential* are required to use birth control measures during the whole duration of the study
  • Willingness to comply with study instructions and to return to the clinic for the required visits *Women of childbearing potential are defined as any female who has experienced menarche and who is NOT permanently sterile or postmenopausal. Postmenopausal is defined as 12 consecutive months with no menses without an alternative medical cause.

Exclusion Criteria:

Device specific:

  • Metallic 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 12 in (30 cm) of the treatment coil
  • Implanted stimulator devices
  • rTMS devices are contraindicated for use in patients who have active or inactive implants (including device leads), including deep brain stimulators, cochlear implants, ocular implants and vagus nerve stimulators.
  • Contraindicated use could result in serious injury or death.
  • Drug pumps
  • Application in the heart area
  • Persons with a tendency to seizure (e.g., persons suffering from hypotonia and epilepsy)
  • Anticoagulation therapy
  • Severe or life-threatening condition
  • Pulmonary insufficiency
  • Heart disorders
  • Renal insufficiency
  • Decompensated hemorrhagic conditions
  • Decompensated blood coagulation disorders
  • Decompensated cardiovascular diseases
  • Malignant tumor or benign tumor
  • Fever
  • Pregnancy

Study specific:

  • Active suicidal intent
  • Prior treatment with TMS, rTMS, dTMS in the past 6 months or vagus nerve stimulator implant
  • Nursing
  • Neurological disorders, including a history of seizures, cerebrovascular disease, primary or secondary tumors in CNS, cerebral aneurysm, dementia, or movement disorders
  • History of increased intracranial pressure
  • Current head trauma
  • Any other disease or condition at the investigator's discretion that may pose risk to the patient or compromise the study

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Tratamento
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Solteiro

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: Active treatment with BTL-699-2
Participants will receive active treatment (BTL-699-2 intensity: up to 80% of MT)
Dispositivo: EXOMIND (BTL-699-2) Active treatment
Participants will receive twelve transcranial magnetic stimulation treatment sessions during 6 treatment visits (each treatment visit will include two treatment sessions) with the BTL-699-2 device over the left dorsomedial prefrontal cortex. The intensity will be adjusted according to the subject's feedback, up to 80% of the individual's motor threshold. The treatment visits will be spaced 2 - 4 days apart.
Comparador Falso: Sham treatment with BTL-699-2
Participants will receive sham treatment (BTL-699-2 intensity: 5% of MT)
Dispositivo: EXOMIND (BTL-699-2) Sham treatment
Participants will receive twelve transcranial magnetic stimulation treatment sessions during 6 treatment visits (each treatment visit will include two treatment sessions) with the BTL-699-2 device over the left dorsomedial prefrontal cortex. The intensity will be set to 5% of the individual's motor threshold. The treatment visits will be spaced 2 - 4 days apart.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
The Evaluation of the Change in Obsessive-Compulsive Behaviours in Adults
Prazo: 15 month
The change in the score obtained from the self-reported The Yale-Brown Obsessive-Compulsive Severity Scale Second Edition Self Report Version (Y-BOCS-II SR). The baseline score will be compared to the 3-month score. The 3-month score change will be compared between the active and sham groups. The total score ranges from 0 to 50, with higher scores indicating greater behavior severity. Improvement is considered a decrease in the obtained score.
15 month

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Evaluation of Change in Self- Reported Impulsivity in Adults
Prazo: 15 months
The change in the score obtained from the self-reported Short UPPS-P Impulsive Behavior Scale (SUPPS-P). The baseline score will be compared to the 3-months follow-up visit. The questionnaire includes 20 items relating aspects of impulsive personality and total score ranges from 20 to 80 with higher scores indicating higher levels of impulsivity. Improvement is considered a decrease in the obtained score.
15 months
Evaluation of Change in Self-Reported Well-Being in Adults
Prazo: 15 months
The change in the score obtained from the self-reported Warwick-Edinburgh Mental Well-being Scale (WEMWBS). The baseline score will be compared to the 1-month follow-up score. The total score ranges from 14 to 70, with higher scores indicating greater mental well-being and quality of life. Improvement is considered an increase in the obtained score.
15 months
Evaluation of Change in Self-Reported Depression Severity in Adults
Prazo: 15 months
The change in the score obtained from the self-reported Patient Health Questionnaire-9 (PHQ-9). The baseline score will be compared to the 3-month follow-up score. The total score from this 9-item questionnaire ranges from 0 to 27, with higher scores indicating greater depression severity. Improvement is considered a decrease in the obtained score.
15 months
Evaluation of Satisfaction
Prazo: 15 months
Subject Satisfaction with treatment outcomes will be assessed using 5-point Likert Scale Subjects Satisfaction 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.
15 months
Evaluation of Therapy Comfort
Prazo: 15 months
Therapy Comfort questionnaire consist of two questions and will be used for evaluating the comfort and pain during the treatment sessions. The Therapy Comfort questionnaire will be administered after the last treatment. The first question "I found the treatment comfortable", to which responses are based on a 5-point Likert scale (1 = "strongly disagree", and 5 = "strongly agree"). A higher score for the statement "I found the treatment comfortable" indicate higher therapy comfort. The second question includes a 10-point Numeric Analog Scale for pain (0 = no pain, 10 = worst possible pain). Lower scores on the Numeric Analog Scale indicate lower levels of pain.
15 months
Incidence of Treatment-related Adverse Events
Prazo: 15 months
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 obsessive and compulsive behaviors and to identify side effects and adverse events associated with the study treatment.
15 months
The subject-reported experience during trigger recall procedure
Prazo: 15 month
The Trigger Recall Experience Questionnaire (TREQ) is a self-administered questionnaire fill out at the end of each treatment session to evaluate subjective experiences of participants, who voluntarily engage in the trigger recall procedure. The questionnaire consists of 5 questions: one question (2nd question) utilizes a checklist with a list of specific thoughts and physical sensations, and the remaining four use Numerical Rating Scales (0 = none, 10 = maximum). It assesses three independent domains: 1) urge intensity(1st question), 2) emotional manageability(3rd and 4th question), and 3) sense of control(5th question). For urge intensity, a lower score indicates a lower strength of urges. For emotional manageability and sense of control, a higher score indicates greater manageability and control.
15 month

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

BTL Industries Ltd.

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Estimado)

24 de junho de 2026

Conclusão Primária (Estimado)

1 de dezembro de 2026

Conclusão do estudo (Estimado)

1 de dezembro de 2026

Datas de inscrição no estudo

Enviado pela primeira vez

24 de junho de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

30 de junho de 2026

Primeira postagem (Real)

1 de julho de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

1 de julho de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

30 de junho de 2026

Última verificação

1 de junho de 2026

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • BTL-699_CTUS1100

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

NÃO

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Sim

produto fabricado e exportado dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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