Safety and Efficacy of Non-Invasive Treatment of ADHD
试验速览
- 阶段
- Unknown
- 状态
- 尚未招募
- 发起方
- 入组人数
- 31
- 试验地点
- 1
研究概览
简要总结
Purpose of the clinical investigation: The purpose of this study is to evaluate safety and effectiveness of the BTL-699 device equipped with BTL-699-AP-M-2 applicator for non-invasive treatment of ADHD.
Intended users:
The device shall be operated by a physician trained in application of transcranial magnetic stimulation or by a healthcare professional under supervision of a physician defined above. The user shall be familiar with all safety precautions and warnings, operating procedures and maintenance instructions given in the User’s manual.
Intended population and indications for use:
The device is intended for adolescents aged 15 years and older only excluding pregnant or breastfeeding women. The patient must not show any signs of contraindications. Before applying the therapy, it is necessary to consider the patient’s medical history and examine the patient thoroughly to determine whether or not the application of therapy is suitable for the patient. A special population where the safety and effectiveness of the therapy has not been established is defined in the chapter Special population of the User’s manual.
Type of Clinical Investigation:
Prospective, open-label, one-arm, single-center, interventional study.
The study design does not include any comparator or control/sham group. The absence of comparator in the study is justified by the manner of treatment administration which is accompanied by characteristic signs such as pressure in the treated area or tickling which restrains the utilization of suitable sham protocol. Furthermore, a comparator was not deemed to be required to address study hypotheses as per the study design, and the recognized performance goal of clinical significance was chosen for hypothesis testing. Thus the feasibility and ethical acceptability of comparators is not well-founded.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 15.00 Year(s) 至 19.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Adolescents aged 15 to 19 years seeking treatment of ADHD symptoms 2.Subject to be diagnosed with ADHD as per DSM 5 TR 3.Stably on or off psychoactive medications for greater or equal 4 weeks prior to study enrollment and during the course of the study 4.Subjects and their legally designated representatives should be able to understand the investigative nature of the treatment, the possible benefits and side effects, and must sign the Informed Consent Form 5.Subjects and their legally designated representatives willing and able to comply with protocol requirements, including obtaining study-required assessments and returning for follow up visit 6.Subjects willing and able to abstain from partaking in any new treatments other than the study procedure to treat ADHD during study participation.
排除标准
- •1.Electronic implants i.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 implants ii.and vagus nerve stimulators, implanted devices such as cardiac pacemakers, defibrillators, and neurostimulators or other electronic implants in or near the head 2.Metallic, ferromagnetic or other magnetic-sensitive implants/objects in or near the head i.rTMS devices are contraindicated for use in patients who have conductive, ferromagnetic or other magnetic-sensitive metals implanted in their head (with some exceptions in the mouth.
- •see the Safety Precautions and Warnings) or within 30 cm (12 in) of the treatment coil (examples include implanted electrodes/stimulators, aneurysm clips or coils, stents, bullet fragments, jewellery, and hair barrettes) 3.Application in the heart area 4.Persons with a tendency to seizures (e.g., persons suffering from hypotonia and epilepsy) 5.Anticoagulation therapy 6.Severe or life-threatening condition 7.Renal dialysis therapy or decompensated renal insufficiency 8.Decompensated hemorrhagic conditions 9.Decompensated blood coagulation disorders 10.Decompensated cardiovascular diseases 11.Malignant tumour or benign tumour (within 30 cm of the treatment coil) 12.Fever 13.Application over or in the near proximity (within 30 cm of the treatment coil) of tattoos with metallic ink.
研究者
Dr Sowmyashree Narayan
Virgo Healthcare,bangalore