Health Condition 1: F90- Attention-deficit hyperactivity disorders
Conditions
Sponsors
BTL India Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean change reduction in ADHD RS 5 of at least 30 percent at the 1-month follow up compared to baseline Likert scoring.Timepoint: The estimated time required to complete the study and analyze data is 15 months. At the baseline visit, before the first study treatment, subjects will be examined to assess inclusion and exclusion criteria. Upon verification of the inclusion or exclusion criteria, the subjects will be required to complete six treatments (once or twice a week) and one follow up visit 1 month after the last treatment. The approximate subject participation duration is 3 months after the enrollment. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Proportion of subjects rated as very much improved or much improved by the Investigator using the Clinical Global Impression Improvement Subscale at the 1 month follow-up. 2.At least 80 percent of the treated subjects to report satisfaction level satisfied or very satisfied with the therapy outcome at 1 month follow-up using the Satisfaction Questionnaire. 3.Evaluation of the therapy comfort during the therapy with the BTL-699 device equipped with the BTL-699-AP-M-2 applicator via the Therapy comfort questionnaire.Timepoint: At the baseline visit, before the first study treatment subjects will be examined to assess inclusion and exclusion criteria. Upon verification of the inclusion or exclusion criteria, the subjects will be required to complete six treatments once or twice a week and one follow-up visit 1 month after the last treatment. The approximate subject participation duration is 3 months after the enrollment. | — |
Countries
India
Contacts
Public ContactDr Sowmyashree Narayan
Virgo Healthcare,bangalore
Outcome results
None listed