| CTRI Number |
CTRI/2026/01/101979 [Registered on: 23/01/2026] Trial Registered Prospectively |
| Last Modified On: |
20/08/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Non-Invasive Treatment of ADHD |
|
Scientific Title of Study
|
Safety and Efficacy of Non-Invasive Treatment of ADHD |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sowmyashree Narayan |
| Designation |
Adolescent and Child Psychiatrist |
| Affiliation |
Virgo Healthcare,bangalore |
| Address |
Virgo Healthcare
Address: 8th floor, unit no. 809, tower-B Brigade signature towers, Kattamanallur gate fly over, Bangalore
Bangalore
KARNATAKA
560049
India |
| Phone |
9108801971 |
| Fax |
|
| Email |
drsowmyashreepsychiatrist@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sowmyashree Narayan |
| Designation |
Adolescent and Child Psychiatrist |
| Affiliation |
Virgo Healthcare,bangalore |
| Address |
Virgo Healthcare
Address: 8th floor, unit no. 809, tower-B Brigade signature towers, Kattamanallur gate fly over, Bangalore
Bangalore
KARNATAKA
560049
India |
| Phone |
9108801971 |
| Fax |
|
| Email |
drsowmyashreepsychiatrist@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sowmyashree Narayan |
| Designation |
Adolescent and Child Psychiatrist |
| Affiliation |
Virgo Healthcare,bangalore |
| Address |
Virgo Healthcare
Address: 8th floor, unit no. 809, tower-B Brigade signature towers, Kattamanallur gate fly over, Bangalore
Bangalore
KARNATAKA
560049
India |
| Phone |
9108801971 |
| Fax |
|
| Email |
drsowmyashreepsychiatrist@gmail.com |
|
|
Source of Monetary or Material Support
|
| BTL India Pvt Ltd
Address: 7th Floor, Tower 1, Umiya Business Bay,
Embassy Tech Square Main Rd, Kaverappa Layout,Kadubeesanahalli, Kadubeesanahalli, Bengaluru, Karnataka 560103 |
|
|
Primary Sponsor
|
| Name |
BTL India Pvt Ltd |
| Address |
7th Floor, Tower 1, Umiya Business Bay, Embassy Tech Square Main Rd, Kaverappa Layout,Kadubeesanahalli, Kadubeesanahalli, Bengaluru, Karnataka 560103 |
| Type of Sponsor |
Other [Medical device manufacturer] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr K Ramakrishnan |
Athma Mind Care Hospital |
12 B&C, 10th Cross east, Rahumaniya Puram, Thillai Nagar, Tennur, Tiruchirappalli, Tamil Nadu
Tiruchirappalli
TAMIL NADU |
919894722221
drkrk@athmahospitals.com |
| Dr Sowmyashree Narayan |
Virgo Healthcare |
8th floor, unit no. 809, tower-B Brigade signature towers, Kattamanallur gate fly over, Bangalore, Karnataka-560049
Bangalore
KARNATAKA |
09108801971
drsowmyashreepsychiatrist@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| ACE Independent Ethics Committee |
Approved |
| Institutional Ethics Committee Athma Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F90||Attention-deficit hyperactivity disorders, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
BTL-699
Doc Type and Number Document Name Version Effective Date Page
FO-775 Clinical Investigation Plan EN-101 October 10, 2024 16/65
Accessories: BTL-699-AP-M-2 |
The device is intended for treatment of Attention-Deficit Hyperactivity Disorder (ADHD). |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
19.00 Year(s) |
| Gender |
Both |
| Details |
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 |
|
| ExclusionCriteria |
| Details |
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. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Mean change reduction in ADHD RS 5 of at least 30 percent at the 1-month follow up compared to baseline Likert scoring. |
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 Outcome
|
| Outcome |
TimePoints |
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. |
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. |
|
|
Target Sample Size
|
Total Sample Size="31"
Sample Size from India="31"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
28/05/2026 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
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. |