| CTRI Number |
CTRI/2024/10/074596 [Registered on: 01/10/2024] Trial Registered Prospectively |
| Last Modified On: |
27/09/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
Evaluating Gentle Electrical Stimulation Techniques for treatment of Tinnitus |
|
Scientific Title of Study
|
Non-Invasive Neuromodulation for Tinnitus Management: Comparative Evaluation of Transcutaneous Auricular Vagal Nerve Stimulation and Transcranial Direct Current Stimulation Modalities |
| 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 Garima Upreti |
| Designation |
Assistant Professor, Otorhinolaryngology |
| Affiliation |
Department of Otorhinolaryngology, All India Institute of Medical Sciences, Rajkot |
| Address |
Department of Otorhinolaryngology, All India Institute of Medical Sciences-Rajkot, Khanderi, Para Pipaliya, Rajkot, Gujarat, INDIA, 360006
Rajkot
GUJARAT
360006
India |
| Phone |
9871252109 |
| Fax |
|
| Email |
grmprt@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Garima Upreti |
| Designation |
Assistant Professor, Otorhinolaryngology |
| Affiliation |
Department of Otorhinolaryngology, All India Institute of Medical Sciences-Rajkot |
| Address |
Department of Otorhinolaryngology, All India Institute of Medical Sciences-Rajkot, Khanderi, Para Pipaliya, Rajkot, Gujarat, INDIA, 360006
Rajkot
GUJARAT
360006
India |
| Phone |
9871252109 |
| Fax |
|
| Email |
grmprt@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Garima Upreti |
| Designation |
Assistant Professor, Otorhinolaryngology |
| Affiliation |
Department of Otorhinolaryngology, All India Institute of Medical Sciences-Rajkot |
| Address |
Department of Otorhinolaryngology, All India Institute of Medical Sciences-Rajkot, Khanderi, Para Pipaliya, Rajkot, Gujarat, INDIA, 360006
Rajkot
GUJARAT
360006
India |
| Phone |
9871252109 |
| Fax |
|
| Email |
grmprt@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences, Rajkot, Gujarat, India - 360006 |
|
|
Primary Sponsor
|
| Name |
Nil |
| Address |
Not Applicable |
| Type of Sponsor |
Other [Nil] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Garima Upreti |
AIIMS Rajkot |
Department of Otorhinolaryngology,
All India Institute Of Medical Sciences-Rajkot,
Khanderi, Para Pipaliya, Rajkot, Gujarat, INDIA
Rajkot
GUJARAT |
9871252109
grmprt@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, AIIMS Rajkot |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H931||Tinnitus, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Group A. Intervention: Transcutaneous Auricular Vagal Nerve Stimulation;
|
Group A. Intervention: Transcutaneous Auricular Vagal Nerve Stimulation
Sessions: 10 sessions, 30 min duration each, 2 days/ week for 5 weeks with an interval of minimum 48 hours between 2 sessions.
Stimulation protocol: Stimulation site: Left ear tragus, using bi electrode clip; Stimulation intensity: 200% of the perception threshold for the participant receiving stimulation; frequency: 25 Hz; Pulse width:200 mcs;
|
| Intervention |
Group B. Intervention: Transcranial Direct Current Stimulation |
Group B. Intervention: Transcranial Direct Current Stimulation
Sessions: 10 sessions, 20 min duration each, 5 consecutive days/ week for 2 weeks with an interval washout period of atleast 48-72 hours
Stimulation protocol:
Stimulation site: Cathode: F3 Left dorsolateral prefrontal cortex; Anode: F4 Right dorsolateral prefrontal cortex; Stimulation intensity: 2mA;
|
| Comparator Agent |
Group C : Comparator: Control Group: No neuromodulation |
Group C : Comparator: Control Group: No neuromodulation |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Tinnitus characteristics: Chronic (duration 3 months or more), subjective, non-pulsatile, primary, unilateral/bilateral, with or without SNHL
2. Normal otoscopic examination; No organic cause of tinnitus identified based on clinical assessment.
3. Willing to undergo the assigned treatment modality as per the study protocol.
4.Those not willing for neuromodulation, but meeting other criteria may be recruited as controls |
|
| ExclusionCriteria |
| Details |
1. Objective / pulsatile / synchronous tinnitus
2. Secondary tinnitus: External / middle ear pathology/ history of ear surgery/ trauma/ retro-cochlear neoplasm
3. Any associated neurological deficit except Sensori-neural hearing loss
4. History of neurosurgery, intracranial implant
5. Implanted cardiac pacemaker, cardioverter/defibrillator
6. Known cardiac condition; diagnosed neurological or clinical psychiatric disorder
7. Pregnancy
8. Previous treatment with taVNS, tDCS, TMS stimulation within the last six months. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Tinnitus severity: assessed using validated patient reported outcome measures (Tinnitus Handicap Inventory; Tinnitus Functional Index; VAS for tinnitus loudness, annoyance and distress; DASS; WHO quality of life index)
2. Reduction in scores from pre-treatment levels |
1. Baseline assessment (at the time of recruitment)
2. At completion of 10 sessions of neuromodulation for the intervention groups and 4-6 weeks post- recruitment for control group.
3. At 12 weeks (3 months) post baseline assessment |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Performance in cognitive assessment tasks i.e., memory, executive and auditory processing.
2. Reduction in scores from pre-treatment levels |
1. Baseline assessment (at the time of recruitment)
2. At completion of 10 sessions of neuromodulation for the intervention groups and 4-6 weeks post- recruitment for control group.
3. At 12 weeks (3 months) post baseline assessment |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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
|
N/A |
|
Date of First Enrollment (India)
|
10/10/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
10/10/2024 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Open to Recruitment |
| 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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [grmprt@gmail.com].
- For how long will this data be available start date provided 01-06-2027 and end date provided 31-05-2030?
Response - Beginning 9 months and ending 36 months following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
This interventional study aims to compare the efficacy of two non-invasive neuromodulation techniques i.e., transcutaneous auricular vagal nerve stimulation (taVNS) and transcranial direct current stimulation (tDCS) in managing chronic primary tinnitus. Participants will include adults with tinnitus (primary, subjective chronic ≥ 3 months duration) who will be allocated to either the taVNS or the tDCS group based on their treatment preference. Control group will include participants unwilling to receive neuromodulation but otherwise meeting the study criteria. Assessment of tinnitus severity and impact on participant’s quality of life will be done using validated patient reported outcome measures at baseline, immediately post-intervention, and 3 months follow-up from baseline. Additionally, the participants shall perform standardised cognitive tasks at each assessment, to assess potential impact on cognition. The change in tinnitus severity and cognitive performance will be compared in the three participant groups. We hypothesize that both neuromodulation modalities taVNS and tDCS significantly reduce tinnitus severity when compared to the control group (not receiving neuromodulation). |