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CTRI Number  CTRI/2026/04/107884 [Registered on: 08/04/2026] Trial Registered Prospectively
Last Modified On: 08/04/2026
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Medical Device 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Use of new modality such as repetitive transmagnetic stimulation in addition to tinnitus retraining therapy in the management of patients complaining of ringing sensation in the ear  
Scientific Title of Study   Effect of rTMS(repetitive Transmagnetic Stimulation ) as an add on therapy to TRT (Tinnitus Retraining Therapy)in the management of chronic tinnitus 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Aakriti Chandra 
Designation  Assistant Professor 
Affiliation  AIIMS Guwahati 
Address  Room no 2075 second floor OPD Department of ENT AIIMS Guwahati

Kamrup
ASSAM
781101
India 
Phone  965086740  
Fax    
Email  aakritichandra91@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Aakriti Chandra 
Designation  Assistant Professor 
Affiliation  AIIMS Guwahati 
Address  AIIMS guwahati ,Department of ENT

Kamrup
ASSAM
781101
India 
Phone  965086740  
Fax    
Email  aakritichandra91@gmail.com  
 
Details of Contact Person
Public Query  
Name  Aakriti Chandra 
Designation  Assistant Professor 
Affiliation  AIIMS Guwahati 
Address  Room no 2075 second floor OPD Department of ENT AIIMS Guwahati

Kamrup
ASSAM
781101
India 
Phone  965086740  
Fax    
Email  aakritichandra91@gmail.com  
 
Source of Monetary or Material Support  
Nil 
 
Primary Sponsor  
Name  Aakriti Chandra  
Address  AIIMS Guwahati Department of ENT 781101 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Aakriti Chandra  AIIMS Guwahati   Room no 2075 Second floor OPD Department of ENT AIIMS guwahati Changasari Kamrup 781101
Kamrup
ASSAM 		 9650867440

aakritichandra91@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IEC AIIMS Guwahati  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: H931||Tinnitus,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  rTMS repetitive transmagentic stimulation  rTMS will be given to the patients of tinnitus . Site :left primary auditory cortex independent of handedness and tinnitus laterality. Equipment: Magstim Super Rapid 2 Figure of 8 coil. Protocol: 1Hz stimulus at 110% of the resting motor threshold for a total of 2000 pulses Frequency: once every 2 weeks till a total of 10 rTMS sessions for a period of 5 months. each session will last for 20 min for 10 such sessions for 5 months  
Comparator Agent  TRT tinnitus retraining therapy  • TRT is tinnitus retraining therapy which combines tinnitus specific educational counselling (TC) and low level broadband sound therapy (ST) to habituate the patient to perceived tinnitus so as to lessen the patent’s associated negative emotional reaction(annoyance , anxiety ) to improve their quality of life.the session will be taken at 2 weeks, 1 month ,3 month and 6 months 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  85.00 Year(s)
Gender  Both 
Details  All patients with subjective distressing tinnitus for 1 year ,Cochlear and retro-cochlear etiologies,Age more than 18 years,No other medical cause,Functionally adequate hearing so that sound therapy is audible,Score of 20 in tinnitus questionnaire(TQ) showing severe effect of tinnitus on quality of life.
 
 
ExclusionCriteria 
Details  Patients with pulsatile objective tinnitus as seen in Glomus tumours,Meningiomas,Adenomas,Vascular lesions,Conductive hearing loss
Patients with seizure disorder, substance disorders, head trauma or active brain infections/illnesses
Patients with implanted programmable devices (e.g. pacemaker) or other implanted metallic material in the brain
Pregnancy
Patients on seizure threshold lowering drugs like benzodiazepines, immunosuppressants, opioids, stimulants, prednisolone.
 
 
Method of Generating Random Sequence   Permuted block randomization, variable 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant, Investigator and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
• TFI ( Tinnitus Fuctional Index)
• THI( Tinnitus Handicap Index
 		 first visit, 3 months ,6 months and 9 months
 
 
Secondary Outcome  
Outcome  TimePoints 
• Improvement in quality of life of patient
• Clinicoepidemiological profile of patients with tinnitus.
 		 first visit,3 months ,6 months and 9 months 
 
Target Sample Size   Total Sample Size="140"
Sample Size from India="140" 
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   Phase 2 
Date of First Enrollment (India)   20/04/2026 
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="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. 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).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report

  3. 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.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [aakritichandra91@gmail.com].

  6. For how long will this data be available start date provided 30-06-2027 and end date provided 29-06-2030?
    Response - Beginning 9 months and ending 36 months following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - nil
Brief Summary   We are conducting a research on patients experiencing tinnitus for some time. We aim to look for newer treatment modaities for tinnitus in addition to standard of care. Our objective is to look for improvemnt on quality of life of patients after taking treatment such as tinnitus retraining therapy  and repetitive transmagnetic stimulation.The outcome will be assessed using validated questionaire such as TFI (tinnitus functional index)and THI (tinitus handicap inventory). The patients will be grouped into two groups ,one receiving TRT and the other receiving rTMS in addition to TRT.  
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