| CTRI Number |
CTRI/2024/02/063177 [Registered on: 27/02/2024] Trial Registered Prospectively |
| Last Modified On: |
25/02/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Effect of Transcutaneous Electrical Nerve Stimulation in ringing sensation of the ear |
|
Scientific Title of Study
|
Effect of Transcutaneous Electrical Nerve Stimulation in Tinnitus - An Academic Study |
| Trial Acronym |
Tinnitens |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Aishwari Iyer |
| Designation |
Junior Resident |
| Affiliation |
AIIMS Mangalagiri |
| Address |
room no 311 department of ENT
OPD block AIIMS Mangalagiri guntur 522503
Guntur
ANDHRA PRADESH
522503
India |
| Phone |
7021191409 |
| Fax |
|
| Email |
aishwariiyer.swastik3@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Satvinder Singh Bakshi |
| Designation |
Additional Professor |
| Affiliation |
AIIMS Mangalagiri |
| Address |
Room no 311 Department of ENT OPD block AIIMS Mangalagiri guntur 522503
Guntur
ANDHRA PRADESH
522503
India |
| Phone |
9698420998 |
| Fax |
|
| Email |
bakshi.s@aiimsmangalagiri.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Aishwari Iyer |
| Designation |
Junior Resident |
| Affiliation |
AIIMS Mangalagiri |
| Address |
Room no 311 Department of ENT OPD block AIIMS Mangalagiri guntur 522503
Guntur
ANDHRA PRADESH
522503
India |
| Phone |
7021191409 |
| Fax |
|
| Email |
aishwariiyer.swastik3@gmail.com |
|
|
Source of Monetary or Material Support
|
| Self Funding Dr Aishwari Iyer
Junior Resident Room no 311 Department of ENT OPD block AIIMS mangalagiri guntur district Andhra pradesh 522503 |
|
|
Primary Sponsor
|
| Name |
Dr Aishwari Iyer |
| Address |
Room no 311 Department of ENT OPD block AIIMS mangalagiri guntur district Andhra pradesh 522503 |
| Type of Sponsor |
Government medical college |
|
|
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 Aishwari Iyer |
AIIMS Mangalagiri |
ENT OPD ( 311 ) AIIMS Mangalagiri, guntur , andhra pradesh - 522503
Guntur
ANDHRA PRADESH |
7021191409
aishwariiyer.swastik3@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| AIIMS Mangalagiri Ethics committee |
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 |
| Comparator Agent |
Standard care of treatment |
Standard care of treatment |
| Intervention |
Transcutaneous electrical nerve stimulation |
Auricles would be cleaned with alcohol, and probes would be placed at 5 of 13 possible points where electrical resistance is low and conductance of the electrical current is high relative to the surrounding area.
Current intensity would be about 15 mA.
The device has on and off, pulse square, frequency, and current intensity buttons. An alternating, pulsed current at low frequency 50 Hz will be used for tinnitus suppression. Hand-held electrodes would be placed on the external pinna and stimulation duration would be 30 seconds for each point. In total, therapy sessions for each patient would be instituted twice a week for a total of 4 weeks, that is 8 sessions .
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patients with perceived tinnitus for a minimum duration of 3 months and Willing to give written consent and take part in the study |
|
| ExclusionCriteria |
| Details |
1.) Patient refusal
2.) Patients who have any internal electrical device (example: cardiac pacemakers and metal plates) 3.) Patients having pre-existing cardiac disorders .
4.) Cases of objective tinnitus ( eg . glomus tumour , palatal myoclonus ) 5.) If they had received TENS, acupuncture, or electroacupuncture for any other condition
6.) Pregnancy
|
|
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Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To study reduction in subjective sensation in tinnitus using Tinnitus Handicap Inventory , Visual Analogue Scale |
To study reduction in subjective sensation in tinnitus using Tinnitus Handicap Inventory , Visual Analogue Scale at end of each session that will be undertaken twice a week for 4 weeks and thereafter at 1 month , 3 months and 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To estimate the severity of tinnitus as assessed by Tinnitus handicap index. To study the duration of effect of TENS , on tinnitus. To determine the effect of transcutaneous electrical nerve stimulation on various domains of THI .
|
To estimate the severity of tinnitus, duration of reduction in subjective sensation of tinnitus if any ,to determine the effect of transcutaneous electrical nerve stimulation on various domains of THI using Tinnitus Handicap Inventory , Visual Analogue Scale at end of each session that will be undertaken twice a week for 4 weeks and thereafter at 1 month , 3 months and 6 months |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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 3 |
|
Date of First Enrollment (India)
|
21/03/2024 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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 - NO
|
|
Brief Summary
|
Tinnitus is the perception of a sound in the absence of external sound stimulation. Subjective tinnitus is defined as the perception of a sound in the absence of any external vibratory stimulation The reactions to tinnitus have been classified into four primary functions of daily living activities: emotions, hearing, sleep and concentrations . Tinnitus may result in anxiety, depression, insomnia, and poor quality of life in patients. Noting the mechanisms producing tinnitus , neuromodulation is being attempted to hamper the neural pathways producing tinnitus . The mechanism involves activation of the nucleus of the solitary tract, which in turn activates the locus coeruleus and nucleus basalis, which then releases neuromodulators that have effects on plasticity regulation by modulating the neurons in the cortex . As tinnitus is associated with an imbalance between excitation and inhibition that may lead to map reorganization and increased synchronous firing of auditory neurons , neuromodulation by vagal nerve stimulation might have a positive influence on this process. In this study we aim to study the effect of transcutaneous electrical nerve stimulation in reducing the subjective tinnitus. Population of study is those patients with subjective tinnitus meeting our inclusion criteria. It will take place in the ENT OPD of our hospital It is a triple blinded randomized control trial. Patients between 18 to 65 years suffering from perception of tinnitus for a minimum period of 3 months would be included in our study .History taking and physical examination will be done followed by relevant investigations . Patients with objective tinnitus will be excluded from the study Patients consent will be taken. Patients with tinnitus will be randomly allocated to the verum TENS group and sham TENS group in a 1:1 ratio. Patients would complete questionnaires including the visual analog scale (VAS) , Tinnitus Handicap Inventory (THI). Total of 30 patients in the treatment arm ( electrical stimulation / verum arm ) would be subjected to TENS twice a week for a period of 4 weeks . For the sham stimulation group - 30 , the treatment paradigm would be identical to the electrical stimulation group except that the power supply would be turned off and current would not be delivered from the probe. Even in the electrical stimulation group, patients would not be able to feel sound vibrations or sense current delivery. Patients would thus be unaware of the treatment group to which they are assigned. THI and VAS that were administered to the patients at the beginning of the study would be given again and responses would be noted after every session , one monthly , 3 monthly and 6 monthly intervals either in person or in a telephonic format . Thus patients would be followed up over a period of 6 months .
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