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Evaluating Gentle Electrical Stimulation Techniques for treatment of Tinnitus

Non-Invasive Neuromodulation for Tinnitus Management: Comparative Evaluation of Transcutaneous Auricular Vagal Nerve Stimulation and Transcranial Direct Current Stimulation Modalities - Nil

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/10/074596
Enrollment
90
Registered
2024-10-01
Start date
Unknown
Completion date
Unknown
Last updated
2024-10-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: H931- Tinnitus

Interventions

Intervention1: 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 intensity: 200% of the perception threshold for the participant receiving stimulation
frequency: 25 Hz
Pulse width:200 mcs
Intervention2: Group B. Intervention: Transcranial Direct Current Stimulation: Group B. Intervention: Transcranial Direct Current Stimulation Sessions: 10 sessions, 20 min duration each, 5 consecutiv
Anode: F4 Right dorsolateral prefrontal cortex
Stimulation intensity: 2mA
Control Intervention1: Group C : Comparator: Control Group: No neuromodulation: Group C : Comparator: Control Group: No neuromodulation

Sponsors

Nil
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

MeasureTime frame
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 levelsTimepoint: 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

MeasureTime frame
1. Performance in cognitive assessment tasks i.e., memory, executive and auditory processing. 2. Reduction in scores from pre-treatment levelsTimepoint: 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—

Countries

India

Contacts

Public ContactDr Garima Upreti

Department of Otorhinolaryngology, All India Institute of Medical Sciences-Rajkot

grmprt@gmail.com9871252109

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026