HD-tDCS as a Treatment for Chronic Tinnitus

Not Applicable

Completed

• Conditions: Tinnitus, Subjective
• Interventions: Device: High Definition transcranial Direct Current Stimulation

• Registration Number: NCT04565132
• Lead Sponsor: University Hospital, Antwerp

Brief Summary

Transcranial Direct Current Stimulation (tDCS) aims to induce cortical plasticity by modulating the activity of brain structures. The broad stimulation pattern, which is one of the main limitations of tDCS, can be overcome with the recently developed technique called High-Definition tDCS (HD-TDCS). The objective of the current study is to investigate the effect of HD-tDCS on tinnitus in a large patient cohort.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-10-21
• Primary Completion: 2019-04-08
• Study Completion: 2019-04-09
• Status Verified: 2020-08
• Study First Submitted: 2020-08-12
• Study First Submitted QC: 2020-09-24
• Last Update Submitted: 2020-09-24
• Study First Posted: 2020-09-25
• Last Update Posted: 2020-09-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 117

Inclusion Criteria

• chronic, subjective, non-pulsatile tinnitus
• met the criteria for HD-tDCS safety

Exclusion Criteria

• a middle ear pathology
• another tinnitus treatment ongoing

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
HD-tDCS	High Definition transcranial Direct Current Stimulation	Each patient received a total of six sessions of anodal HD-tDCS of right DLPFC.

Primary Outcome Measures

Name	Time	Method
Change in Tinnitus Functional Index (TFI)	Baseline (before intervention), immediately post intervention, 7 weeks follow-up	Tinnitus severity self-report questionnaire, ranging from 0-100 with a higher score representing a more severe tinnitus

Secondary Outcome Measures

Name	Time	Method
Change in Visual Analogue scale (VAS) for tinnitus loudness	Baseline (before intervention), immediately post intervention, 7 weeks follow-up	Visual analogue scale measuring tinnitus loudness from 0-100, with a higher score representing a louder tinnitus Visual analogue scale measuring tinnitus loudness from 0-100, with a higher score representing a louder tinnitus
Change in Tinnitus Questionnaire (TQ)	Baseline (before intervention), immediately post intervention, 7 weeks follow-up	Tinnitus severity self-report questionnaire, ranging from 0-84 with a higher score representing a more distressing tinnitus
Change in Hospital Anxiety and Depression Scale (HADS)	Baseline (before intervention), immediately post intervention, 7 weeks follow-up	Self-report questionnaire concerning anxiety and depression symptoms, ranging from 0-21 for each subscale. A result greater than 8 suggests the presence of a depression and/or anxiety disorder. Visual analogue scale measuring tinnitus loudness from 0-100, with a higher score representing a louder tinnitus
Change in Hyperacusis Questionnaire (HQ)	Baseline (before intervention), immediately post intervention, 7 weeks follow-up	Hyperacusis severity self-report questionnaire, ranging from 0-42 with a higher score representing a higher sensitivity to sounds. A score of 28 is the cut-off for auditory hypersensitivity.