HD-tDCS as a Treatment for Chronic Tinnitus

High Definition Transcranial Direct Current Stimulation (HD-tDCS) for Chronic Tinnitus: Outcomes From a Prospective Longitudinal Large Cohort Study

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.

Study Overview

• Status: Completed
• Conditions: Tinnitus, Subjective
• Intervention / Treatment: Device: High Definition transcranial Direct Current Stimulation

• Study Type: Interventional
• Enrollment (Actual): 117
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: HD-tDCS; Each patient received a total of six sessions of anodal HD-tDCS of right DLPFC.	Device: High Definition transcranial Direct Current Stimulation; 1x1 tDCS low-intensity stimulator and 4x1 multichannel stimulation adaptor (Soterix Medical Inc, New York, NY)

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Visual Analogue scale (VAS) for tinnitus loudness	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	Baseline (before intervention), immediately post intervention, 7 weeks follow-up
Change in Hospital Anxiety and Depression Scale (HADS)	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	Baseline (before intervention), immediately post intervention, 7 weeks follow-up
Change in Tinnitus Questionnaire (TQ)	Tinnitus severity self-report questionnaire, ranging from 0-84 with a higher score representing a more distressing tinnitus	Baseline (before intervention), immediately post intervention, 7 weeks follow-up
Change in Hyperacusis Questionnaire (HQ)	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.	Baseline (before intervention), immediately post intervention, 7 weeks follow-up

Collaborators and Investigators

• Sponsor: University Hospital, Antwerp
• Collaborators: Universiteit Antwerpen

Publications and helpful links

General Publications

• Jacquemin L, Shekhawat GS, Van de Heyning P, Mertens G, Fransen E, Van Rompaey V, Topsakal V, Moyaert J, Beyers J, Gilles A. Effects of Electrical Stimulation in Tinnitus Patients: Conventional Versus High-Definition tDCS. Neurorehabil Neural Repair. 2018 Aug;32(8):714-723. doi: 10.1177/1545968318787916. Epub 2018 Jul 18.
• Shekhawat GS, Sundram F, Bikson M, Truong D, De Ridder D, Stinear CM, Welch D, Searchfield GD. Intensity, Duration, and Location of High-Definition Transcranial Direct Current Stimulation for Tinnitus Relief. Neurorehabil Neural Repair. 2016 May;30(4):349-59. doi: 10.1177/1545968315595286. Epub 2015 Jul 15.
• Shekhawat GS, Vanneste S. High-definition transcranial direct current stimulation of the dorsolateral prefrontal cortex for tinnitus modulation: a preliminary trial. J Neural Transm (Vienna). 2018 Feb;125(2):163-171. doi: 10.1007/s00702-017-1808-6. Epub 2017 Nov 10.

Study record dates

Study Major Dates

• Study Start (Actual): October 21, 2016
• Primary Completion (Actual): April 8, 2019
• Study Completion (Actual): April 9, 2019

Study Registration Dates

• First Submitted: August 12, 2020
• First Submitted That Met QC Criteria: September 24, 2020
• First Posted (Actual): September 25, 2020

Study Record Updates

• Last Update Posted (Actual): September 25, 2020
• Last Update Submitted That Met QC Criteria: September 24, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Keywords: transcranial direct current stimulation; neuromodulation; tinnitus; non-invasive brain stimulation; large cohort; high-definition tDCS
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Otorhinolaryngologic Diseases; Ear Diseases; Sensation Disorders; Hearing Disorders; Tinnitus
• Other Study ID Numbers: HDtDCS_extensive

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No