HD-tDCS as a Treatment for Chronic Tinnitus

• Sponsor: University Hospital, Antwerp (Other)
• Overall Status: Completed
• CT.gov ID: NCT04565132
• Collaborator: Universiteit Antwerpen (Other)
• Enrollment: 117
• Arm: 1
• Actual Duration (Months): 29.6

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Tinnitus, Subjective	Device: High Definition transcranial Direct Current Stimulation	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 117 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: High Definition Transcranial Direct Current Stimulation (HD-tDCS) for Chronic Tinnitus: Outcomes From a Prospective Longitudinal Large Cohort Study
• Actual Study Start Date: Oct 21, 2016
• Actual Primary Completion Date: Apr 8, 2019
• Actual Study Completion Date: Apr 9, 2019

Arms and Interventions

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)

Outcome Measures

Primary Outcome Measures

1. 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

1. 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

2. 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

3. 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

4. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• chronic, subjective, non-pulsatile tinnitus

• met the criteria for HD-tDCS safety

Exclusion Criteria:

• a middle ear pathology

• another tinnitus treatment ongoing

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• University Hospital, Antwerp
• Universiteit Antwerpen

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

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.

• Responsible Party: University Hospital, Antwerp
• ClinicalTrials.gov Identifier: NCT04565132
• Other Study ID Numbers: HDtDCS_extensive
• First Posted: Sep 25, 2020
• Last Update Posted: Sep 25, 2020
• Last Verified: Aug 1, 2020

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by University Hospital, Antwerp: tinnitus; neuromodulation; non-invasive brain stimulation; transcranial direct current stimulation; large cohort; high-definition tDCS
• Additional relevant MeSH terms: Tinnitus

Study Results

No Results Posted as of Sep 25, 2020