NCT04565132

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
117

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2016

Typical duration for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 21, 2016

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 8, 2019

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 9, 2019

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

August 12, 2020

Completed
1 month until next milestone

First Posted

Study publicly available on registry

September 25, 2020

Completed
Last Updated

September 25, 2020

Status Verified

August 1, 2020

Enrollment Period

2.5 years

First QC Date

August 12, 2020

Last Update Submit

September 24, 2020

Conditions

Tinnitus, Subjective

Keywords

tinnitusneuromodulationnon-invasive brain stimulationtranscranial direct current stimulationlarge cohorthigh-definition tDCS

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Change in Visual Analogue scale (VAS) for tinnitus loudness

    Baseline (before intervention), immediately post intervention, 7 weeks follow-up

  • Change in Hospital Anxiety and Depression Scale (HADS)

    Baseline (before intervention), immediately post intervention, 7 weeks follow-up

  • Change in Tinnitus Questionnaire (TQ)

    Baseline (before intervention), immediately post intervention, 7 weeks follow-up

  • Change in Hyperacusis Questionnaire (HQ)

    Baseline (before intervention), immediately post intervention, 7 weeks follow-up

Study Arms (1)

HD-tDCS

EXPERIMENTAL

Each patient received a total of six sessions of anodal HD-tDCS of right DLPFC.

Device: High Definition transcranial Direct Current Stimulation

Interventions

High Definition transcranial Direct Current StimulationDEVICE

1x1 tDCS low-intensity stimulator and 4x1 multichannel stimulation adaptor (Soterix Medical Inc, New York, NY)

HD-tDCS

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • a middle ear pathology
  • another tinnitus treatment ongoing

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (4)

  • 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.

    PMID: 30019630BACKGROUND

  • 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.

    PMID: 26180052BACKGROUND

  • 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.

    PMID: 29127483BACKGROUND

  • Cardon E, Jacquemin L, Schecklmann M, Langguth B, Mertens G, Vanderveken OM, Lammers M, Van de Heyning P, Van Rompaey V, Gilles A. Random Forest Classification to Predict Response to High-Definition Transcranial Direct Current Stimulation for Tinnitus Relief: A Preliminary Feasibility Study. Ear Hear. 2022 Nov-Dec 01;43(6):1816-1823. doi: 10.1097/AUD.0000000000001246. Epub 2022 Jun 7.

    PMID: 35666538DERIVED

MeSH Terms

Conditions

Tinnitus

Condition Hierarchy (Ancestors)

Hearing DisordersEar DiseasesOtorhinolaryngologic DiseasesSensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 12, 2020

First Posted

September 25, 2020

Study Start

October 21, 2016

Primary Completion

April 8, 2019

Study Completion

April 9, 2019

Last Updated

September 25, 2020

Record last verified: 2020-08