Clinical trial NCT04565132: HD-tDCS as a Treatment for Chronic Tinnitus
Official title: High Definition Transcranial Direct Current Stimulation (HD-tDCS) for Chronic Tinnitus: Outcomes From a Prospective Longitudinal Large Cohort Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tinnitus, Subjective
Keywords: tinnitus
neuromodulation
non-invasive brain stimulation
transcranial direct current stimulation
large cohort
high-definition tDCS
Lead sponsor: University Hospital, Antwerp
Sponsor class: OTHER
Collaborators: name: Universiteit Antwerpen
First posted: 2020-09-25
Enrollment: 117
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* a middle ear pathology
* another tinnitus treatment ongoing

Primary outcomes:
measure: Change in Tinnitus Functional Index (TFI)
timeFrame: Baseline (before intervention), immediately post intervention, 7 weeks follow-up
Secondary outcomes:
measure: Change in Visual Analogue scale (VAS) for tinnitus loudness
timeFrame: Baseline (before intervention), immediately post intervention, 7 weeks follow-up
measure: Change in Hospital Anxiety and Depression Scale (HADS)
timeFrame: Baseline (before intervention), immediately post intervention, 7 weeks follow-up
measure: Change in Tinnitus Questionnaire (TQ)
timeFrame: Baseline (before intervention), immediately post intervention, 7 weeks follow-up
measure: Change in Hyperacusis Questionnaire (HQ)
timeFrame: Baseline (before intervention), immediately post intervention, 7 weeks follow-up
Other outcomes:
Locations:
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.