HD-tDCS as a Treatment for Chronic Tinnitus

Tinnitus, Subjective Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04565132
• Other study ID #: HDtDCS_extensive
• Status: Completed
• Phase: N/A
• Start date: October 21, 2016
• Est. completion date: April 9, 2019

Study information

• Verified date: August 2020
• Source: University Hospital, Antwerp
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 117
• Est. completion date: April 9, 2019
• Est. primary completion date: April 8, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• chronic, subjective, non-pulsatile tinnitus

• met the criteria for HD-tDCS safety

Exclusion Criteria:

• a middle ear pathology

• another tinnitus treatment ongoing

Related Conditions & MeSH terms

• Tinnitus
• Tinnitus, Subjective

Intervention

Device:
• High Definition transcranial Direct Current Stimulation
1x1 tDCS low-intensity stimulator and 4x1 multichannel stimulation adaptor (Soterix Medical Inc, New York, NY)

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Antwerp	Universiteit Antwerpen

References & Publications (3)

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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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