NCT01944501

Brief Summary

This study aimed at trying transcranial magnetic stimulation and transcranial direct current stimulation as potential treatments to decrease tinnitus in patients with significant hearing loss.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2012

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

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

March 1, 2012

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

September 9, 2013

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 17, 2013

Completed
Last Updated

September 17, 2013

Status Verified

September 1, 2013

Enrollment Period

9 months

First QC Date

September 9, 2013

Last Update Submit

September 12, 2013

Conditions

TinnitusHearing Loss

Keywords

tinnitushearing lossTranscranial magnetic stimulationTranscranial direct current stimulation

Outcome Measures

Primary Outcomes (1)

  • Change in Tinnitus Handicap Inventory (THI) scores

    THI was measured before intervention (baseline) and after 5 daily sessions (day 5)

Secondary Outcomes (1)

  • Change in Visual Analog Scale scores

    Visual analog scale of tinnitus was recorded at baseline and after daily 5 TMS or TDCS sessions ( day 5)

Study Arms (4)

Transcranial Magnetic Stimulation

ACTIVE COMPARATOR

Patients receiving real transcranial magnetic stimulation

Procedure: Transcranial Magnetic Stimulation

Sham TMS

PLACEBO COMPARATOR

Patients receiving sham transcranial magnetic stimulation

Procedure: Transcranial Magnetic Stimulation

Transcranial Direct Current Stimulation

ACTIVE COMPARATOR

Patients receiving real transcranial direct current stimulation

Procedure: Transcranial Direct Current Stimulation

Sham TDCS

PLACEBO COMPARATOR

Patients receiving sham transcranial direct current stimulation

Procedure: Transcranial Direct Current Stimulation

Interventions

Transcranial Magnetic StimulationPROCEDURE

TMS over the left temporoparietal cortex

Sham TMSTranscranial Magnetic Stimulation
Transcranial Direct Current StimulationPROCEDURE

TDCS over the left temporoparietal cortex

Sham TDCSTranscranial Direct Current Stimulation

Eligibility Criteria

Age45 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • chronic tinnitus
  • hearing loss

You may not qualify if:

  • neurological diseases
  • use of drugs affecting the central nervous system
  • evidence of dementia
  • clinical diagnosis of depression

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universidade de Brasília

Brasília, Federal District, 70000, Brazil

Location

MeSH Terms

Conditions

TinnitusHearing Loss

Interventions

Transcranial Magnetic StimulationTranscranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Magnetic Field TherapyTherapeuticsElectric Stimulation TherapyConvulsive TherapyPsychiatric Somatic TherapiesBehavioral Disciplines and ActivitiesElectroshockPsychological Techniques

Study Officials

  • Joaquim P Brasil-Neto, PhD

    University of Brasilia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr.

Study Record Dates

First Submitted

September 9, 2013

First Posted

September 17, 2013

Study Start

March 1, 2012

Primary Completion

December 1, 2012

Study Completion

December 1, 2012

Last Updated

September 17, 2013

Record last verified: 2013-09

Locations

BR(1)