NCT01093872

Brief Summary

In this study, we perform an open-label rTMS over the left AC on patients with tinnitus. Outcome measures will be evaluated statistically. The results will be instrumental in deciding the efficacy of this technique in a local patient group.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2008

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

August 1, 2008

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

March 24, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 26, 2010

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2013

Completed
Last Updated

December 10, 2012

Status Verified

August 1, 2012

Enrollment Period

5 years

First QC Date

March 24, 2010

Last Update Submit

December 6, 2012

Conditions

Tinnitus

Outcome Measures

Primary Outcomes (1)

  • Tinnitus Inventory Handicap scoring & Visual Analogue Scale (VAS)

    THI and VAS is measure before the treatment and weekly for 4 weeks after the treatment.

    Baseline, 1,2,3 & 4weeks after treatment

Interventions

Repetitive Transcranial Magnetic Stimulation (rTMS)DEVICE

Upon recruitment, all patients will undergo a 1 week treatment consisting of 5 rTMS sessions Repetitive TMS consists of 1000 stimulations/ day at 1 Hz and 110% of the motor threshold, for five consecutive days over the left AC.

Eligibility Criteria

Age21 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • All patients with tinnitus

You may not qualify if:

  • Patients with contraindications to TMS: pacemaker, intracranial surgery, implants and seizures

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Singapore General Hospital

Singapore, Outram Road, 169608, Singapore

RECRUITING

MeSH Terms

Conditions

Tinnitus

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Magnetic Field TherapyTherapeutics

Study Officials

  • YL Lo, MD

    National Neuroscience Institute, Singapore General Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

YL Lo, MD

CONTACT

63265003lo.yew.long@sgh.com.sg

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

March 24, 2010

First Posted

March 26, 2010

Study Start

August 1, 2008

Primary Completion

August 1, 2013

Study Completion

August 1, 2013

Last Updated

December 10, 2012

Record last verified: 2012-08

Locations

SG(1)