Influence of Tonic and Burst Transcranial Magnetic Stimul... | NCT00878696

Studies
Influence of Tonic and Burst Transcranial Magnetic Stimulation (TMS) Characteristics on Acute Inhibition of Subjective Tinnitus

NCT00878696

Sponsor

University Hospital, Antwerp

Status

Completed

Last Update Posted

Apr 9, 2009Estimated

Enrollment

64Actual

Phase

Not provided

Conditions

Tinnitus

Interventions

TMS transcranial magnetic stimulation

Countries

Belgium

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2009

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2007

Primary Completion Date

Sep 2007Actual

Completion Date

Apr 2008Actual

First Submitted Date

Apr 7, 2009

First Submission Date that Met QC Criteria

Apr 8, 2009

First Posted Date

Apr 9, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 8, 2009

Last Update Posted Date

Apr 9, 2009Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Transcranial magnetic stimulation (TMS) is already broadly used in different areas of neuroscience research. Last year, special attention was drawn to TMS in tinnitus. The aim of the researchers' study is to investigate the stimulation characteristics of TMS in tinnitus patients, in particularly the effect of tonic and burst stimulation of the superior temporal lobe.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

64Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Tinnitus		Tinnitus patients	Procedure: TMS transcranial magnetic stimulation

Interventions

Name	Type	Description	Arm Group Labels	Other Names
TMS transcranial magnetic stimulation	Procedure	200 pulses of tonic TMS (see Graph 1) were administered with an intensity at 50% of the maximal TMS device output (50%DO). The frequency of the tonic pulses was randomly chosen between 1Hz, 5Hz, 10Hz or 20Hz. Burst stimulation was delivered at a burst frequency of 5, 10 or 20Hz. Each burst consisted of 3, 5 or 10 pulses. The individual pulse rate within a burst was 50 or 100Hz.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
VAS visual analogue scale		immediately before and immediately after single session TMS

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients presented to our Multidisciplinary Tinnitus Clinic with tinnitus as a main complaint.

Exclusion Criteria:

Patients with known history of epilepsy, pacemakers, cochlear implants, neurostimulators or intracerebral pathology were excluded from the study.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

78 Years

Standard Ages

AdultOlder Adult

Study Population

Patients presented to our Multidisciplinary Tinnitus Clinic with tinnitus as a main complaint.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Antwerp University Hospital		Edegem	Antwerp	2650	Belgium

Condition Browse Module

MeSH Terms

ID	Term
D014012	Tinnitus

Ancestor Terms

ID	Term
D006311	Hearing Disorders
D004427	Ear Diseases
D010038	Otorhinolaryngologic Diseases
D012678	Sensation Disorders

Browse Leaves

Not provided

Browse Branches

Not provided