Efficacy and Safety of Bilateral Theta Burst Stimulation... | NCT01478880

Studies
Efficacy and Safety of Bilateral Theta Burst Stimulation for the Treatment of Auditory Hallucinations

NCT01478880

Sponsor

University Hospital Tuebingen

Status

Completed

Last Update Posted

Jul 16, 2013Estimated

Enrollment

16Estimated

Phase

Phase 2

Conditions

Auditory Hallucinations

Interventions

continuous theta burst stimulation (cTBS)
sham cTBS

Countries

Germany

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

Jul 2013

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

May 2011

Primary Completion Date

Jul 2013Actual

Completion Date

Jul 2013Actual

First Submitted Date

Nov 21, 2011

First Submission Date that Met QC Criteria

Nov 21, 2011

First Posted Date

Nov 23, 2011Estimated

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

Jul 13, 2013

Last Update Posted Date

Jul 16, 2013Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Christian Plewnia, MD, Principal Investigator, University Hospital TuebingenPrincipal Investigator

Lead Sponsor

University Hospital TuebingenOTHER

Collaborators

Not provided

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

First clinical studies indicate an effect of repetitive transcranial magnetic stimulation(rTMS) in the treatment of auditory hallucinations (AH). However, effect size, optimal stimulation site and parameters are unclear. With this randomized, placebo-controlled clinical trial we test the efficacy and safety of bilateral continuous theta burst stimulation (cTBS), a patterned form rTMS, against auditory hallucinations. The treatment will be applied add-on to individual antipsychotic and behavioral therapy. Patients will be treated for 6 weeks each weekday (30 sessions) with 40s of cTBS (halfway between T3/P3 and T4/P4). For weeks 1-3, half of the subjects will be randomized to a sham-stimulation (coil tilted 45°). During weeks 4-6, all subjects receive real cTBS.

Detailed Description

Not provided

Design Module

Study Type

Interventional

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

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

16Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
cTBS	Experimental		Procedure: continuous theta burst stimulation (cTBS)
Sham cTBS	Sham Comparator		Procedure: sham cTBS

Interventions

Name	Type	Description	Arm Group Labels	Other Names
continuous theta burst stimulation (cTBS)	Procedure	bilateral continuous theta burst stimulation (bursts of 3 stimuli, 50Hz every 200ms for 40s, 80% active motor threshold) to the temporoparietal cortex (EEG 10/20: halfway T3/P3 and T4/P4)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Psychotic Symptom Rating Scales (PSYRATS), subscale for auditory hallucinations	Change of PSYRATS AH score compared to baseline after 3 weeks of treatment	3 weeks

Secondary Outcomes

Measure	Description	Time Frame
Hallucination change score (HCS)		3 and 6 weeks
Positive and Negative Symptom Scale (PANSS)		3 and 6 weeks
PSYRATS subscale for auditory hallucinations

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

auditory hallucinations at least once a week
Schizophrenia (DSM-IV)
stable treatment setting (in- or out-patient)
no change of antipsychotics during and at least 1 week before treatment initiation

Exclusion Criteria:

epilepsy
benzodiazepines > 1,5mg lorazepam / d
pregnancy
metal parts in the brain
cardiac pacemaker
deep brain stimulation

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Christian Plewnia, MD	Universtity of Tuebingen	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Tübingen, Department of Psychiatry and Psychotherapy		Tübingen			Germany

Condition Browse Module

MeSH Terms

ID	Term
D006212	Hallucinations

Ancestor Terms

ID	Term
D010468	Perceptual Disorders
D019954	Neurobehavioral Manifestations
D009461	Neurologic Manifestations
D009422	Nervous System Diseases

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