MedDataX Logo

Repetitive Transcranial Magnetic Stimulation (rTMS) for the Treatment of Negative Symptoms in Schizophrenia

NCT ID: NCT00783120

Last Updated: 2013-11-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

197 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-01-31

Study Completion Date

2011-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Schizophrenia is a major psychotic disorder that presents an enormous burden to the patients and their relatives. Despite treatment with second generation antipsychotics, negative symptoms and cognitive impairment often persist and determine an unfavourable course including reduction in life quality. Prefrontal repetitive transcranial magnetic stimulation (rTMS), a promising noninvasive biological technique, applied adjuvant to ongoing antipsychotic treatment was demonstrated to be safe and was associated with improvement in negative symptoms in the majority of the small placebo-controlled trials.

The primary objective of the trial is to investigate the efficacy of high-frequency rTMS (add-on to antipsychotic therapy) in the treatment of negative symptoms in schizophrenia compared to sham stimulation (placebo).

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Schizophrenia

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

schizophrenia, negative symptoms, TMS, magnetic stimulation

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

1

10 Hz rTMS of left dorsolateral prefrontal cortex (DLPFC) (15 sessions/3 weeks, 1000 stimuli per session, stimulation intensity 110 % related to the individual resting motor threshold).

Group Type EXPERIMENTAL

Repetitive transcranial magnetic stimulation

Intervention Type OTHER

10 Hz rTMS of left dorsolateral prefrontal cortex (DLPFC) (15 sessions/3 weeks, 1000 stimuli per session, stimulation intensity 110 % related to the individual resting motor threshold); in total 15.000 stimuli.

2

placebo (sham)-rTMS of left DLPFC (15 sessions/3 weeks, 1000 stimuli per session)

Group Type SHAM_COMPARATOR

Sham repetitive transcranial magnetic stimulation

Intervention Type OTHER

placebo (sham)-rTMS of left DLPFC (15 sessions/3 weeks, 1000 stimuli per session; in total 15.000 stimuli

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Repetitive transcranial magnetic stimulation

10 Hz rTMS of left dorsolateral prefrontal cortex (DLPFC) (15 sessions/3 weeks, 1000 stimuli per session, stimulation intensity 110 % related to the individual resting motor threshold); in total 15.000 stimuli.

Intervention Type OTHER

Sham repetitive transcranial magnetic stimulation

placebo (sham)-rTMS of left DLPFC (15 sessions/3 weeks, 1000 stimuli per session; in total 15.000 stimuli

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Male or female in-patients and out-patients, 18 - 60 years of age
* Diagnostic criteria for schizophrenia according to ICD-10/DSM IV
* PANSS negative sum score \> 20 points, 1 of items N1 - N7 (range 1 to 7) ≥ 4 (at least moderate)
* Improvement in PANSS negative sum score less than 10 % in the last 2 weeks prior to study entry, stable antipsychotic medication
* Informed Consent

Exclusion Criteria

* Clinically relevant psychiatric comorbidity, verbal IQ \< 85
* History of epileptic seizures, organic brain disease
* Instable medical comorbidity or condition
* Previous treatment by rTMS
* Factors not compatible with the use of TMS, e.g. cardiac pace makers or other metallic implants, pregnancy
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Göttingen

OTHER

Sponsor Role collaborator

Institut fuer anwendungsorientierte Forschung und klinische Studien GmbH

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Dept. of Psychiatry and Psychotherapy

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Peter G Falkai, Prof MD.

Role: STUDY_DIRECTOR

Dept. of Psychiatry and Psychotherapy, University Hospital of the Georg-August-University Göttingen

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Department of Psychiatry and Psychotherapy, University of Regensburg

Regensburg, Bavaria, Germany

Site Status

Dept. of Psychiatry and Psychotherapy, University Hospital of the Georg-August-University Göttingen

Göttingen, Lower Saxony, Germany

Site Status

Department of Psychiatry, Heinrich-Heine University Hospital

Düsseldorf, North Rhine-Westphalia, Germany

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Germany

References

Explore related publications, articles, or registry entries linked to this study.

Koutsouleris N, Wobrock T, Guse B, Langguth B, Landgrebe M, Eichhammer P, Frank E, Cordes J, Wolwer W, Musso F, Winterer G, Gaebel W, Hajak G, Ohmann C, Verde PE, Rietschel M, Ahmed R, Honer WG, Dwyer D, Ghaseminejad F, Dechent P, Malchow B, Kreuzer PM, Poeppl TB, Schneider-Axmann T, Falkai P, Hasan A. Predicting Response to Repetitive Transcranial Magnetic Stimulation in Patients With Schizophrenia Using Structural Magnetic Resonance Imaging: A Multisite Machine Learning Analysis. Schizophr Bull. 2018 Aug 20;44(5):1021-1034. doi: 10.1093/schbul/sbx114.

Reference Type DERIVED
PMID: 28981875 (View on PubMed)

Hasan A, Wobrock T, Guse B, Langguth B, Landgrebe M, Eichhammer P, Frank E, Cordes J, Wolwer W, Musso F, Winterer G, Gaebel W, Hajak G, Ohmann C, Verde PE, Rietschel M, Ahmed R, Honer WG, Dechent P, Malchow B, Castro MFU, Dwyer D, Cabral C, Kreuzer PM, Poeppl TB, Schneider-Axmann T, Falkai P, Koutsouleris N. Structural brain changes are associated with response of negative symptoms to prefrontal repetitive transcranial magnetic stimulation in patients with schizophrenia. Mol Psychiatry. 2017 Jun;22(6):857-864. doi: 10.1038/mp.2016.161. Epub 2016 Oct 11.

Reference Type DERIVED
PMID: 27725655 (View on PubMed)

Wobrock T, Guse B, Cordes J, Wolwer W, Winterer G, Gaebel W, Langguth B, Landgrebe M, Eichhammer P, Frank E, Hajak G, Ohmann C, Verde PE, Rietschel M, Ahmed R, Honer WG, Malchow B, Schneider-Axmann T, Falkai P, Hasan A. Left prefrontal high-frequency repetitive transcranial magnetic stimulation for the treatment of schizophrenia with predominant negative symptoms: a sham-controlled, randomized multicenter trial. Biol Psychiatry. 2015 Jun 1;77(11):979-88. doi: 10.1016/j.biopsych.2014.10.009. Epub 2014 Oct 23.

Reference Type DERIVED
PMID: 25582269 (View on PubMed)

Cordes J, Falkai P, Guse B, Hasan A, Schneider-Axmann T, Arends M, Winterer G, Wolwer W, Ben Sliman E, Ramacher M, Schmidt-Kraepelin C, Ohmann C, Langguth B, Landgrebe M, Eichhammer P, Frank E, Burger J, Hajak G, Rietschel M, Wobrock T. Repetitive transcranial magnetic stimulation for the treatment of negative symptoms in residual schizophrenia: rationale and design of a sham-controlled, randomized multicenter study. Eur Arch Psychiatry Clin Neurosci. 2009 Nov;259 Suppl 2:S189-97. doi: 10.1007/s00406-009-0060-y.

Reference Type DERIVED
PMID: 19876678 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

RESIS

Identifier Type: -

Identifier Source: org_study_id