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

Repetitive Transcranial Magnetic Stimulation (rTMS) for the Treatment of Negative Symptoms in Schizophrenia - a Multicenter Study

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00783120

Acronym

RESIS

Enrollment

197

Registered

2008-10-31

Start date

2008-01-31

Completion date

2011-12-31

Last updated

2013-11-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Schizophrenia

Keywords

schizophrenia, negative symptoms, TMS, magnetic stimulation

Brief summary

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).

Interventions

OTHERRepetitive 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.

OTHERSham repetitive transcranial magnetic stimulation

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 60 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Improvement in negative symptoms (baseline vs. day 21, PANNS negative sum score)	105 Days

Secondary

Measure	Time frame
efficacy on cognition, EPS, neuroplasticity (sMRI/MRS), depression, life quality and social function	105 days

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 9, 2026