Effect of high frequency transcranial magnetic stimulation on negative symptoms and cognitive functioning in schizophrenia: a combined treatment and neuroimaging study

Effect of high frequency transcranial magnetic stimulation on negative symptoms and cognitive functioning in schizophrenia: a combined treatment and neuroimaging study - Effect TMS on negative symptoms and cognitive functioning in schizophrenia

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON37140

Enrollment

Registered

2008-05-29

Start date

2008-05-01

Completion date

Unknown

Last updated

2024-11-18

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

Conditions

distortion of reality mental disorder

Interventions

The rTMS group of 16 patients will receive bilateral rTMS stimulation during 15 days, sessions being given twice daily. The sham group of 16 patients will constitute the placebo group and receive 15

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Patients included must have prominent negative symptoms and patients must have a negative subscore >= 15 on the Positive and Negative Syndrome Scale for Schizophrenia (PANSS). Only patients who are fully capable of making their own decision regarding participation in the research will be included.

Exclusion criteria

Exclusion criteria: Exclusion criteria include rTMS and MRI contraindications (e.g. a personal or family history of epileptic seizures, history of brain surgery, intracerebral or pacemaker implants, inner ear prosthesis or other metal prosthetics/implants), neurological disorders, a head injury with loss of consciousness in the past, substance dependency within the previous 6 months, previous treatment with rTMS, severe behavioural disorders, inability to provide informed consent and claustrophobia. Female patients who are pregnant will be excluded.

Design outcomes

Primary

Measure	Time frame
The primary outcome of the study is a significant decline of negative symptoms and cognitive dysfunctioning after bilateral high frequency rTMS treatment of the DLPFC.	—

Secondary

Measure	Time frame
The secondary outcome of the study is increased cortical activation in the DLPFC after rTMS treatment, measured through a fMRI study. The relationships between rTMS treatment, improvement in cognitive functioning, decrease of negative symptoms and changes in the measurement of the Blood Oxygenation Level Dependent (BOLD) signal through fMRI will be studied. In addition, we aim to investigate any possible improvement in cognitive functioning, as cognitive dysfunction in schizophrenia has also been related to frontal brain impairment.	—

Measure

Time frame

The secondary outcome of the study is increased cortical activation in the DLPFC after rTMS treatment, measured through a fMRI study. The relationships between rTMS treatment, improvement in cognitive functioning, decrease of negative symptoms and changes in the measurement of the Blood Oxygenation Level Dependent (BOLD) signal through fMRI will be studied. In addition, we aim to investigate any possible improvement in cognitive functioning, as cognitive dysfunction in schizophrenia has also been related to frontal brain impairment.

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Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)