High Frequency rTMS Treatment for Cognitive Impairments in Chronic Schizophrenia Patients

Schizophrenia Clinical Trial

Official title:

A Randomized, Double-blind Sham-controlled Trial of High Frequency rTMS for Cognitive Impairments in Chronic Schizophrenia Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03774927
• Other study ID #: CASPsy1
• Status: Completed
• Phase: N/A
• Start date: January 1, 2017
• Est. completion date: November 30, 2018

Study information

• Verified date: April 2019
• Source: Beijing HuiLongGuan Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

A randomized, double-blind sham-controlled trial of high frequency rTMS treatment for cognitive impairments in 120 chronic schizophrenia patients

Description:

OBJECTIVE: This study aimed to evaluate the efficacy of high-frequency repetitive transcranial magnetic stimulation (rTMS) over left dorsolateral prefrontal cortex in the treatment of cognitive impairments in 120 chronic patients with schizophrenia.

METHODS:

1. Clinical Trial: The study consists of 8 weeks of treatment.

2. Assessment Procedures:

2.1 Primary Outcome Variable-Psychopathology: The psychopathology of patients was assessed by three clinical trained staff, who were blind to treatment protocols, using the Positive and Negative Syndrome Scale (PANSS). Patients are interviewed at screening, at at baseline, 2 weeks, 4 weeks, 6 weeks and 8 weeks.

2.2 Cognitive tests: RBANS was used to assess the cognitive function by three psychologists, which is comprised of a total score and 5 age-adjusted index scores for attention, language, delayed and immediate memory and visuospatial/construction. A translated and adapted Chinese version of RBANS has been evaluated for the test-retest reliability and clinical validity between schizophrenia patients and control subjects. Cognitive performance was measured at baseline and at 8-weeks.

2.3 Side Effects: TESS was used to assess the side effect at baseline and every 2 weeks.

2.5 Weight gain measurement: weight gain every week

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: November 30, 2018
• Est. primary completion date: October 30, 2018
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• Diagnosis of schizopherenia by two senior psychiatrists

• Male

• Right-handed

• Between 18 and 60 years and Han Chinese

• Duration of symptoms at least 60 months

• Received stable doses of antipsychotic drugs at least 12 months

• With unresolved negative symptoms (Negative scale of PANSS =20 and positive scale of PANSS < 24)

Exclusion Criteria:

• A DSM-IV Axis I diagnosis other than schizophrenia

• Documented disease of physical diseases including, but not limited to seizure, epilepsy, aneurysm brain tumor, and stroke, dementia, parkinson's disease, Huntington's disease, multiple sclerosis

• Acute, unstable and/or significant and untreated medical illness (e.g., infection, unstable diabetes, uncontrolled hypertension)

• Severe headache for unknown reasons and cardiovascular diseases, intra-cranial metals, pacemakers, severe and those receiving electroconvulsive therapy in the past 3 months

• Past history of autoimmune and allergies, hypertension, lung disease, diabetes or cerebrovascular disease), past history of neurological illness (head trauma with loss of consciousness for more than 5 minutes) or family history of epilepsy increasing the risk of seizures

• Education level less than 5 years by subject report,

• Receiving or planning to start the psychotherapy during the rTMS treatment or past received psychotherapy 6 months before the current study

• Subjects who suffered from alcohol or illegal drug abuse/dependence

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Schizophrenia

Intervention

Device:
• 10 Hz treatment group
10 Hz stimulations over left DLPFC occurred at a power of 110% of MT for 27-s intervals with 20s inter-train interval. 20 minutes were administered each day (Monday-Friday) for 8 consecutive weeks.
• 20 Hz treatment group
20 Hz stimulations over left DLPFC occurred at a power of 110% of MT for 20 intervals with 28s inter-train interval. 20 minutes were administered each day (Monday-Friday) for 8 consecutive weeks.
• Control Group
all procedures were identical to 10Hz group except they were the non-magnetized steel cylinders, instead of cylindrical magnets, that were rotated.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Beijing HuiLongGuan Hospital

References & Publications (3)

Dlabac-de Lange JJ, Liemburg EJ, Bais L, Renken RJ, Knegtering H, Aleman A. Effect of rTMS on brain activation in schizophrenia with negative symptoms: A proof-of-principle study. Schizophr Res. 2015 Oct;168(1-2):475-82. doi: 10.1016/j.schres.2015.06.018. Epub 2015 Jul 14. — View Citation

Mogg A, Purvis R, Eranti S, Contell F, Taylor JP, Nicholson T, Brown RG, McLoughlin DM. Repetitive transcranial magnetic stimulation for negative symptoms of schizophrenia: a randomized controlled pilot study. Schizophr Res. 2007 Jul;93(1-3):221-8. Epub 2 — View Citation

Wobrock T, Guse B, Cordes J, Wölwer 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 repe — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Repeatable Battery for the Assessment of Neuropsychological Status for cognition	cognitive performance	8 weeks
Primary	Positive and Negative Syndrome Scale for clinical symptoms	clinical symptoms	8 weeks
Secondary	Treatment Emergent Symptoms Scale for side effects	Side effect	8 weeks