The Mid-term Effect of Repeated Transcranial Magnetic Stimulation on Schizophrenia
4. Mai 2019 aktualisiert von: Shanghai Mental Health Center
A Follow-up Study of Clinical Effects of Repetitive Transcranial Magnetic Stimulation on Schizophrenia
Medications have a poor effect on negative symptoms and cognitive function in schizophrenia.
In the past, most of the studies on repetitive transcranial magnetic stimulation intervention in patients with schizophrenia used conventional stimulation sites and patterns, and the intervention effect was still controversial.
A few studies have achieved positive results with the new stimulation model (TBS model) and the therapeutic target (cerebellar vermis), but the follow-up period did not exceed 2 weeks, and no similar studies have emerged in China.
Therefore, this study hypothesized that the TBS-mode rTMS intervention in the cerebellar vermis can improve the negative symptoms, cognitive function, and depressive symptoms of schizophrenia, and the efficacy can be maintained.
Studienübersicht
Status
Abgeschlossen
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
Medications have a poor effect on negative symptoms and cognitive function in schizophrenia. In the past, most of the studies on repetitive transcranial magnetic stimulation intervention in patients with schizophrenia used conventional stimulation sites and patterns, and the intervention effect was still controversial. A few studies have achieved positive results with the new stimulation model (TBS model) and the therapeutic target (cerebellar vermis), but the follow-up period did not exceed 2 weeks, and no similar studies have emerged in China. Therefore, this study hypothesized that the TBS-mode rTMS intervention in the cerebellar vermis can improve the negative symptoms, cognitive function, and depressive symptoms of schizophrenia, and the efficacy can be maintained.
- Aim of the study: 1.1 To explore the clinical efficacy of cerebellar vermal theta burst stimulation for negative symptoms, cognitive function and depressive symptoms in patients with schizophrenia. 1.2 The patients were followed up for 24 weeks to explore the duration of rTMS efficacy
- Introduction of the study: This is a multi-center, randomized, sham-controlled, double-blinded trial. Participants diagnosed with schizophrenia from Shanghai Mental Health Center and six district-level mental health centers were randomized according to the odd-even sequence of enrollment, with odd numbers into the study group and even numbers into the control group. Patients in the study group received 100%MT rTMS with the intermittent theta burst stimulation paradigm, while another patients were subjected to pseudo-stimulation treatment, both being given 2-week intervention (5 times per week). The type and dose of antipsychotic drugs taken by patients remained unchanged during the intervention period. Efficacy were assessed with the Positive and Negative Symptoms Scale (PANSS), Hamilton Depression Scale (HAMD-24) and MATRICS Consensus Cognitive Battery (MCCB).
Studientyp
Interventionell
Einschreibung (Tatsächlich)
64
Phase
- Unzutreffend
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienorte
-
-
-
Shanghai, China
- Shanghai Mental Health Center
-
-
Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
18 Jahre bis 50 Jahre (Erwachsene)
Akzeptiert gesunde Freiwillige
Nein
Studienberechtigte Geschlechter
Alle
Beschreibung
Inclusion Criteria:
- the patient met the diagnostic criteria for schizophrenia in ICD-10;
- 18-50 years old;
- Right handed;
- The current condition is stable, and the types and doses of antipsychotic drugs are unchanged;
- In the PANSS scale, the score of Pl, P3, P5, P6, and G9 is not more than 5 points, and the score of P2 is not more than 4 points;
Exclusion Criteria:
- In addition to schizophrenia, patients with other mental illnesses；
- Contraindications to rTMS;
- Patients receiving ECT(electro-convulsive therapy) in last month;
- Pregnant or lactating woman.
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Doppelt
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Aktiver Komparator: study group-active rTMS
Participants in the study group received 100%MT(motor threshold) repetitive transcranial magnetic stimulation with the intermittent theta burst stimulation paradigm.
|
There are two types of stimulation equipment, one is the transcranial magnetic stimulator model Magpro X100 produced by Danish Medtronic, and the other is the CCY-I TMS stimulator produced by Wuhan Eride, model B9076.
The stimulating magnetic head uses an "8" shaped coil, and the stimulation site is the cerebellar vermis (ie, 1 cm below the occipital bulge), and the stimulation intensity is 100% of the motor threshold.The base frequency of the iTBS mode is 5 Hz, and one short burst stimulus occurs every 200 milliseconds.
In each short array, three single pulses with a frequency of 50 Hz are buried, and each 10 short burst stimulation intervals are 8 seconds, for a total of 200 short burst stimulations.
The total number of stimulation pulses is 600 per day.It takes 3 minutes and 20 seconds to complete one intervention.
All participants were intervened once a day for 5 times a week for 2 weeks for a total of 10 times.
|
|
Schein-Komparator: control group-shame rTMS
Participants in the control group received rTMS pseudo-stimulation intervention.
The stimulation head was inverted by 180 degrees or 90 degrees according to the model of the stimulation device to achieve pseudo-stimulation and the remaining stimulation parameters were consistent with the study group.
|
There are two types of stimulation equipment, one is the transcranial magnetic stimulator model Magpro X100 produced by Danish Medtronic, and the other is the CCY-I TMS stimulator produced by Wuhan Eride, model B9076.
The stimulating magnetic head uses an "8" shaped coil, and the stimulation site is the cerebellar vermis (ie, 1 cm below the occipital bulge), and the stimulation intensity is 100% of the motor threshold.The base frequency of the iTBS mode is 5 Hz, and one short burst stimulus occurs every 200 milliseconds.
In each short array, three single pulses with a frequency of 50 Hz are buried, and each 10 short burst stimulation intervals are 8 seconds, for a total of 200 short burst stimulations.
The total number of stimulation pulses is 600 per day.It takes 3 minutes and 20 seconds to complete one intervention.
All participants were intervened once a day for 5 times a week for 2 weeks for a total of 10 times.
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
PANSS-N
Zeitfenster: 24 weeks
|
The efficacy of negative symptoms was assessed based on the patient's score changes on the PANSS（Positive and Negative Syndrome Scale） negative symptom subscale.
PANSS is a relatively mature assessment tool commonly used in clinical research to assess the severity of schizophrenia symptoms.
It consists of a positive symptom subscale (7 items), a negative symptom subscale (7 items) and a general psychopathological symptom subscale (16 items), a total of 30 items.Each item has specific definitions and operational grading criteria.
It is divided into 7 grades according to the level of psychopathology (1~7 points).
The higher the score, the heavier the symptoms.
The total score of PANSS is 30- 210 points, the positive symptom subscale and the negative symptom subscale are 7-49 points, and the general psychopathological symptoms subscale is 16 to 112 points.
|
24 weeks
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
MCCB
Zeitfenster: 24 weeks
|
The efficacy of cognitive function was assessed based on the patient's score changes on MCCB（MATRICS Consensus Cognitive Battery）.MCCB is a set of neuropsychological tests specifically designed to assess cognitive function in schizophrenia.
The MCCB Chinese version includes 9 subtests: Train Making Test, Brief Assessment of Cognition in Schizophrenia, Hopkins Verbal Learning Test, Wechsler Working Memory, Neuropsychological Assessment Battery: Mazes, Brief visuospatial Memory Test, Categoary Fluency (Animal Naming), MSCEIT Emotional Intelligence Test, Continuous Performance Test-Identical Pairs.
After the test, the MCCB computer scoring program is used to convert the rough points of each subtest into T scores, and the overall comprehensive score is calculated by the software.
The range of each test and the overall composite score T is 0-100 points.
The lower the score, the worse the cognitive function.
|
24 weeks
|
|
HAMD-24
Zeitfenster: 24 weeks
|
The efficacy of depressive symptoms was assessed based on the patient's total score changes on HAMD(Hamilton Depression Scale).This study used the 24 version of HAMD.
Most of the items in the scale use a five-level scoring standard.
The score of each item is between 0 and 4 points, with 0 points representing no; 1 point being mild; 2 points being moderate; 3 points being severe; 4 points being extremely severe.
A small number of items use a three-level scoring standard, the score of each item is between 0 and 2 points, with 0 points representing no; 1 point being light-moderate; 2 points being severe.
The higher the score, the more severe the symptoms.
The total score of the scale ranges from 0 to 76 points.
|
24 weeks
|
Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Sponsor
Ermittler
- Studienleiter: Jun Cai, Shanghai Mental Health Center
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn (Tatsächlich)
1. Juli 2017
Primärer Abschluss (Tatsächlich)
30. September 2018
Studienabschluss (Tatsächlich)
30. September 2018
Studienanmeldedaten
Zuerst eingereicht
29. April 2019
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
4. Mai 2019
Zuerst gepostet (Tatsächlich)
7. Mai 2019
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
7. Mai 2019
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
4. Mai 2019
Zuletzt verifiziert
1. April 2019
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- JCai
Plan für individuelle Teilnehmerdaten (IPD)
Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?
NEIN
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Nein
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Nein
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .
Klinische Studien zur repetitive transcranial magnetic stimulation
-
Johns Hopkins UniversityUniversity of Texas at Austin; Baszucki Brain Research Fund; Magnus MedicalAbgeschlossen