- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT02277912
Efficacy of Transcranial Magnetic Stimulation (TMS) in Central Post Stroke Pain ( CPSP)
Efficacy of Navigated Repetitive Transcranial Magnetic Stimulation in Treatment of Central Post Stroke Pain
Panoramica dello studio
Stato
Condizioni
Descrizione dettagliata
Central post stroke pain is often very resistant to treatment. TMS has been shown to be a promising tool in treating difficult pain conditions. The best sites for stimulation are still not known and navigation has been used only in few studies.
The aim is to evaluate the analgesic effects of Navigated Repetitive Transcranial Magnetic Stimulation ( nrTMS ) on pain in a three armed crossover study. The navigation is done by using magnetic resonance imaging and stereotactic camera system. The three arms include stimulation to M1, S2 and sham stimulation to M1. 10 Hz repetitive stimulation is given to a specified location once a day 5 days a week for two weeks in each of the three arms. A months washout period is kept between each arm of the study.
Pain and other variables are followed before, during and after the study for 6 months.
Tipo di studio
Iscrizione (Effettivo)
Fase
- Non applicabile
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion Criteria:
- MRI defined brain infarction or hemorrhage before or at the age of 65 years
- CPSP diagnostic criteria is met (definite), verified by a neurologist
- Stable analgesic medication
- Average pain NRS 4 or more
Exclusion Criteria:
- Epilepsy
- Difficult aphasia
- Dementia
- Contraindication for TMS or MRI
- Alcohol and/or drug abuse
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione incrociata
- Mascheramento: Triplicare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
---|---|
Sperimentale: Transcranial Magnetic Stimulation I
Intervention: Repetitive navigated Transcranial Magnetic Stimulation of the motor cortex
|
Navigated repetitive transcranial magnetic stimulation of the motor cortex ( 10 Hz ) ,5 daily sessions per week for two weeks.
Altri nomi:
|
Sperimentale: Transcranial Magnetic Stimulation II
Intervention: Repetitive navigated Transcranial Magnetic Stimulation of the secondary somatosensory cortex
|
Navigated repetitive transcranial magnetic stimulation of the secondary somatosensory cortex ( 10 Hz ), 5 daily sessions per week for two weeks
Altri nomi:
|
Comparatore fittizio: Sham Stimulation
Intervention: Repetitive sham Transcranial Magnetic Stimulation with SHAM block of the motor cortex
|
Repetitive SHAM transcranial magnetic stimulation of the motor cortex ( 10Hz) 5 daily sessions per week for two weeks.
Altri nomi:
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Change in average pain compared to baseline
Lasso di tempo: 1 month after each arm of the study
|
Patients will keep a pain diary for one week before stimulation and for two weeks after the stimulation.
A nurse will call the patient one month after the last stimulation.
|
1 month after each arm of the study
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Quality of life (EQ-5D)
Lasso di tempo: One week after each arm of the study and 6 months after the last one
|
Questionnaire EQ-5D
|
One week after each arm of the study and 6 months after the last one
|
Depression
Lasso di tempo: One week after each arm of the study and 6 months after the last stimulation
|
Questionnaire
|
One week after each arm of the study and 6 months after the last stimulation
|
Change in average pain compared to baseline
Lasso di tempo: 2,3,4,5 and 6 months after the last stimulation
|
Phone call ( Numeric Rating Scale (NRS) in rest and movement )
|
2,3,4,5 and 6 months after the last stimulation
|
Magnetoencephalography (MEG)
Lasso di tempo: One week before and after each arms stimulations
|
Changes in the irritability of the motor cortex and somatosensory cortex
|
One week before and after each arms stimulations
|
Number of patients with adverse effects
Lasso di tempo: From the start to the end of the study, on average 12 months per patient.
|
Adverse effects are followed actively
|
From the start to the end of the study, on average 12 months per patient.
|
Hands´ motor function and dexterity
Lasso di tempo: One week before and after each arm of the study
|
Nine hole peg, Pinch and Jamar
|
One week before and after each arm of the study
|
Cold water test
Lasso di tempo: One week before and after each arm of the study
|
Conditioned pain modulation (CPM)
|
One week before and after each arm of the study
|
Genetics
Lasso di tempo: No time frame, just a blood sample
|
Evaluation of genetical properties in terms of TMS related pain reduction
|
No time frame, just a blood sample
|
Collaboratori e investigatori
Investigatori
- Investigatore principale: Eija Kalso, PhD, Prof., Professor of Pain Research and Management, University of Helsinki. Director of the Multidisciplinary Pain Clinic, Department of Anaesthesia and Intensive Care Medicine Helsinki University Central Hospital
- Cattedra di studio: Jyrki Mäkelä, MD, PhD, Head of laboratory, BioMag, Helsinki University Central Hospital
- Cattedra di studio: Erika Kirveskari, MD, PhD, Head and Chief Physician of Clinical Neurophysiology at Medical Imaging Center, Helsinki University Hospital
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- TYH2013311
Piano per i dati dei singoli partecipanti (IPD)
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Descrizione del piano IPD
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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