Efficacy of Transcranial Magnetic Stimulation (TMS) in Central Post Stroke Pain ( CPSP)
22 oktober 2018 uppdaterad av: Juhani Ojala, Helsinki University Central Hospital
Efficacy of Navigated Repetitive Transcranial Magnetic Stimulation in Treatment of Central Post Stroke Pain
The aim of the study is to evaluate the analgesic effects of navigated repetitive transcranial magnetic stimulation in central post stroke pain.
MRI based navigation is used to determine the exact locations for stimulation.
Studieöversikt
Status
Avslutad
Betingelser
Detaljerad beskrivning
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.
Studietyp
Interventionell
Inskrivning (Faktisk)
21
Fas
- Inte tillämpbar
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år och äldre (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
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
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Crossover tilldelning
- Maskning: Trippel
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: 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.
Andra namn:
|
|
Experimentell: 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
Andra namn:
|
|
Sham Comparator: 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.
Andra namn:
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Change in average pain compared to baseline
Tidsram: 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
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Quality of life (EQ-5D)
Tidsram: 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
Tidsram: 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
Tidsram: 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)
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Utredare
- Huvudutredare: 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
- Studiestol: Jyrki Mäkelä, MD, PhD, Head of laboratory, BioMag, Helsinki University Central Hospital
- Studiestol: Erika Kirveskari, MD, PhD, Head and Chief Physician of Clinical Neurophysiology at Medical Imaging Center, Helsinki University Hospital
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 maj 2013
Primärt slutförande (Faktisk)
1 maj 2016
Avslutad studie (Faktisk)
1 september 2016
Studieregistreringsdatum
Först inskickad
22 oktober 2014
Först inskickad som uppfyllde QC-kriterierna
27 oktober 2014
Första postat (Uppskatta)
29 oktober 2014
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
24 oktober 2018
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
22 oktober 2018
Senast verifierad
1 oktober 2018
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- TYH2013311
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
NEJ
IPD-planbeskrivning
That is not allowed according to the ethical committees decision.
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