Contralesionale inibitoria rTMS per il recupero della funzione del braccio dopo l'ictus (ConTRAstroke)
Piattaforma canadese per prove con stimolazione cerebrale non invasiva: rTMS contralesionale inibitoria per il recupero della funzione del braccio dopo l'ictus - Una prova di fattibilità (Canstim: ConTRA-Stroke-F)
The CanStim consensus working group (multidisciplinary team of experts in rTMS from institutions across Canada) developed consensus recommendations for a protocol to deliver rTMS as an adjunct to a standard behavioral intervention to improve functional outcomes after stroke in a national stroke rehabilitation clinical trial. The overall goal of this multi-center feasibility trial is not to demonstrate that rTMS is effective, but to demonstrate that each site can recruit the assigned number of patients within a certain period, perform the stimulation procedure in conjunction with the protocol-specified intervention, complete the therapy protocol and enter complete datasets for each patient into the CanStim database. A secondary aim is to identify potential weaknesses of the consensus protocol that may need to be modified before performing a larger scale trial testing for the efficacy of the intervention. A tertiary goal is to examine sex differences in neurophysiological recovery (motor evoked potential and arm functional movement recovery) after 15 treatment sessions of repetitive transcranial magnetic stimulation (rTMS) and to identify sex and gender-related factors that predict the post-stroke recovery.
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
Rehabilitation is critical for reducing stroke-related disability. Although intensive physiotherapy improves function after a stroke, the frequency and intensity of therapy in a standard clinical rehabilitation session is insufficient to invoke these changes. Transcranial magnetic stimulation (TMS) is a safe, non-invasive method of stimulating the human brain. Repetitive TMS (rTMS) may have the potential to enhance the brain's ability to re-learn specific functions and reduce the amount of standard therapy required to achieve certain functional gains after stroke. Although two recent multicenter studies have begun to test the benefits of applying rTMS during stroke rehabilitation, large scale clinical trials demonstrating the efficacy of rTMS for post-stroke functional motor recovery are lacking. The use of rTMS interventions in stroke rehabilitation trials has been limited by a lack of consensus regarding the optimal protocol for the clinical application of TMS in stroke populations. The Canadian Platform for Trials in Non-Invasive Brain Stimulation (CanStim) is a national platform that aims to facilitate multicenter clinical trials for non-invasive brain stimulation interventions to augment recovery from stroke. As a first step, CanStim investigators convened a multidisciplinary team of experts in rTMS from institutions across Canada to form the CanStim Consensus Working Group and develop consensus recommendations for a protocol to deliver rTMS as an adjunct to standard therapy in a national stroke rehabilitation clinical trial.
Tipo di studio
Iscrizione (Effettivo)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
-
-
Quebec
-
Montreal, Quebec, Canada, H3T 1E2
- Jewish General Hospital
-
-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
- Inclusion criteria: patients with first ischemic stroke between 2 weeks and 3 months of stroke onset, patients with both cortical and subcortical infarcts, age between 18 and 90 years, English or French as language of daily use, patients must be able to participate in a standard of care upper extremity therapy program and must be able to perform the GRASP AND should have a minimum deficit that they can improve (e.g., <= 56 on FM UE). For the cognitively impaired patients, we will not exclude those with a higher upper limb mobility function. The patients with cognitive complaints, will only be included if they have a score of <24 on the Montreal Cognitive Assessment (MoCA).
- Exclusion criteria: prior symptomatic ischemic or hemorrhagic stroke, severe comprehension deficit that may compromise informed consent or understanding of instructions, contraindications to MRI and/or TMS, neurodegenerative or psychiatric disease, epilepsy, or EEG-documented epileptic discharges, chronic renal or liver failure, life-threatening diseases limiting life expectancy to less than 6 months and auditory or visual deficits that cannot be corrected and might impair testing. We will not exclude patients with higher upper limb mobility function.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Altro
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Quadruplicare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: Active rTMS
Sub-acute stroke patients will be randomized to receive actual rTMS treatment. 1Hz rTMS will be applied over contralesional M1 at an intensity of 120% resting motor threshold once daily for 30 minutes (approximately 1800 pulses) for a total of 15 sessions. |
Patients randomized to receive actual rTMS treatment will receive 1Hz rTMS applied over contralesional M1 at an intensity of 120% resting motor threshold once daily for 30 minutes (approximately 1800 pulses) for a total of 15 sessions. |
|
Comparatore fittizio: Sham control
Sub-acute stroke patients randomized to receive sham rTMS. For sham-stimulation, the TMS coil will be placed over the inter-hemispheric fissure at the vertex and stimulation will be performed with low intensity (10% resting motor threshold). This will cause similar skin sensations as real stimulation but will not induce currents in motor relevant areas. |
For sham-stimulation, the TMS coil will be placed over the inter-hemispheric fissure at the vertex and stimulation will be performed with low intensity (10% resting motor threshold). This will cause similar skin sensations as real stimulation but will not induce currents in motor relevant areas. |
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Change in the Fugl-Meyer Upper Arm Assessment between baseline, Post Day 1 and Post Day 30
Lasso di tempo: Baseline Testing done within the first three days then at 1 and 30 days post treatment. The Fugl Meyer has a minimum score of 0 and maximum score of 66. The higher the score the better the outcome.
|
Index to assess sensorimotor impairment in stroke. |
Baseline Testing done within the first three days then at 1 and 30 days post treatment. The Fugl Meyer has a minimum score of 0 and maximum score of 66. The higher the score the better the outcome.
|
|
Change in the Action Research Arm Test between baseline, Post Day 1 and Post Day 30
Lasso di tempo: Baseline Testing done within the first three days then at 1 and 30 days post treatment. The test is scored from 0-57. The higher the score the better the outcome.
|
An evaluative measure to assess specific changes in limb function among individuals who sustained cortical damage resulting in hemiplegia. It can assess a patients ability to handle objects differing in size, weight and shape and therefore can be considered to be an arm-specific measure of activity limitation. |
Baseline Testing done within the first three days then at 1 and 30 days post treatment. The test is scored from 0-57. The higher the score the better the outcome.
|
|
Change in the Modified Rankin Scale between baseline, Post Day 1 and Post Day 30
Lasso di tempo: Baseline Testing done within the first three days then at 1 and 30 days post treatment. The scale is between 0-6. Zero being no symptoms to 6 the patient is dead. The lower the score the better the outcome.
|
It is a scale for measuring the degree of disability or dependence in the activites of daily living in individuals who have suffered a stroke. |
Baseline Testing done within the first three days then at 1 and 30 days post treatment. The scale is between 0-6. Zero being no symptoms to 6 the patient is dead. The lower the score the better the outcome.
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Change in the Canadian Occupational Performance Measure between baseline, Post Day 1 and Post Day 30
Lasso di tempo: Baseline Testing done within the first three days then at 1 and 30 days post treatment. Two scores are obtained from each participant, one for performance and one for satisfaction. Each are scored between 0-10. The higher the value the better.
|
This measure serves to identify issues of personal importance to the client and to detect changes in a client's self-perception of occupational performance over time. |
Baseline Testing done within the first three days then at 1 and 30 days post treatment. Two scores are obtained from each participant, one for performance and one for satisfaction. Each are scored between 0-10. The higher the value the better.
|
Altre misure di risultato
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Sex and Gender Questionnaire
Lasso di tempo: 2 years
|
In alignment with the feasibility endpoint for the ConTRAstroke trial, the sex and gender sub-study is the feasibility of obtaining sex and gender measures across sites and the descriptive values of both blood-based biomarkers by sex and gender identity scores (as measured by the assessment tool). |
2 years
|
Collaboratori e investigatori
Sponsor
Collaboratori
Investigatori
- Investigatore principale: ALEXANDER THIEL, MD, Phd, Jewish General Hospital
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
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 (Effettivo)
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
Parole chiave
Altri numeri di identificazione dello studio
- MP-05-2020-1891
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
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 .