Questa pagina è stata tradotta automaticamente e l'accuratezza della traduzione non è garantita. Si prega di fare riferimento al Versione inglese per un testo di partenza.

Can rTMS Enhance Somatosensory Recovery After Stroke?

4 aprile 2022 aggiornato da: VA Office of Research and Development
Stroke affects over 795,000 Americans every year and has an enormous impact on the well-being of American Veterans with 6,000 new stroke admissions every year. Many of these stroke survivors are living with disabilities that limit their everyday function. One of the major consequences of stroke is loss of sensation which manifests as inability to perceive touch, temperature, pain or limb movement. Lack of sensation hinders full functional recovery. Current treatments for sensory loss produce only limited improvements and do not achieve full recovery. Therefore, it is critical to develop new therapies to re-train sensory function. The investigators propose to evaluate a novel non-invasive brain stimulation treatment called repetitive Transcranial Magnetic Stimulation (rTMS). The effects of this technique on motor deficits following stroke have been studied, however rTMS for the treatment of sensory loss has not been examined to date. The investigators' study will examine for the first time if rTMS of a sensory brain region can improve sensory function in chronic stroke survivors.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

Sensory deficits are present in the majority of stroke survivors. Inability to feel movement, touch or pain impairs the investigators' ability to interact with environment and diminished the quality of life. These sensory deficits significantly impair functional activity and slow down recovery during rehabilitation. Currently available sensory rehabilitation techniques can only partially restore sensory function. The main objective of this study is to test a novel approach to improve sensory function after stroke using non-invasive brain stimulation. This pilot study will measure an immediate effect of different repetitive Transcranial Magnetic Stimulation (rTMS) paradigms in a crossover single session design. The effect of intervention is measured with clinical measures of sensory and motor function and with neurophysiological assessment of sensory pathways. If the concept is demonstrated in this pilot study, then following the lead of other investigations of this type, this pilot will provide the foundation to test the efficacy of a long-term multi-session intervention of combined rTMS and peripherally directed therapy.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

20

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • Stati Uniti
    • Ohio
      • Cleveland, Ohio, Stati Uniti, 44106
        • Louis Stokes VA Medical Center, Cleveland, OH

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

18 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

Inclusion Criteria:

  • Medically stable at least 6 months after first ever stroke.
  • Sufficient endurance to participate in the study.
  • Cognition sufficiently intact to give valid informed consent to participate.
  • Age > 18years.
  • Ability to follow 2 stage commands.
  • Impaired but not absent ability to feel touch, vibration and movement of the affected arm.

Exclusion Criteria:

  • Acute or progressive cardiac, renal, respiratory, neurological disorders or malignancy.
  • Any psychiatric diagnosis or active psychological condition.
  • History of substance abuse within the last 6 months
  • More than one ischemic stroke or stroke affecting both sides.
  • Claustrophobia, or inability to operate the MRI patient call button.
  • Pregnancy or pregnancy planning during the study period.
  • Lower motor neuron damage or radiculopathy
  • Contraindications for rTMS according to the TMS-use guidelines (Rossi et al 2009).
  • Inability to understand English.
  • Significant neglect for those with left-sided deficits.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione incrociata
  • Mascheramento: Doppio

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Altro: High frequency rTMS
Each subject is provided with three different brain stimulation interventions in a single arm, single session crossover design study. One of the sessions was 5 Hz rTMS
Altro: repetitive transcranial magnetic stimulation (rTMS)

3 types of interventions on different sessions

  • session 1 - High frequency rTMS targeting contralesional sensory cortex
  • session 2 - Low frequency rTMS
  • session 3 - sham rTMS
Altro: peripheral sensory stimulation
peripheral sensory electrical stimulation and vibration of the stroke-affected hand administered concurrently with each rTMS
Altro: Low frequency rTMS
Each subject is provided with three different brain stimulation interventions in a single arm, single session crossover design study. One of the sessions was 1 Hz rTMS
Altro: repetitive transcranial magnetic stimulation (rTMS)

3 types of interventions on different sessions

  • session 1 - High frequency rTMS targeting contralesional sensory cortex
  • session 2 - Low frequency rTMS
  • session 3 - sham rTMS
Altro: peripheral sensory stimulation
peripheral sensory electrical stimulation and vibration of the stroke-affected hand administered concurrently with each rTMS
Altro: Sham rTMS
Each subject is provided with three different brain stimulation interventions in a single arm, single session crossover design study. One of the sessions was sham rTMS
Altro: repetitive transcranial magnetic stimulation (rTMS)

3 types of interventions on different sessions

  • session 1 - High frequency rTMS targeting contralesional sensory cortex
  • session 2 - Low frequency rTMS
  • session 3 - sham rTMS
Altro: peripheral sensory stimulation
peripheral sensory electrical stimulation and vibration of the stroke-affected hand administered concurrently with each rTMS

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change From Baseline in Two-point Discrimination
Lasso di tempo: up to 1 hour after intervention

Baseline measure is collected immediately before the intervention. There are two data collections following each intervention, one datacollection is immediately after the intervention and the second one is at 1 hour after intervention.

Two-point discrimination was measured with Disk-Criminator disks (Baltimore, MD) by determining the subjects' ability to perceive two points on the disk as two separate points rather than as a single point. The distances between the two points ranged between 2 and 15 mm. One and two sensory points were presented in a pseudo-random order to subjects' 4th digit volar fingertip surface. A threshold is determined when seventy percent accuracy is exhibited for identifying the difference between single versus double point stimulation.
up to 1 hour after intervention
Change From Baseline in N20 Somatosensory Evoked Potential(SSEP) Peak Latency
Lasso di tempo: up to 1 hour after intervention

Baseline measure is collected immediately before the intervention. Following each intervention, data is collected immediately after each intervention and at 1 hour after intervention.

SEPs were recorded with a Cadwell Sierra Wave (Cadwell, Kennewick, WA) (LSCDVAMC) or with Powerlab 4/25T (AD Instruments Inc. Colorado Springs, CO) and a Grass Stimulator (Natus Neurology, Middleton, WI) (CC)44. The recording electrodes (1 cm diameter, gold cup electrodes filled with conductive paste) were placed 2 cm posterior to C3 & C4 (10-20 international system of EEG electrode placement) and the reference electrode at Fz (Figure 1). Stimulus was applied to the median nerve at the wrist. Ground electrodes were placed at the lateral epicondyle of the stimulated arm. The evoked response from 500 stimuli were recorded and averaged for a single trial. Three SEP trials were recorded then analyzed. Latencies (in milliseconds) were determined for N20.
up to 1 hour after intervention

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

VA Office of Research and Development

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

12 aprile 2012

Completamento primario (Effettivo)

1 giugno 2019

Completamento dello studio (Effettivo)

1 aprile 2022

Date di iscrizione allo studio

Primo inviato

21 giugno 2016

Primo inviato che soddisfa i criteri di controllo qualità

21 giugno 2016

Primo Inserito (Stima)

23 giugno 2016

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

29 aprile 2022

Ultimo aggiornamento inviato che soddisfa i criteri QC

4 aprile 2022

Ultimo verificato

1 aprile 2022

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • N1767-P
  • 12025-H13 (Altro identificatore: Louis Stokes Cleveland VA Medical Center IRB)

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

prodotto fabbricato ed esportato dagli Stati Uniti

No

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 .

Prove cliniche su repetitive transcranial magnetic stimulation (rTMS)

Cerca prove simili

Sponsor e collaboratori

Condizioni mediche

Interventi farmacologici

CROs by country

CROs in South Korea

Condizioni

Malattie rare

Interventi farmacologici

Supplementi dietetici

Sponsor / Collaboratori

Sedi

Sottoscrivi