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Can rTMS Enhance Somatosensory Recovery After Stroke?

4. april 2022 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

20

Fase

  • Ikke anvendelig

Kontakter og lokationer

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Studiesteder

  • Forenede Stater
    • Ohio
      • Cleveland, Ohio, Forenede Stater, 44106
        • Louis Stokes VA Medical Center, Cleveland, OH

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Crossover opgave
  • Maskning: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Andet: 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
Andet: 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
Andet: peripheral sensory stimulation
peripheral sensory electrical stimulation and vibration of the stroke-affected hand administered concurrently with each rTMS
Andet: 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
Andet: 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
Andet: peripheral sensory stimulation
peripheral sensory electrical stimulation and vibration of the stroke-affected hand administered concurrently with each rTMS
Andet: 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
Andet: 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
Andet: peripheral sensory stimulation
peripheral sensory electrical stimulation and vibration of the stroke-affected hand administered concurrently with each rTMS

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change From Baseline in Two-point Discrimination
Tidsramme: 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
Tidsramme: 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

Samarbejdspartnere og efterforskere

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Sponsor

VA Office of Research and Development

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

12. april 2012

Primær færdiggørelse (Faktiske)

1. juni 2019

Studieafslutning (Faktiske)

1. april 2022

Datoer for studieregistrering

Først indsendt

21. juni 2016

Først indsendt, der opfyldte QC-kriterier

21. juni 2016

Først opslået (Skøn)

23. juni 2016

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

29. april 2022

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

4. april 2022

Sidst verificeret

1. april 2022

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

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

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