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Can rTMS Enhance Somatosensory Recovery After Stroke?

4. april 2022 oppdatert av: 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.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert 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.

Studietype

Intervensjonell

Registrering (Faktiske)

20

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Forente stater
    • Ohio
      • Cleveland, Ohio, Forente stater, 44106
        • Louis Stokes VA Medical Center, Cleveland, OH

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Crossover-oppdrag
  • Masking: Dobbelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Annen: 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
Annen: 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
Annen: peripheral sensory stimulation
peripheral sensory electrical stimulation and vibration of the stroke-affected hand administered concurrently with each rTMS
Annen: 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
Annen: 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
Annen: peripheral sensory stimulation
peripheral sensory electrical stimulation and vibration of the stroke-affected hand administered concurrently with each rTMS
Annen: 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
Annen: 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
Annen: peripheral sensory stimulation
peripheral sensory electrical stimulation and vibration of the stroke-affected hand administered concurrently with each rTMS

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
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

Samarbeidspartnere og etterforskere

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Sponsor

VA Office of Research and Development

Publikasjoner og nyttige lenker

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Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

12. april 2012

Primær fullføring (Faktiske)

1. juni 2019

Studiet fullført (Faktiske)

1. april 2022

Datoer for studieregistrering

Først innsendt

21. juni 2016

Først innsendt som oppfylte QC-kriteriene

21. juni 2016

Først lagt ut (Anslag)

23. juni 2016

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

29. april 2022

Siste oppdatering sendt inn som oppfylte QC-kriteriene

4. april 2022

Sist bekreftet

1. april 2022

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

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

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

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Studerer et amerikansk FDA-regulert medikamentprodukt

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Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

produkt produsert i og eksportert fra USA

Nei

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