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Implant for Augmentation of Cerebral Blood Flow Trial, Effectiveness and Safety in a 24 Hour Window (ImpACT-24A) (ImpACT-24A)

25 gennaio 2019 aggiornato da: BrainsGate

A Multicenter, Randomized, Double Blind, Sham Control, Parallel Arm Trial to Assess Effectiveness and Safety of the Ischemic Stroke System ISS, as an Adjunct to Standard of Care in Subjects With Acute Ischemic Stroke

The primary objective of the study is to assess the safety and effectiveness of SPG stimulation with the ISS in patients with an acute ischemic stroke in the anterior circulation initiated within 24 hours from stroke onset.

Panoramica dello studio

Stato

Terminato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

This study was first registered as NCT00826059 on January 19, 2009 under the name ImpACT-24.

Background:

Recruitment to ImpACT-24 was halted, the protocol was amended and then the study was resumed. Later, it was decided to define the first part (before the halt) as a separate study - ImpACT-24A, and identify the continuation of the study as ImpACT-24B. ImpACT-24B continues to be registered as NCT00826059, and ImpACT-24A is registered in this new record.

Detailed Description:

A multi-center, multinational, randomized, double blind, sham control, adjunctive to Standard of Care, parallel arm study with ongoing DSMB review of accumulated safety data.

Screening:

Treatment should be initiated between 8 and 24 hours from stroke onset. All screened patients will be identified by patient number and will sign the informed consent prior to any study procedure initiation.

Period 1: Day 1-5

Day 1- Eligible subjects will be randomized in a 2:1 (ISS Stimulation: Sham Control) ratio:

Group 1: Implantation and ISS Stimulation during five consecutive days & Standard of Care Group 2: Implantation and Sham Stimulation during five consecutive days & Standard of Care The implantation will be performed by a trained physician. Stimulation/sham stimulation will be delivered Day 2-5 ISS / Sham Stimulation will be repeated during the following four consecutive days by trained personnel within 18-26 hours from preceding stimulation.

Day 5 / Day of Discharge. Following the last ISS /Sham Stimulation, explantation will be performed.

Subjects will continue with Standard of Care as needed and will be released from the hospital upon investigator's judgment.

Period 2: Day of Discharge - 90±7 days During this period both groups (ISS Stimulation and Sham Control) will be treated according to Standard of Care either at the hospital, rehabilitation center or at home.

Scheduled visits will be performed on day 30±7 and day 60 ±7, which will include safety and effectiveness assessments.

Final Visit Day 90±7 days: The final visit will be performed at the study site and will include safety and effectiveness evaluations.

Patients will be contacted by study personnel via telephone on Day 180±7 and on Day 360±7 in order to assess their quality of life status.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

327

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

  • Germania
      • Erlangen, Germania
        • Erlangen University Clinic
      • Essen, Germania
        • Essen University Clinic
      • Heidelberg, Germania
        • Heidelberg University Clinic
      • Leipzig, Germania
        • Leipzig University Clinic
      • Münster, Germania
        • Munster University Clinic
  • Spagna
      • Barcelona, Spagna
        • Hospital Vall d'Hebron
      • Girona, Spagna
        • Hospital Universitari de Girona
  • Stati Uniti
    • Tennessee
      • Chattanooga, Tennessee, Stati Uniti, 37404
        • Erlanger Stroke Center

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

Da 18 anni a 85 anni (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

Inclusion Criteria:

  1. Age: ≥ 18 years and ≤ 85 of both genders.
  2. Clinical diagnosis of an acute ischemic stroke in the Carotid, Middle or Anterior Cerebral Artery territories
  3. Baseline NIHSS ≥ 7 and ≤ 18
  4. Ability to initiate treatment within 8- 24 hours from stroke onset.

Exclusion Criteria:

  1. Intracranial hemorrhage or hemorrhagic transformation
  2. Massive stroke
  3. Acute ischemic stroke in the posterior circulation
  4. Minor stroke
  5. Treated with IV-tPA ,IA-tPA or neurothrombectomy devices for the current stroke
  6. Previous stroke in the last 6 months or pre-existing disability
  7. Patients with bleeding propensity or any condition in the oral cavity that prevents implantation
  8. Known cerebral arteriovenous malformation, cerebral aneurysm.
  9. Clinical suspicion of septic embolus.
  10. Uncontrolled hypertension (systolic >185 mmHg and/or diastolic >110 mmHg)
  11. Serious systemic infection.
  12. Women known to be pregnant or having a positive or indeterminate pregnancy test.
  13. Patients with other implanted neural stimulator/ electronic devices (pacemakers).
  14. Life expectancy < 1 year from causes other than stroke.

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 parallela
  • Mascheramento: Quadruplicare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Active Stimulation
Device: The Ischemic Stroke System SPG stimulation and standard of care
Dispositivo: Active Stimulation
SPG stimulation and standard of care
Comparatore fittizio: Sham Stimulation
Device: Sham control Sham stimulation and standard of care
Dispositivo: Sham Stimulation
Sham SPG stimulation and standard of care

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Sliding Dichotomy modified Rankin Scale (mRS) at 3 months
Lasso di tempo: 90 ±7 days

Final global disability level on the modified Rankin scale (mRS) at 3 months better than expectation (sliding dichotomy analysis) ) assessed in the modified intention to treat (mITT) population defined as all randomized subjects receiving at least the minimal exposure of 1 treatment (ISS Stimulation or Sham Control) session out of the 5 planned sessions.

mRS Scale:

  • 0 - No symptoms.
  • 1 - No significant disability. Able to carry out all usual activities, despite some symptoms.
  • 2 - Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities.
  • 3 - Moderate disability. Requires some help, but able to walk unassisted.
  • 4 - Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted.
  • 5 - Severe disability. Requires constant nursing care and attention, bedridden, incontinent.
  • 6 - Dead.
90 ±7 days
Number of participants with Serious Adverse Events
Lasso di tempo: 90 ±7 days
Comparison between the active and sham stimulation groups of all serious adverse events (SAEs)
90 ±7 days
Number of participants with neurological deterioration
Lasso di tempo: 10 days
Comparison between the active and sham stimulation groups of the rate of neurological deterioration, defined as an increase of 4 or more points on the NIHSS related to any neurological event within the first 10 days after stroke onset
10 days
Number of participants with implantation complications
Lasso di tempo: 90 ±7 days
The rate of implantation complications as classified by the investigator
90 ±7 days
Number of participants with stimulation-related adverse events
Lasso di tempo: 90 ±7 days
Comparison between the active and sham stimulation groups of stimulation-related adverse events as classified by the investigator
90 ±7 days
Mortality rate
Lasso di tempo: 90 ±7 days
Comparison of mortality rates between the active and sham stimulation groups
90 ±7 days

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Sliding Dichotomous 90-day mRS for patients with Aphasia at baseline
Lasso di tempo: 90 ±7 days

Sliding Dichotomous 90-day mRS for patients with Aphasia at baseline

mRS Scale:

  • 0 - No symptoms.
  • 1 - No significant disability. Able to carry out all usual activities, despite some symptoms.
  • 2 - Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities.
  • 3 - Moderate disability. Requires some help, but able to walk unassisted.
  • 4 - Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted.
  • 5 - Severe disability. Requires constant nursing care and attention, bedridden, incontinent.
  • 6 - Dead.
90 ±7 days
Binary NIHSS at Day 90
Lasso di tempo: 90 ±7 days

Binary NIHSS (success for score ≤1 or for ≥ 9-point improvement versus baseline)

The NIHSS (National Institute of Health Stroke Score) is a 42-point scale that quantifies neurological deficits in 11 categories. Ratings for each item are scored with 3 to 5 grades, with 0 as normal.
90 ±7 days
Stroke-related quality of life at 3 months: Stroke Impact Scale-16
Lasso di tempo: 90 ±7 days

Stroke-related quality of life at 3 months according to the Stroke Impact Scale-16 (SIS-16)

The scale is based on a questionnaire with 16 items. Each answer ranges from 1 (poor) to 5 (good). A final single-item Recovery domain assesses the individual's perception of his/her recovery from stroke, where:

0 = no recovery 100 = full recovery.

Domain scores range from 0-100 and are calculated using the following equation:

Domain score = [(Mean item score - 1) / (5-1) ] x 100
90 ±7 days

Collaboratori e investigatori

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

Sponsor

BrainsGate

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)

1 gennaio 2009

Completamento primario (Effettivo)

1 gennaio 2011

Completamento dello studio (Effettivo)

1 marzo 2012

Date di iscrizione allo studio

Primo inviato

5 dicembre 2018

Primo inviato che soddisfa i criteri di controllo qualità

5 dicembre 2018

Primo Inserito (Effettivo)

6 dicembre 2018

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

28 gennaio 2019

Ultimo aggiornamento inviato che soddisfa i criteri QC

25 gennaio 2019

Ultimo verificato

1 dicembre 2018

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • CLP1000500-24A

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

Sì

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 .

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