An interventional study of Active Stimulation and Sham Stimulation in Acute Ischemic Stroke, sponsored by BrainsGate. Terminated at 8 sites in 3 countries. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2019-01-28.
Sponsored by BrainsGate · Not applicable, Interventional, and Treatment
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.
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.
7,286 studies on the registry are indexed under Stroke; 2,007 are open to participants now.
This study's enrollment of 327 is above the median of 50 across 5,369 interventional studies indexed under Stroke.
Browse Stroke studies →BrainsGate is the lead sponsor of 7 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Device: The Ischemic Stroke System SPG stimulation and standard of care
Device: Active Stimulation
Device: Sham control Sham stimulation and standard of care
Device: Sham Stimulation
SPG stimulation and standard of care
Sham SPG stimulation and standard of care
Sliding Dichotomy modified Rankin Scale (mRS) at 3 months
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.
Time frame: 90 ±7 days
Number of participants with Serious Adverse Events
Comparison between the active and sham stimulation groups of all serious adverse events (SAEs)
Time frame: 90 ±7 days
Number of participants with neurological deterioration
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
Time frame: 10 days
Number of participants with implantation complications
The rate of implantation complications as classified by the investigator
Time frame: 90 ±7 days
Number of participants with stimulation-related adverse events
Comparison between the active and sham stimulation groups of stimulation-related adverse events as classified by the investigator
Time frame: 90 ±7 days
Mortality rate
Comparison of mortality rates between the active and sham stimulation groups
Time frame: 90 ±7 days
Sliding Dichotomous 90-day mRS for patients with Aphasia at baseline
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.
Time frame: 90 ±7 days
Binary NIHSS at Day 90
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.
Time frame: 90 ±7 days
Stroke-related quality of life at 3 months: Stroke Impact Scale-16
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
Time frame: 90 ±7 days
This study is terminated, as verified in Dec 2018. You cannot join it, but the record below documents what was studied.
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