Clinical trial NCT03767192: Implant for Augmentation of Cerebral Blood Flow Trial, Effectiveness and Safety in a 24 Hour Window (ImpACT-24A)
Official title: 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Acute Ischemic Stroke
Keywords: acute ischemic stroke
randomized clinical trial
effectiveness
safety
Lead sponsor: BrainsGate
Sponsor class: INDUSTRY
First posted: 2018-12-06
Enrollment: 327
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Sliding Dichotomy modified Rankin Scale (mRS) at 3 months
timeFrame: 90 ±7 days
measure: Number of participants with Serious Adverse Events
timeFrame: 90 ±7 days
measure: Number of participants with neurological deterioration
timeFrame: 10 days
measure: Number of participants with implantation complications
timeFrame: 90 ±7 days
measure: Number of participants with stimulation-related adverse events
timeFrame: 90 ±7 days
measure: Mortality rate
timeFrame: 90 ±7 days
Secondary outcomes:
measure: Sliding Dichotomous 90-day mRS for patients with Aphasia at baseline
timeFrame: 90 ±7 days
measure: Binary NIHSS at Day 90
timeFrame: 90 ±7 days
measure: Stroke-related quality of life at 3 months: Stroke Impact Scale-16
timeFrame: 90 ±7 days
Other outcomes:
Locations:
city: Chattanooga
country: United States
facility: Erlanger Stroke Center
state: Tennessee
city: Erlangen
country: Germany
facility: Erlangen University Clinic
city: Essen
country: Germany
facility: Essen University Clinic
city: Heidelberg
country: Germany
facility: Heidelberg University Clinic
city: Leipzig
country: Germany
facility: Leipzig University Clinic
city: Münster
country: Germany
facility: Munster University Clinic
city: Barcelona
country: Spain
facility: Hospital Vall d'Hebron
city: Girona
country: Spain
facility: Hospital Universitari de Girona
Study officials:
affiliation: BrainsGate
name: Eyal Shay
role: STUDY_DIRECTOR
References:
citation: Bornstein NM, Saver JL, Diener HC, Gorelick PB, Shuaib A, Solberg Y, Devlin T, Leung T, Molina CA; ImpACT-24A Investigators. Sphenopalatine Ganglion Stimulation to Augment Cerebral Blood Flow: A Randomized, Sham-Controlled Trial. Stroke. 2019 Aug;50(8):2108-2117. doi: 10.1161/STROKEAHA.118.024582. Epub 2019 May 23.