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

NCT ID: NCT03767192

Last Updated: 2019-01-28

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 327 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-01-31
• Study Completion Date: 2012-03-31

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.

Conditions

Acute Ischemic Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Active Stimulation

Device: The Ischemic Stroke System SPG stimulation and standard of care

Group Type: EXPERIMENTAL

Active Stimulation

Intervention Type: DEVICE

SPG stimulation and standard of care

Sham Stimulation

Device: Sham control Sham stimulation and standard of care

Group Type: SHAM_COMPARATOR

Sham Stimulation

Intervention Type: DEVICE

Sham SPG stimulation and standard of care

Interventions

Active Stimulation

SPG stimulation and standard of care

Intervention Type: DEVICE

Sham Stimulation

Sham SPG stimulation and standard of care

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

BrainsGate

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Eyal Shay

Role: STUDY_DIRECTOR

BrainsGate

Locations

Erlanger Stroke Center

Chattanooga, Tennessee, United States

Erlangen University Clinic

Erlangen, , Germany

Essen University Clinic

Essen, , Germany

Heidelberg University Clinic

Heidelberg, , Germany

Leipzig University Clinic

Leipzig, , Germany

Munster University Clinic

Münster, , Germany

Hospital Vall d'Hebron

Barcelona, , Spain

Hospital Universitari de Girona

Girona, , Spain

Countries

United States; Germany; Spain

References

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.

Reference Type: DERIVED

PMID: 31117920 (View on PubMed)

Other Identifiers

CLP1000500-24A

Identifier Type: -

Identifier Source: org_study_id