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

NCT03767192 | Terminated DMC FDA Device

• 1 other identifier: CLP1000500-24A
• Study Type: interventional
• Target: 327
• Locations: 3 countries
• Sites: 8

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.

Conditions

Acute Ischemic Stroke

Keywords

acute ischemic stroke; randomized clinical trial; effectiveness; safety

Outcome Measures

Primary Outcomes (6)

• 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.

  90 ±7 days

• Number of participants with Serious Adverse Events

  Comparison between the active and sham stimulation groups of all serious adverse events (SAEs)

  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

  10 days

• Number of participants with implantation complications

  The rate of implantation complications as classified by the investigator

  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

  90 ±7 days

• Mortality rate

  Comparison of mortality rates between the active and sham stimulation groups

  90 ±7 days

Secondary Outcomes (3)

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

  90 ±7 days

• Binary NIHSS at Day 90

  90 ±7 days

• Stroke-related quality of life at 3 months: Stroke Impact Scale-16

  90 ±7 days

Study Arms (2)

Active Stimulation

EXPERIMENTAL

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

Device: Active Stimulation

Sham Stimulation

SHAM COMPARATOR

Device: Sham control Sham stimulation and standard of care

Device: Sham Stimulation

Interventions

Active Stimulation DEVICE

SPG stimulation and standard of care

Active Stimulation

Sham Stimulation DEVICE

Sham SPG stimulation and standard of care

Sham Stimulation

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• BrainsGate: lead

Study Sites (8)

Erlanger Stroke Center

Chattanooga, Tennessee, 37404, United States

Location

Erlangen University Clinic

Erlangen, Germany

Location

Essen University Clinic

Essen, Germany

Location

Heidelberg University Clinic

Heidelberg, Germany

Location

Leipzig University Clinic

Leipzig, Germany

Location

Munster University Clinic

Münster, Germany

Location

Hospital Vall d'Hebron

Barcelona, Spain

Location

Hospital Universitari de Girona

Girona, Spain

Location

Related Publications (1)

• 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.

  PMID: 31117920 DERIVED

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Eyal Shay

  BrainsGate

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 5, 2018
• First Posted: December 6, 2018
• Study Start: January 1, 2009
• Primary Completion: January 1, 2011
• Study Completion: March 1, 2012
• Last Updated: January 28, 2019

Record last verified: 2018-12

Locations

DE (5); US (1); ES (2)