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THE IMPACT- 24M TRIAL (IMPlant Augmenting Cerebral Blood Flow in Mild Strokes Trial 24 Hours From Stroke Onset) (ImpACT-24M)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03551093
Recruitment Status : Completed
First Posted : June 11, 2018
Last Update Posted : July 24, 2019
Sponsor:
Information provided by (Responsible Party):
BrainsGate

Tracking Information
First Submitted Date  ICMJE May 17, 2018
First Posted Date  ICMJE June 11, 2018
Last Update Posted Date July 24, 2019
Actual Study Start Date  ICMJE April 2, 2018
Actual Primary Completion Date September 11, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 22, 2019)
  • NIHSS Assessment [ Time Frame: Day 7 ]
    The difference in NIHSS between baseline and Day 7 vs. Historical Controls (the historical controls are patients in the control arm in the NINDS trial)
  • % of patients with improvement in stroke symptoms during stimulation [ Time Frame: Day 2-5 ]
    Assessment of improvement in stroke symptoms (motor and/or sensory deficits) before and during stimulation at the Personal Stimulation Level, using a hand dynamometer (Baseline Hydraulic Hand Dynamometers, Fabrication Enterprises Inc, White Plains NY, USA).
Original Primary Outcome Measures  ICMJE
 (submitted: May 27, 2018)
  • NIHSS Assesment [ Time Frame: Day 7 ]
    The difference in NIHSS between baseline and Day 7 vs. Historical Controls (the historical controls are patients in the control arm in the NINDS trial)
  • % of patients with improvement in stroke symptoms during stimulation [ Time Frame: Day 2-5 ]
    Assessment of improvement in stroke symptoms (motor and/or sensory deficits) before and during stimulation at the Personal Stimulation Level, using the Fugl-Meyer approach. The investigator will identify the specific deficits of the individual patient and will evaluate changes in these deficits pre and post stimulation.
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures
 (submitted: July 22, 2019)
  • Increased blood flow in Common Carotid Doppler [ Time Frame: Day 1-5 ]
    Increased blood flow in Common Carotid Doppler (if available) during stimulation at the Personal Stimulation Level (physiologic surrogates).
  • Existence of unilateral lacrimation, nasal secretion, and/or facial redness [ Time Frame: Day 1-5 ]
    Unilateral lacrimation, nasal secretion, and/or facial redness (on the stimulation side) during stimulation at the Personal Stimulation Level (physiologic surrogates).
  • Improvement in stroke symptoms [ Time Frame: Day 2-5 ]
    Assessment of improvement in stroke symptoms (motor and/or sensory deficits) before and during stimulation at the Personal Stimulation Level, using a hand dynamometer (Baseline Hydraulic Hand Dynamometers, Fabrication Enterprises Inc, White Plains NY, USA). The investigator will measure the grasp force and pincer force before and during stimulation in the affected and non-affected sides.
Original Other Pre-specified Outcome Measures
 (submitted: May 27, 2018)
  • Existence of physiologic surrogates of the Personal Stimulation Level [ Time Frame: Day 1-5 ]
    Physiologic surrogates of the Personal Stimulation Level (at least one of the 3-6 Other Pre-specified Outcomes): Increased blood flow in Common Carotid Doppler (if available)
  • Existence of physiologic surrogates of the Personal Stimulation Level [ Time Frame: Day 1-5 ]
    Physiologic surrogates of the Personal Stimulation Level (at least one of the 3-6 Other Pre-specified Outcomes): Unilateral lacrimation, nasal secretion, and/or facial redness (on the stimulation side)
  • Existence of physiologic surrogates of the Personal Stimulation Level [ Time Frame: Day 1-5 ]
    Physiologic surrogates of the Personal Stimulation Level (at least one of the 3-6 Other Pre-specified Outcomes): Changes in heart rate and blood pressure
  • Existence of physiologic surrogates of the Personal Stimulation Level [ Time Frame: Day 1-5 ]
    Physiologic surrogates of the Personal Stimulation Level (at least one of the 3-6 Other Pre-specified Outcomes): Other signs based on patient feedback
  • Improvement in stroke symptoms [ Time Frame: Day 2-5 ]
    Assessment of improvement in stroke symptoms (motor and/or sensory deficits) before and during stimulation at the Personal Stimulation Level, using the Fugl-Meyer approach. The investigator will identify the specific deficits of the individual patient and will evaluate changes in these deficits pre and post stimulation.
 
Descriptive Information
Brief Title  ICMJE THE IMPACT- 24M TRIAL (IMPlant Augmenting Cerebral Blood Flow in Mild Strokes Trial 24 Hours From Stroke Onset)
Official Title  ICMJE A Multicenter, Single Arm Trial to Assess Safety and Signal of Efficacy of the Ischemic Stroke System (ISS), as an Adjunct to Standard of Care in Subjects With Mild Acute Ischemic Stroke
Brief Summary

Study Population:

Subjects with Mild Acute Ischemic Stroke in the anterior circulation within 24 hours from onset.

Study objectives:

  1. Identify the personal stimulation level for each patient based on physiological biomarkers
  2. Identify improvement in stroke symptoms during ISS treatment at the personal stimulation level
Detailed Description

A Multicenter, Single Arm Trial to Assess Safety and Signal of Efficacy of the Ischemic Stroke System (ISS), as an Adjunct to Standard of Care in Subjects with Mild Acute Ischemic Stroke

Study Duration:

The expected total duration of the study for each subject is up to 10 days as follows:

Enrollment: up to 24 hours Treatment: Implantation, 5 Days of SPG stimulation and Standard of care Final Visit: 7 days after enrollment

Study Population:

Subjects with Mild Acute Ischemic Stroke in the anterior circulation within 24 hours from onset.

Study Objectives:

  1. Identify the personal stimulation level for each patient based on physiological biomarkers
  2. Identify improvement in stroke symptoms during ISS treatment at the personal stimulation level

Study Design:

This will be a multi-center, adjunctive to Standard of Care, single arm study, which includes the following steps:

  1. Screening (day 1)
  2. Implantation (day 1)
  3. Treatment and symptom assessment (days 1-5)
  4. Device Positioning and Removal (day 5)
  5. Discharge/Final Visit (day 7-10)

Outcome Measures:

Primary Outcome Measures:

  1. The difference in NIHSS between baseline and Day 7 vs. Historical Controls
  2. % of patients with improvement in stroke symptoms (motor and/or sensory deficits) during stimulation

Additional Efficacy Outcome Measures:

  1. Existence of physiologic surrogates of the Personal Stimulation Level
  2. Improvement in stroke symptoms (motor and/or sensory deficits)

Safety Outcome Measures:

  1. Comparative 7-day safety data between the ISS stimulation group of this study and of the ImpACT-24B study:

    1. Incidence of Serious Adverse Events
    2. Implantation Complications
    3. Stimulation-related Adverse Events
  2. 7-day mortality
  3. Neurological deterioration
  4. Symptomatic intracranial hemorrhage (sICH)

Implantation Accuracy Outcome Measures:

1. % of procedures with positive indication of reaching the sphenopalatine fossa

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Intervention Model Description:

This will be a multi-center, adjunctive to Standard of Care, single arm study, which includes the following steps:

  1. Screening (day 1)
  2. Implantation (day 1)
  3. Treatment and symptom assessment (days 1-5)
  4. Device Positioning and Removal (day 5)
  5. Discharge/Final Visit (day 7-10)
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Ischemic Stroke
Intervention  ICMJE Device: ISS SPG stimulation
The ISS is intended to deliver electrical stimulation to the nerves within the greater palatine canal and pterygopalatine fossa (SPG).
Study Arms  ICMJE Experimental: Study Population
The ISS is intended to deliver electrical stimulation to the nerves within the greater palatine canal and pterygopalatine fossa.
Intervention: Device: ISS SPG stimulation
Publications * Saver JL, Kharaishvili N, Janelidze T, Beridze M, Zarqua N, Solberg Y, Bornstein NM; IMPACT-24M Trial Investigators. Refined Sphenopalatine Ganglion Stimulator Placement and Intensity Setting to Augment Blood Flow and Neurologic Function. Stroke. 2019 Dec;50(12):3512-3518. doi: 10.1161/STROKEAHA.119.027177. Epub 2019 Nov 19.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 3, 2019)
50
Original Estimated Enrollment  ICMJE
 (submitted: May 27, 2018)
100
Actual Study Completion Date  ICMJE September 11, 2018
Actual Primary Completion Date September 11, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Age: ≥ 18 years and ≤ 80 years
  2. Clinical diagnosis of anterior circulation stroke
  3. Baseline NIHSS ≥ 1 and ≤ 6 or lacunar stroke of any severity
  4. Motor and/or sensory deficits
  5. Ability to initiate treatment within 24 hours from stroke onset
  6. Signed informed consent from patient him/herself or legally authorized representative if applicable.

    Exclusion Criteria:

  7. Neuro-imaging evidence of any intracranial hemorrhage or hemorrhagic transformation of brain infarct or other significant abnormality (e.g. tumor, abscess, suspect for subarachnoid hemorrhage).
  8. Massive stroke, defined as acute parenchymal lesion with effacement of cerebral sulci in over 2/3 of the MCA territory.
  9. Clinical signs and symptoms or evidence for a relevant lesion by neuro-imaging of an acute ischemic stroke in the posterior circulation (Vertebral, Basilar and/or Posterior Cerebral Artery territories), including but not limited to brain-stem findings and/or cerebellar findings and/or isolated homonymous hemianopia or cortical blindness.
  10. NIHSS level of consciousness score ≥ 2.
  11. Inability to communicate fluently and express symptoms
  12. Previous motor and/or sensory deficits that will eliminate the ability to identify the response to SPG stimulation
  13. Patients with bleeding propensity and/or one of the following: INR > 1.8, prolonged activated partial thromboplastin time (aPTT) ≥ 45 sec., platelets count < 75×109/L.
  14. Known cerebral arteriovenous malformation, cerebral aneurysm.
  15. Seizure at onset.
  16. Blood glucose concentration < 60 mg/dL.
  17. Clinical suspicion of septic embolus.
  18. Uncontrolled hypertension (systolic >185 mmHg and/or diastolic >110 mmHg), demonstrated on each of three repeated measurements taken within one hour regardless of whether or not the patient is taking antihypertensive medications.
  19. Serious systemic infection.
  20. Women known to be pregnant or having a positive or indeterminate pregnancy test.
  21. Patients with other implanted neural stimulator/ electronic devices (pacemakers).
  22. History of SPG ablation ipsilateral to the stroke side.
  23. Any condition in the oral cavity that prevents implantation of the INS, such as patient is intubated, orthodontics or non-hygienic condition.
  24. Life expectancy < 1 year from causes other than stroke.
  25. Participating in any other therapeutic investigational trial within the last 30 days.
  26. Known sensitivity to any medications to be used during study.
  27. Subjects who have a clinically significant or unstable medical or surgical condition that may preclude safe and complete study participation. Conditions may include: cardiovascular, vascular, pulmonary, hepatic, renal or neurological (other than acute ischemic stroke), or neoplastic diseases, as determined by medical history, physical examination, laboratory tests, or ECG.
  28. Subjects who, in the judgment of the investigator, are likely to be non- compliant or uncooperative during the study.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Georgia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03551093
Other Study ID Numbers  ICMJE CLP0050613
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party BrainsGate
Study Sponsor  ICMJE BrainsGate
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account BrainsGate
Verification Date April 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP