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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

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

Condition or disease Intervention/treatment Phase
Ischemic Stroke Device: ISS SPG stimulation Not Applicable

Show Show detailed description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
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
Official Title: 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
Actual Study Start Date : April 2, 2018
Actual Primary Completion Date : September 11, 2018
Actual Study Completion Date : September 11, 2018

Arm Intervention/treatment
Experimental: Study Population
The ISS is intended to deliver electrical stimulation to the nerves within the greater palatine canal and pterygopalatine fossa.
Device: ISS SPG stimulation
The ISS is intended to deliver electrical stimulation to the nerves within the greater palatine canal and pterygopalatine fossa (SPG).




Primary Outcome Measures :
  1. 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)

  2. % 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).


Other Outcome Measures:
  1. 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).

  2. 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).

  3. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03551093


Locations
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Georgia
Kutaisi Referral Hospital
Kutaisi, Georgia, 4600
Rustavi Central Hospital
Rustavi, Georgia, 3700
First University Clinic
Tbilisi, Georgia, 0141
Zugdidi Referral Hospital
Zugdidi, Georgia, 2100
Sponsors and Collaborators
BrainsGate

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: BrainsGate
ClinicalTrials.gov Identifier: NCT03551093    
Other Study ID Numbers: CLP0050613
First Posted: June 11, 2018    Key Record Dates
Last Update Posted: July 24, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by BrainsGate:
Ischemic Stroke
Mild Acute Ischemic Stroke
Safety
Signal of Efficacy
Additional relevant MeSH terms:
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Stroke
Cerebral Infarction
Ischemia
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes
Brain Infarction
Brain Ischemia