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

Primary Purpose

Ischemic Stroke

Status

Completed

Phase

Not Applicable

Locations

Georgia

Study Type

Interventional

Intervention

ISS SPG stimulation

About this trial

This is an interventional treatment trial for Ischemic Stroke focused on measuring Ischemic Stroke, Mild Acute Ischemic Stroke, Safety, Signal of Efficacy

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Age: ≥ 18 years and ≤ 80 years
Clinical diagnosis of anterior circulation stroke
Baseline NIHSS ≥ 1 and ≤ 6 or lacunar stroke of any severity
Motor and/or sensory deficits
Ability to initiate treatment within 24 hours from stroke onset
Signed informed consent from patient him/herself or legally authorized representative if applicable.
Exclusion Criteria:
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).
Massive stroke, defined as acute parenchymal lesion with effacement of cerebral sulci in over 2/3 of the MCA territory.
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.
NIHSS level of consciousness score ≥ 2.
Inability to communicate fluently and express symptoms
Previous motor and/or sensory deficits that will eliminate the ability to identify the response to SPG stimulation
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.
Known cerebral arteriovenous malformation, cerebral aneurysm.
Seizure at onset.
Blood glucose concentration < 60 mg/dL.
Clinical suspicion of septic embolus.
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.
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).
History of SPG ablation ipsilateral to the stroke side.
Any condition in the oral cavity that prevents implantation of the INS, such as patient is intubated, orthodontics or non-hygienic condition.
Life expectancy < 1 year from causes other than stroke.
Participating in any other therapeutic investigational trial within the last 30 days.
Known sensitivity to any medications to be used during study.
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.
Subjects who, in the judgment of the investigator, are likely to be non- compliant or uncooperative during the study.

Sites / Locations

Kutaisi Referral Hospital
Rustavi Central Hospital
First University Clinic
Zugdidi Referral Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Study Population

Arm Description

The ISS is intended to deliver electrical stimulation to the nerves within the greater palatine canal and pterygopalatine fossa.

Outcomes

Primary Outcome Measures

NIHSS Assessment

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

Secondary Outcome Measures

Full Information

NCT ID

NCT03551093

First Posted

May 17, 2018

Last Updated

July 22, 2019

Sponsor

BrainsGate

1. Study Identification

Unique Protocol Identification Number

NCT03551093

Brief Title

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

Acronym

ImpACT-24M

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2019

Overall Recruitment Status

Completed

Study Start Date

April 2, 2018 (Actual)

Primary Completion Date

September 11, 2018 (Actual)

Study Completion Date

September 11, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

BrainsGate

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief Summary

Study Population: Subjects with Mild Acute Ischemic Stroke in the anterior circulation within 24 hours from onset. Study objectives: Identify the personal stimulation level for each patient based on physiological biomarkers 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: Identify the personal stimulation level for each patient based on physiological biomarkers 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: Screening (day 1) Implantation (day 1) Treatment and symptom assessment (days 1-5) Device Positioning and Removal (day 5) Discharge/Final Visit (day 7-10) Outcome Measures: Primary Outcome Measures: The difference in NIHSS between baseline and Day 7 vs. Historical Controls % of patients with improvement in stroke symptoms (motor and/or sensory deficits) during stimulation Additional Efficacy Outcome Measures: Existence of physiologic surrogates of the Personal Stimulation Level Improvement in stroke symptoms (motor and/or sensory deficits) Safety Outcome Measures: Comparative 7-day safety data between the ISS stimulation group of this study and of the ImpACT-24B study: Incidence of Serious Adverse Events Implantation Complications Stimulation-related Adverse Events 7-day mortality Neurological deterioration Symptomatic intracranial hemorrhage (sICH) Implantation Accuracy Outcome Measures: 1. % of procedures with positive indication of reaching the sphenopalatine fossa

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Ischemic Stroke

Keywords

Ischemic Stroke, Mild Acute Ischemic Stroke, Safety, Signal of Efficacy

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Model Description

This will be a multi-center, adjunctive to Standard of Care, single arm study, which includes the following steps: Screening (day 1) Implantation (day 1) Treatment and symptom assessment (days 1-5) Device Positioning and Removal (day 5) Discharge/Final Visit (day 7-10)

Masking

None (Open Label)

Allocation

N/A

Enrollment

50 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Study Population

Arm Type

Experimental

Arm Description

The ISS is intended to deliver electrical stimulation to the nerves within the greater palatine canal and pterygopalatine fossa.

Intervention Type

Device

Intervention Name(s)

ISS SPG stimulation

Intervention Description

The ISS is intended to deliver electrical stimulation to the nerves within the greater palatine canal and pterygopalatine fossa (SPG).

Primary Outcome Measure Information:

Title

NIHSS Assessment

Description

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)

Time Frame

Day 7

Title

% of patients with improvement in stroke symptoms during stimulation

Description

Time Frame

Day 2-5

Other Pre-specified Outcome Measures:

Title

Increased blood flow in Common Carotid Doppler

Description

Increased blood flow in Common Carotid Doppler (if available) during stimulation at the Personal Stimulation Level (physiologic surrogates).

Time Frame

Day 1-5

Title

Existence of unilateral lacrimation, nasal secretion, and/or facial redness

Description

Unilateral lacrimation, nasal secretion, and/or facial redness (on the stimulation side) during stimulation at the Personal Stimulation Level (physiologic surrogates).

Time Frame

Day 1-5

Title

Improvement in stroke symptoms

Description

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.

Time Frame

Day 2-5

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Age: ≥ 18 years and ≤ 80 years Clinical diagnosis of anterior circulation stroke Baseline NIHSS ≥ 1 and ≤ 6 or lacunar stroke of any severity Motor and/or sensory deficits Ability to initiate treatment within 24 hours from stroke onset Signed informed consent from patient him/herself or legally authorized representative if applicable. Exclusion Criteria: 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). Massive stroke, defined as acute parenchymal lesion with effacement of cerebral sulci in over 2/3 of the MCA territory. 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. NIHSS level of consciousness score ≥ 2. Inability to communicate fluently and express symptoms Previous motor and/or sensory deficits that will eliminate the ability to identify the response to SPG stimulation 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. Known cerebral arteriovenous malformation, cerebral aneurysm. Seizure at onset. Blood glucose concentration < 60 mg/dL. Clinical suspicion of septic embolus. 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. 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). History of SPG ablation ipsilateral to the stroke side. Any condition in the oral cavity that prevents implantation of the INS, such as patient is intubated, orthodontics or non-hygienic condition. Life expectancy < 1 year from causes other than stroke. Participating in any other therapeutic investigational trial within the last 30 days. Known sensitivity to any medications to be used during study. 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. Subjects who, in the judgment of the investigator, are likely to be non- compliant or uncooperative during the study.

Facility Information:

Facility Name

Kutaisi Referral Hospital

City

Kutaisi

ZIP/Postal Code

4600

Country

Georgia

Facility Name

Rustavi Central Hospital

City

Rustavi

ZIP/Postal Code

3700

Country

Georgia

Facility Name

First University Clinic

City

Tbilisi

ZIP/Postal Code

0141

Country

Georgia

Facility Name

Zugdidi Referral Hospital

City

Zugdidi

ZIP/Postal Code

2100

Country

Georgia

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

31739771

Citation

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.

Results Reference

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

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