Safety of Rt-PA + Transcranial Emission of Low-Energy Lasers for Acute Stroke Recovery

NCT01220739 | Terminated Phase 2 Results DMC

• 2 other identifiers: StELLARP50NS044148
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 3

Brief Summary

To assess the safety and preliminary efficacy of combining intravenous rt-PA with transcranial laser therapy (TLT) with the NeuroThera® Laser System (referred to hereafter as NTS) in subjects treated for acute ischemic stroke. Treatment with IV rt-PA must begin within 3 hours of symptom onset, and the initiation of TLT procedure must be feasible for each subject within 6 hours of stroke onset. The NeuroThera® Laser System is an investigational device that provides noninvasive transcranial laser therapy to subjects diagnosed with acute ischemic stroke. The wavelength of the laser light is in the infrared zone of the electromagnetic spectrum and is invisible to the naked eye.

Conditions

Ischemic Stroke

Keywords

ischemic stroke; transcranial laser; tissue plasminogen activator; therapy

Outcome Measures

Primary Outcomes (2)

• Symptomatic Intracranial Hemorrhages

  36 hours from tPA initiation

• Percentage of Participants With Modified Rankin Scale (0 - 1)

  Measures the degree of disability or dependence in the daily activities. Minimum score = 0 (best outcome - No symptoms); Maximum Score = 6 (worse outcome - dead)

  90 Days from Stroke Onset

Study Arms (2)

IV tPA + Sham Transcranial Laser Therapy

SHAM COMPARATOR

Subjects in this treatment arm will receive IV tPA within 3 hours of stroke symptom onset followed by sham transcranial laser therapy no sooner than 12 hours after tPA and no greater than 24 hours from stroke onset.

Device: Transcranial Laser Therapy

IV tPA +Transcranial Laser Therapy

ACTIVE COMPARATOR

Subjects in this treatment arm will receive IV tPA within 3 hours of stroke symptom onset followed by transcranial laser therapy no sooner than 12 hours after tPA and no greater than 24 hours from stroke onset.

Device: Transcranial Laser Therapy

Interventions

Transcranial Laser Therapy DEVICE

Transcranial laser therapy is administered with the NeuroThera® Laser System (NTS) in subjects diagnosed with acute ischemic stroke. A laser system is a medical instrument that concentrates energy light on an area. Laser treatment has been used to deliver intense light energy to aid in the healing of tissues and wounds. The transcranial laser treatment procedure consists of applying the NTS laser to twenty different sites on the skull for two minutes at each site.

Also known as: TLT, NeuroThera Laser System (NTS)

IV tPA + Sham Transcranial Laser Therapy; IV tPA +Transcranial Laser Therapy

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects may be included in the study only if they meet all of the following criteria:
• Subject is at least 40 years of age at screening, but has not had their 81st birthday.
• Subject has received IV rt-PA per the NINDS rt-PA Protocol Guidelines within 3 hours of symptom onset for an acute ischemic stroke.
• Subject is diagnosed with acute ischemic stroke and presents to the health care facility at a time such that initiation of NTS procedure is feasible within 6 hours of the time of stroke onset. The time of stroke onset is defined as the time at which a change in the baseline neurological function occurred. If the time is not known (e.g., the subject awakens from sleep with new symptoms), the last time the patient was observed to be neurologically intact must be considered to be the time of onset.
• Documented baseline NIHSS score of \> 7 and \< 17 prior to IV rt-PA administration. Subjects who transfer from other facilities after receiving IV rt-PA must have a documented NIHSS by a certified examiner prior to initiation of rt-PA treatment. Documentation of NIHSS score via telemedicine is acceptable if performed by a certified examiner. Subjects who improve prior to NTS procedure will still be treated, unless their NIHSS improves to 0.
• Full functional independence just prior to the present stroke episode as defined by the following criteria:
• Estimated prestroke mRS score 0 or 1.
• Ambulates independently, may need a cane or walker, but does not need the assistance of another person.
• Absence of a medical/physical/mental condition that substantially limits the subject's ability to work, study, participate in leisure activities, or look after family at home
• Completely independent, does not need supervision (may live with other individuals, but could live alone if necessary)
• Negative serum or urine pregnancy test in females of childbearing potential.
• Subject (or legally authorized representative) provides written Informed Consent in compliance with local regulations prior to enrollment into this study.
• The subject (and caregiver, if applicable) is willing to participate in this study for at least 90 days after the onset of stroke.-

You may not qualify if:

• Evidence on from a pre-tPA head CT of an intracranial, subdural, or subarachnoid hemorrhage or clinical presentation suggestive of subarachnoid hemorrhage even if the initial neuroimaging scan is normal.
• Clinical presentation consistent with a brainstem or cerebellar stroke
• A rapidly improving neurological status that in the opinion of the investigator will make the subject unsuitable for participation in this study or patient rapidly improves to NIHSS of 0 by start of NTS procedure.
• The subject had a seizure at stroke onset or within the 7 days prior to stroke onset.
• Sustained blood glucose \> 300 mg/dl or \< 60 mg/dl
• Subjects who, on repeated measurement, have a systolic blood pressure \> 185, or a diastolic blood pressure \> 110mmHg, post rt-PA administration, or it is the opinion of the investigator that aggressive treatment to reduce blood pressure post thrombolysis is required to keep pressure within these limits.
• Presumed and/or confirmed septic embolus.
• The subject has a history of CNS vascular wall disease (e.g. aneurysm, AVM).
• The subject has a history of CNS disease or damage (e.g. neoplasm or dementia) which may influence the subject's outcome assessment.
• The subject has a significant skin condition (i.e., hemangioma, scleroderma, psoriasis, rash, open wound or tattoo) on their scalp that is found to be directly below three or more TLT procedure sites.
• Planned or actual use of any intra-arterial thrombolytic medication or a clot retrieval device, or any diagnostic or therapeutic interventional neurovascular procedure, including mechanical recanalization, whether successful or unsuccessful, during this stroke episode.
• Subject previously participated in another investigational drug or device trial within the preceding four weeks.
• Subject is a female who is pregnant or lactating (within the previous 30 days),or who is of child-bearing potential unless she is surgically sterile or she and/or her partner are using a medically acceptable method of birth control.
• The subject has an implant of any kind in the head (i.e. clipped aneurysm, embolised AVM, implantable shunt - Hakim valve).
• Any use of light-activated drugs (photodynamic therapy) within 14 days prior to study enrollment.

Sponsors & Collaborators

• University of California, San Diego: lead
• National Institute of Neurological Disorders and Stroke (NINDS): collaborator

Study Sites (3)

Swedish Medical Center

Englewood, Colorado, 80113, United States

Location

Palmetto Health Richland

Columbia, South Carolina, 29203, United States

Location

Providence Medical Research Center

Spokane, Washington, 99204, United States

Location

Related Publications (3)

• Zivin JA, Albers GW, Bornstein N, Chippendale T, Dahlof B, Devlin T, Fisher M, Hacke W, Holt W, Ilic S, Kasner S, Lew R, Nash M, Perez J, Rymer M, Schellinger P, Schneider D, Schwab S, Veltkamp R, Walker M, Streeter J; NeuroThera Effectiveness and Safety Trial-2 Investigators. Effectiveness and safety of transcranial laser therapy for acute ischemic stroke. Stroke. 2009 Apr;40(4):1359-64. doi: 10.1161/STROKEAHA.109.547547. Epub 2009 Feb 20.

  PMID: 19233936 BACKGROUND

• Hacke W, Schellinger PD, Albers GW, Bornstein NM, Dahlof BL, Fulton R, Kasner SE, Shuaib A, Richieri SP, Dilly SG, Zivin J, Lees KR; NEST 3 Committees and Investigators. Transcranial laser therapy in acute stroke treatment: results of neurothera effectiveness and safety trial 3, a phase III clinical end point device trial. Stroke. 2014 Nov;45(11):3187-93. doi: 10.1161/STROKEAHA.114.005795. Epub 2014 Oct 7.

  PMID: 25293665 BACKGROUND

• Huisa BN, Stemer AB, Walker MG, Rapp K, Meyer BC, Zivin JA; NEST-1 and -2 investigators. Transcranial laser therapy for acute ischemic stroke: a pooled analysis of NEST-1 and NEST-2. Int J Stroke. 2013 Jul;8(5):315-20. doi: 10.1111/j.1747-4949.2011.00754.x. Epub 2012 Feb 2.

  PMID: 22299818 BACKGROUND

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

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

Limitations and Caveats

Study was terminated early due to device sponsor filing bankruptcy.

Results Point of Contact

• Title: Dr. Thomas Hemmen
• Organization: University of California, San Diego

themmen@ucsd.edu

858-657-7190

Study Officials

• Thomas Hemmen, MD, PhD

  University of California, San Diego

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Department of Neurosciences

Study Record Dates

• First Submitted: October 13, 2010
• First Posted: October 14, 2010
• Study Start: June 1, 2011
• Primary Completion: December 1, 2012
• Study Completion: April 1, 2013
• Last Updated: December 5, 2016
• Results First Posted: December 5, 2016

Record last verified: 2016-10

Data Sharing

• IPD Sharing: Will share

Locations

US (3)