Trial Outcomes & Findings for Safety of Rt-PA + Transcranial Emission of Low-Energy Lasers for Acute Stroke Recovery (NCT NCT01220739)
NCT ID: NCT01220739
Last Updated: 2016-12-05
Results Overview
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
12 participants
Primary outcome timeframe
36 hours from tPA initiation
Results posted on
2016-12-05
Participant Flow
Participant milestones
| Measure |
Sham Transcranial Laser Therapy
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.
Transcranial Laser Therapy: 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.
|
Transcranial Laser Therapy
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.
Transcranial Laser Therapy: 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.
|
|---|---|---|
|
Overall Study
STARTED
|
7
|
5
|
|
Overall Study
COMPLETED
|
7
|
5
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Safety of Rt-PA + Transcranial Emission of Low-Energy Lasers for Acute Stroke Recovery
Baseline characteristics by cohort
| Measure |
Sham Transcranial Laser Therapy
n=7 Participants
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.
Transcranial Laser Therapy: 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.
|
Transcranial Laser Therapy
n=5 Participants
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.
Transcranial Laser Therapy: 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.
|
Total
n=12 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
64.1 years
STANDARD_DEVIATION 8.5 • n=5 Participants
|
66.8 years
STANDARD_DEVIATION 12.7 • n=7 Participants
|
65.2 years
STANDARD_DEVIATION 10.0 • n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Randomization NIH Stroke Scale
|
12.3 score on a scale
STANDARD_DEVIATION 3.2 • n=5 Participants
|
15.0 score on a scale
STANDARD_DEVIATION 2.4 • n=7 Participants
|
13.4 score on a scale
STANDARD_DEVIATION 3.1 • n=5 Participants
|
|
Post-tPA Baseline/Treatment NIH Stroke Scale
|
8.7 score on a scale
STANDARD_DEVIATION 5.4 • n=5 Participants
|
9.6 score on a scale
STANDARD_DEVIATION 5.4 • n=7 Participants
|
9.1 score on a scale
STANDARD_DEVIATION 5.2 • n=5 Participants
|
PRIMARY outcome
Timeframe: 36 hours from tPA initiationOutcome measures
| Measure |
Sham Transcranial Laser Therapy
n=7 Participants
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.
Transcranial Laser Therapy: 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.
|
Transcranial Laser Therapy
n=5 Participants
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.
Transcranial Laser Therapy: 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.
|
|---|---|---|
|
Symptomatic Intracranial Hemorrhages
|
0 participants
|
0 participants
|
PRIMARY outcome
Timeframe: 90 Days from Stroke OnsetMeasures the degree of disability or dependence in the daily activities. Minimum score = 0 (best outcome - No symptoms); Maximum Score = 6 (worse outcome - dead)
Outcome measures
| Measure |
Sham Transcranial Laser Therapy
n=7 Participants
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.
Transcranial Laser Therapy: 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.
|
Transcranial Laser Therapy
n=5 Participants
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.
Transcranial Laser Therapy: 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.
|
|---|---|---|
|
Percentage of Participants With Modified Rankin Scale (0 - 1)
|
42.9 percentage of participants
|
40.0 percentage of participants
|
Adverse Events
Sham Transcranial Laser Therapy
Serious events: 3 serious events
Other events: 6 other events
Deaths: 0 deaths
Transcranial Laser Therapy
Serious events: 2 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Sham Transcranial Laser Therapy
n=7 participants at risk
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.
Transcranial Laser Therapy: 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.
|
Transcranial Laser Therapy
n=5 participants at risk
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.
Transcranial Laser Therapy: 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.
|
|---|---|---|
|
Vascular disorders
Hypotension
|
14.3%
1/7 • Number of events 1
|
0.00%
0/5
|
|
Renal and urinary disorders
Renal failure acute
|
0.00%
0/7
|
20.0%
1/5 • Number of events 1
|
|
Nervous system disorders
Neurological symptom
|
14.3%
1/7 • Number of events 1
|
20.0%
1/5 • Number of events 1
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/7
|
20.0%
1/5 • Number of events 1
|
|
Gastrointestinal disorders
Clostridium colitis
|
14.3%
1/7 • Number of events 1
|
0.00%
0/5
|
|
Infections and infestations
Sepsis
|
14.3%
1/7 • Number of events 1
|
0.00%
0/5
|
Other adverse events
| Measure |
Sham Transcranial Laser Therapy
n=7 participants at risk
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.
Transcranial Laser Therapy: 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.
|
Transcranial Laser Therapy
n=5 participants at risk
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.
Transcranial Laser Therapy: 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.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/7
|
40.0%
2/5 • Number of events 2
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/7
|
20.0%
1/5 • Number of events 1
|
|
Endocrine disorders
Diabetes mellitus
|
0.00%
0/7
|
20.0%
1/5 • Number of events 1
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/7
|
20.0%
1/5 • Number of events 1
|
|
Eye disorders
Dry eye
|
0.00%
0/7
|
20.0%
1/5 • Number of events 1
|
|
Gastrointestinal disorders
Consitpation
|
0.00%
0/7
|
40.0%
2/5 • Number of events 2
|
|
Gastrointestinal disorders
Diarrhoea
|
14.3%
1/7 • Number of events 1
|
20.0%
1/5 • Number of events 1
|
|
Gastrointestinal disorders
Dysphagia
|
14.3%
1/7 • Number of events 1
|
40.0%
2/5 • Number of events 2
|
|
Gastrointestinal disorders
Nausea
|
14.3%
1/7 • Number of events 1
|
20.0%
1/5 • Number of events 1
|
|
Gastrointestinal disorders
Toothache
|
14.3%
1/7 • Number of events 1
|
0.00%
0/5
|
|
Gastrointestinal disorders
Vomiting
|
14.3%
1/7 • Number of events 1
|
0.00%
0/5
|
|
General disorders
Pyrexia
|
0.00%
0/7
|
20.0%
1/5 • Number of events 1
|
|
Infections and infestations
Oral candidiasis
|
14.3%
1/7 • Number of events 1
|
20.0%
1/5 • Number of events 1
|
|
Injury, poisoning and procedural complications
Renal Injury
|
14.3%
1/7 • Number of events 1
|
0.00%
0/5
|
|
Investigations
Blood potassium decreased
|
28.6%
2/7 • Number of events 2
|
0.00%
0/5
|
|
Investigations
Blood sodium increased
|
0.00%
0/7
|
20.0%
1/5 • Number of events 1
|
|
Investigations
Ubiquinone decreased
|
0.00%
0/7
|
20.0%
1/5 • Number of events 1
|
|
Metabolism and nutrition disorders
Dehydration
|
14.3%
1/7 • Number of events 1
|
0.00%
0/5
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
0.00%
0/7
|
40.0%
2/5 • Number of events 2
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/7
|
20.0%
1/5 • Number of events 1
|
|
Metabolism and nutrition disorders
Malnutrtion
|
0.00%
0/7
|
20.0%
1/5 • Number of events 1
|
|
Metabolism and nutrition disorders
Vitamin B complex deficiency
|
0.00%
0/7
|
20.0%
1/5 • Number of events 1
|
|
Metabolism and nutrition disorders
Vitamin D deficiency
|
0.00%
0/7
|
20.0%
1/5 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/7
|
20.0%
1/5 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
14.3%
1/7 • Number of events 1
|
0.00%
0/5
|
|
Nervous system disorders
Carotid artery stenosis
|
14.3%
1/7 • Number of events 1
|
0.00%
0/5
|
|
Nervous system disorders
Dementia
|
0.00%
0/7
|
20.0%
1/5 • Number of events 1
|
|
Nervous system disorders
Drooling
|
0.00%
0/7
|
20.0%
1/5 • Number of events 1
|
|
Nervous system disorders
Headache
|
28.6%
2/7 • Number of events 2
|
0.00%
0/5
|
|
Nervous system disorders
Insomnia
|
0.00%
0/7
|
20.0%
1/5 • Number of events 1
|
|
Nervous system disorders
Neurogenic bladder
|
0.00%
0/7
|
20.0%
1/5 • Number of events 1
|
|
Psychiatric disorders
Agitation
|
0.00%
0/7
|
20.0%
1/5 • Number of events 1
|
|
Psychiatric disorders
Depression
|
0.00%
0/7
|
20.0%
1/5 • Number of events 1
|
|
Psychiatric disorders
Mental status changes
|
14.3%
1/7 • Number of events 1
|
0.00%
0/5
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/7
|
20.0%
1/5 • Number of events 1
|
|
Renal and urinary disorders
Urinary Tract Infection
|
14.3%
1/7 • Number of events 1
|
40.0%
2/5 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
0.00%
0/7
|
20.0%
1/5 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnoea syndrome
|
0.00%
0/7
|
20.0%
1/5 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/7
|
20.0%
1/5 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Rash
|
14.3%
1/7 • Number of events 1
|
0.00%
0/5
|
|
Skin and subcutaneous tissue disorders
Skin burning sensation
|
0.00%
0/7
|
20.0%
1/5 • Number of events 1
|
|
Vascular disorders
Carotid artery stenosis
|
0.00%
0/7
|
40.0%
2/5 • Number of events 2
|
|
Vascular disorders
Deep vein thrombosis
|
14.3%
1/7 • Number of events 1
|
20.0%
1/5 • Number of events 2
|
|
Vascular disorders
Thrombophlebitis superficial
|
0.00%
0/7
|
20.0%
1/5 • Number of events 1
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place