StrokePhase 1NCT00675155
Far Infrared Irradiation for Stroke Rehabilitation
A Phase 1 study testing Far Infrared Radiation in people with Stroke, run by GAAD Medical Research Institute Inc. at 1 site in Canada.
Trial summary
A stroke is a sudden loss of brain function. It is caused by the interruption of flow of blood to the brain (ischemic stroke) or the rupture of blood vessels in the brain (hemorrhagic stroke). This study will investigate the use of far infrared radiation for stroke rehabilitation. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Stroke
- What is being tested?
- Far Infrared Radiation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteCanada
- Study dates
- May 2008to Jun 2010
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- People with Stroke
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase 1 Study to Determine the Efficacy of Using Far Infrared Radiation for Stroke Rehabilitation
A stroke is a sudden loss of brain function. It is caused by the interruption of flow of blood to the brain (ischemic stroke) or the rupture of blood vessels in the brain (hemorrhagic stroke). This study will investigate the use of far infrared radiation for stroke rehabilitation.
Read the detailed description
A stroke is a sudden loss of brain function. The interruption of blood flow or the rupture of blood vessels causes brain cells (neurons) in the affected area to die. The effects of a stroke depend on where the brain was injured, as well as how much damage occurred. A stroke can impact any number of areas including your ability to move, see, remember, speak, reason and read and write.
It is hereby postulated that irradiation using far infrared, with wavelength between 5 to 20 microns, of the central nervous system, the endocrine system and the whole body could prevent, control, manage or possibly lead to complete rehabilitation of people with stroke.
- Conditions
- Stroke
- Being tested
- Far Infrared Radiation
- Keywords
- Apoplexy, Cerebral Stroke, Cerebrovascular Accident, Cerebrovascular Accident, Acute, Cerebrovascular Apoplexy, Cerebrovascular Stroke
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Far Infrared RadiationRadiation
Radiation: Far Infrared Radiation (5μm to 20μm wavelength) Far Infrared radiation for 30 to 40 minutes per treatment session.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Radiation: Far Infrared Radiation (5μm to 20μm wavelength) Receives: Radiation: Far Infrared Radiation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Management and Cure of Stroke
Measured: 2 Years
Secondary outcomes (1)
Rehabilitation of the following: ability to move, see, remember, speak, reason and read and write.
Measured: 2 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2008 (estimated)
- Study startMay 2008
- Primary completionMay 2010 (estimated)
- Study completionJun 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- GAAD Medical Research Institute Inc.
- Sponsor type
- University, hospital or other
- Investigators
- Ken Nedd, M.D., Principal investigator, GAAD Medical Research Institute Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00675155
- Sponsor's protocol ID
- GAAD-SR-CTP1
- Status last verified
- Jan 2009
- First submitted
- 6 May 2008
- Last updated
- 5 Jan 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1 Study to Determine the Efficacy of Using Far Infrared Radiation for Stroke Rehabilitation
- ClinicalTrials.gov ID
- NCT00675155
- Acronym / sponsor ID
- GAAD-SR-CTP1
- Conditions
- Stroke
- Keywords
- Apoplexy, Cerebral Stroke, Cerebrovascular Accident, Cerebrovascular Accident, Acute, Cerebrovascular Apoplexy, Cerebrovascular Stroke
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- GAAD Medical Research Institute Inc.University, hospital or other
- Study start
- May 2008
- Primary completion
- May 2010 (estimated)
- Study completion
- Jun 2010 (estimated)
- First posted
- 8 May 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A stroke is a sudden loss of brain function. It is caused by the interruption of flow of blood to the brain (ischemic stroke) or the rupture of blood vessels in the brain (hemorrhagic stroke). This study will investigate the use of far infrared radiation for stroke rehabilitation.
Detailed description
A stroke is a sudden loss of brain function. The interruption of blood flow or the rupture of blood vessels causes brain cells (neurons) in the affected area to die. The effects of a stroke depend on where the brain was injured, as well as how much damage occurred. A stroke can impact any number of areas including your ability to move, see, remember, speak, reason and read and write.
It is hereby postulated that irradiation using far infrared, with wavelength between 5 to 20 microns, of the central nervous system, the endocrine system and the whole body could prevent, control, manage or possibly lead to complete rehabilitation of people with stroke.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Radiation: Far Infrared RadiationRadiation: Far Infrared Radiation (5μm to 20μm wavelength) |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- People with Stroke
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Far Infrared RadiationRadiation: Far Infrared Radiation (5μm to 20μm wavelength) Far Infrared radiation for 30 to 40 minutes per treatment session. | Radiation | 1 |
Primary outcome
Management and Cure of Stroke
Time frame: 2 Years
1 secondary outcome
Rehabilitation of the following: ability to move, see, remember, speak, reason and read and write.
Time frame: 2 Years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2009.
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Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ken Nedd, M.D. principal investigator
GAAD Medical Research Institute Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Far Infrared Radiation in people with Stroke, run by GAAD Medical Research Institute Inc. at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Jan 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Management and Cure of Stroke (time frame: 2 Years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jan 2009.