Far Infrared Irradiation for Stroke Rehabilitation | NCT00675155

Studies
Far Infrared Irradiation for Stroke Rehabilitation

NCT00675155

Sponsor

GAAD Medical Research Institute Inc.

Status

Unknown status

Last Update Posted

Jan 5, 2009Estimated

Enrollment

10Estimated

Phase

Phase 1

Conditions

Stroke

Interventions

Far Infrared Radiation

Countries

Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2009

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2008

Primary Completion Date

May 2010Estimated

Completion Date

Jun 2010Estimated

First Submitted Date

May 6, 2008

First Submission Date that Met QC Criteria

May 7, 2008

First Posted Date

May 8, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 2, 2009

Last Update Posted Date

Jan 5, 2009Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

10Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental	Radiation: Far Infrared Radiation (5μm to 20μm wavelength)	Radiation: Far Infrared Radiation

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Far Infrared Radiation	Radiation	Radiation: Far Infrared Radiation (5μm to 20μm wavelength) Far Infrared radiation for 30 to 40 minutes per treatment session.	1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Management and Cure of Stroke		2 Years

Secondary Outcomes

Measure	Description	Time Frame
Rehabilitation of the following: ability to move, see, remember, speak, reason and read and write.		2 Years

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

People with Stroke

Exclusion Criteria:

None

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Ken Nedd, M.D.	GAAD Medical Research Institute Inc.	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
The Centre for Incurable Diseases		Toronto	Ontario	M4V 1L5	Canada

Condition Browse Module

MeSH Terms

ID	Term
D020521	Stroke

Ancestor Terms

ID	Term
D002561	Cerebrovascular Disorders
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided