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Far Infrared Irradiation for Stroke Rehabilitation

Primary Purpose

Stroke

Status

Unknown status

Phase

Phase 1

Locations

Canada

Study Type

Interventional

Intervention

Far Infrared Radiation

About this trial

This is an interventional treatment trial for Stroke focused on measuring Apoplexy, Cerebral Stroke, Cerebrovascular Accident, Cerebrovascular Accident, Acute, Cerebrovascular Apoplexy, Cerebrovascular Stroke

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

People with Stroke

Exclusion Criteria:

None

Sites / Locations

The Centre for Incurable Diseases

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Arm Description

Radiation: Far Infrared Radiation (5μm to 20μm wavelength)

Outcomes

Primary Outcome Measures

Management and Cure of Stroke

Secondary Outcome Measures

Rehabilitation of the following: ability to move, see, remember, speak, reason and read and write.

Full Information

NCT ID

NCT00675155

First Posted

May 6, 2008

Last Updated

January 2, 2009

Sponsor

GAAD Medical Research Institute Inc.

1. Study Identification

Unique Protocol Identification Number

NCT00675155

Brief Title

Far Infrared Irradiation for Stroke Rehabilitation

Official Title

Phase 1 Study to Determine the Efficacy of Using Far Infrared Radiation for Stroke Rehabilitation

Study Type

Interventional

2. Study Status

Record Verification Date

January 2009

Overall Recruitment Status

Unknown status

Study Start Date

May 2008 (undefined)

Primary Completion Date

May 2010 (Anticipated)

Study Completion Date

June 2010 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor

GAAD Medical Research Institute Inc.

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

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

Stroke

Keywords

Apoplexy, Cerebral Stroke, Cerebrovascular Accident, Cerebrovascular Accident, Acute, Cerebrovascular Apoplexy, Cerebrovascular Stroke

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

Radiation: Far Infrared Radiation (5μm to 20μm wavelength)

Intervention Type

Radiation

Intervention Name(s)

Far Infrared Radiation

Intervention Description

Radiation: Far Infrared Radiation (5μm to 20μm wavelength) Far Infrared radiation for 30 to 40 minutes per treatment session.

Primary Outcome Measure Information:

Title

Management and Cure of Stroke

Time Frame

2 Years

Secondary Outcome Measure Information:

Title

Rehabilitation of the following: ability to move, see, remember, speak, reason and read and write.

Time Frame

2 Years

10. Eligibility

Sex

All

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: People with Stroke Exclusion Criteria: None

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ken Nedd, M.D.

Organizational Affiliation

GAAD Medical Research Institute Inc.

Official's Role

Principal Investigator

Facility Information:

Facility Name

The Centre for Incurable Diseases

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M4V 1L5

Country

Canada

12. IPD Sharing Statement

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Far Infrared Irradiation for Stroke Rehabilitation

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