NCT00574054

Brief Summary

This trial is a preliminary study to determine the use of far infrared radiation for the treatment of dementia and other mental sickness.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
4

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Feb 2008

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 12, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 14, 2007

Completed
2 months until next milestone

Study Start

First participant enrolled

February 1, 2008

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2009

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2009

Completed
Last Updated

August 17, 2009

Status Verified

August 1, 2009

Enrollment Period

11 months

First QC Date

December 12, 2007

Last Update Submit

August 14, 2009

Conditions

Dementia

Keywords

Familial DementiaSemantic DementiaSenile Paranoid Dementia

Outcome Measures

Primary Outcomes (1)

  • The primary end point is to determine the therapeutic effects of far infrared radiation on dementia.

    1 year

Secondary Outcomes (1)

  • The secondary end point of the study is to evaluate the therapeutic effects of far infrared radiation on other related mental illness including Alzheimer's, multiple sclerosis and stroke rehabilitation.

    1 year

Study Arms (1)

1

OTHER
Radiation: Far Infrared

Interventions

Far InfraredRADIATION

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

1

Eligibility Criteria

Age2 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Persons age 2 or older, with dementia, Alzheimer's, Huntington's disease, Parkinson's disease, Down's syndrome, multiple sclerosis or stroke

You may not qualify if:

  • Persons with severe mental illness that are confined to mental hospitals etc., as defined by the USA Diagnostic and Statistical Manual of Mental Disorders (DSM)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Centre for Incurable Diseases

Toronto, Ontario, M4V 1L5, Canada

Location

MeSH Terms

Conditions

DementiaFrontotemporal Dementia

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurocognitive DisordersMental DisordersFrontotemporal Lobar DegenerationTDP-43 ProteinopathiesNeurodegenerative DiseasesProteostasis DeficienciesMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Kwasi Donyina, Ph.D.

    GAAD Medical Research Institute Inc.

    PRINCIPAL INVESTIGATOR

  • Ken Nedd, M.D.

    GAAD Medical Research Institute Inc.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 12, 2007

First Posted

December 14, 2007

Study Start

February 1, 2008

Primary Completion

January 1, 2009

Study Completion

March 1, 2009

Last Updated

August 17, 2009

Record last verified: 2009-08

Locations

CA(1)