Multicenter PLS Cohort Study of Oxidative Stress and Disease Progression

Study Purpose:

The purpose of this study is to determine whether a physiological process known as oxidative stress has any impact on the rate of disease progression in sporadic PLS.

Study Status:

Not recruiting


Primary Lateral Sclerosis (PLS)

Study Type:


Type of Intervention:


Intervention Name:






Study Chair(s)/Principal Investigator(s):

Hiroshi Mitsumoto, MD (Columbia University) ID:

Neals Affiliated?


Coordinating Center Contact Information

The Eleanor and Lou Gehrig MDA/ALS Research Center

Jonathan Hupf / (212) 342-0949

710 West 168th Street, NI 9th Floor
New York, New York, 10032 United States

Full Study Summary:

Oxidative stress is often triggered by certain environmental exposures, diet, smoking, alcohol consumption, physical activity and psychological stress. Over the course of 36 months, participants in the study are followed through 4 research visits that are usually coordinated with clinic appointments. During these research visits patients undergo the usual physical and neurological examinations that take place during clinic. They are also asked to provide fasting blood and urine samples and to complete cognitive testing and other brief measures. At the time of the baseline research visit, the doctor will also collect a skin biopsy. A phone interview is scheduled within two weeks of each study visit. The baseline interview is typically 1-1.5 hours in duration, and covers a wide range of topics, including the patientā„¢s occupational and residential histories, hobbies, physical activities, questions about how the patient has been feeling, and questions about any military experience the patient may have had.

Study Sponsor:

Spastic Paraplegia Foundation

Estimated Enrollment:


Estimated Study Start Date:

11 / 02 / 2016

Estimated Study Completion Date:

11 / 02 / 2016

Posting Last Modified Date:

01 / 31 / 2016

Date Study Added to

08 / 02 / 2012

Minimum Age:


Inclusion Criteria:
Diagnosis of definite sporadic PLS.
At least 5 years and no more than 15 years since symptom onset.
Age: 20 years or older.
Speaks English.
If the patient has had testing for HSP, the results were normal.
Record of recent EMG done within the last 12 months. If not, patient must be willing to have an EMG done for diagnostic purposes.
Must have a reliable caregiver willing to participate (family member or good friend).

Exclusion Criteria:
History of any other major neurological problems.
Any other unstable medical diseases that required treatment in the past 6 months.
Participating in any drug trials before baseline specimens collected.

University of Kansas Medical Center

Maureen Walsh / (913) 588- 0645

Kansas City, Kansas 66160
United States

University of Kentucky

Debby Taylor / (859) 257-5560

Lexington, Kentucky 40536
United States

University of Texas Southwestern

Nina Gorham / (214) 648-0462

Dallas, Texas 75390-8897
United States

Western University London, Ontario

Christine Piechowicz / (519) 685-8500 x34858

London, Ontario N6A 5A5