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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01495390
Other study ID # BIO-ALS-02
Secondary ID
Status Completed
Phase N/A
First received December 16, 2011
Last updated May 24, 2017
Start date November 2011
Est. completion date December 31, 2016

Study information

Verified date May 2017
Source Massachusetts General Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The purpose of this study is to collect biofluid samples for the banking and usage in ALS research. Through comparison of these samples, the researchers hope to learn more about the underlying cause of ALS, as well as find unique biological markers, which could be used to develop new therapies.


Description:

The purpose of the research study is to collect blood samples and cerebrospinal fluid (CSF) from people with amyotrophic lateral sclerosis (ALS). These samples will be collected approximately every 4 months.


Recruitment information / eligibility

Status Completed
Enrollment 139
Est. completion date December 31, 2016
Est. primary completion date December 31, 2016
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Age 18 or older

- Diagnosis of suspected, possible, probable or definite ALS according to El Escorial Criteria

- Vital capacity (VC) at least 50 percent predicted

- Able to undergo multiple lumbar punctures

Exclusion Criteria:

- Abnormal CSF pressure or intracranial/intraspinal tumors

- Use of anticoagulant medication that cannot be safely withheld

- Bleeding disorders

- This is a partial listing.

Study Design


Locations

Country Name City State
United States Emory University Atlanta Georgia
United States Massachusetts General Hospital Boston Massachusetts
United States Mayo Clinic Jacksonville Jacksonville Florida
United States Barrow Neurological Institute Phoenix Arizona
United States University of Pittsburgh Pittsburgh Pennsylvania
United States University of Massachusetts Medical Center Worcester Massachusetts

Sponsors (3)

Lead Sponsor Collaborator
Massachusetts General Hospital ALS Association, ALS Finding a Cure

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary ALS Functional Rating Scale The ALSFRS-R is a quickly administered (5 min) ordinal rating scale used to determine a subject's assessment of their capability and independence in 12 functional activities. There are 12 questions, graded by the subject 0-4 (4 is normal). Score of 0 (worst) to 48 (best). Reflects speech and swallowing, fine motor skills, large motor skills, and breathing. Approximately every 4 months
Primary Vital Capacity (VC) The vital capacity (VC) (percent of predicted normal) was determined using the slow VC method. Vital Capacity is the maximum amount of air a person can expel from the lungs after a maximum inhalation. A subject's VC depends on their age, sex and height. The value is recorded as a percent of predicted normal. Approximately every 4 months
Primary Hand Held Dynamometry (HHD) Hand Held Dynamometry (HHD) will be used as a quantitative measure of muscle strength for this study. Six proximal muscle groups will be examined bilaterally in both upper and lower extremities (shoulder flexion, elbow flexion, elbow extension, hip flexion, knee flexion, and knee extension), all of which have been validated against maximum voluntary isometric contraction (MVIC) testing. Approximately every 4 months
Primary Ashworth Spasticity Scale This is a standard measure for spasticity, has been used in a previous ALS clinical trials, and is applied in the current trial to evaluate the progression of spasticity due to upper motor neuron dysfunction in ALS. Approximately every 4 months
Primary Fronto-Temporal Dementia (FTD) Assessment The FTD Screening Assessment is a quickly administered scale used to evaluate memory, executive functions, and language. It is aimed at determining the presence of subtle dysfunction of these domains of cognition and behavior that may portend the onset of FTD or FTD-like symptoms. Approximately every 4 months
Primary ALS Cognitive Behavioral Screen (ALS CBS) The ALS Cognitive Behavioral Screen (ALS-CBS™) is a short measure of cognition and behavior in patients with Amyotrophic Lateral Sclerosis (ALS). The cognitive section includes commonly used elements of standard testing batteries, consisting of 8 tasks, with a possible total score of 20. It can be administered by a physician or other clinical care staff and takes approximately 5 minutes to complete.
The behavioral section (ALS Caregiver Behavioral Questionnaire) is composed of questions sensitive to organic brain changes. It consists of a set of questions that compare changes in personality and behavior since the onset of ALS, as well as yes/no questions about mood, pseudobulbar affect, and fatigue. It is completed by a caregiver, family member or other informant during the same time that the patient completes the cognitive portion. The questionnaire typically takes about 2 minutes to complete.
Approximately every 4 months
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