Study Purpose:
The purpose of the study is to learn about inflammation in the brains of people with early ALS (<18 months since weakness onset) & Hereditary Spastic Paraplegia (HSP) using combined Magnetic Resonance Imaging (MRI) and PositronEmission Tomography (PET). Previous research has shown increased brain inflammation in ALS patients, and our study aims to further understand this relationship and to investigate inflammation in other neurodegenerative diseases such as HSP. Participation requires 1-2 visits at MGH over a three month period. Participants must be 18-80 years old, medically safe to undergo an MRI scan and able to safely lie flat for 90 minutes.
Study Status:
Recruiting
Disease:
Amyotrophic Lateral Sclerosis (ALS) , Familial ALS , Sporadic ALS , Primary Lateral Sclerosis (PLS) , Hereditary Spastic Paraplegia (HSP) , Healthy Volunteer , Healthy Volunteer with a Family History of ALS
Study Type:
Observational
Type of Intervention:
N/A
Intervention Name:
N/A
Placebo:
N/A
Phase:
N/A
Study Chair(s)/Principal Investigator(s):
Suma Babu, Massachusetts General Hospital
Clinicaltrials.gov ID:
Neals Affiliated?
No
Coordinating Center Contact Information
Massachusetts General Hospital
Ryan Gifford / email hidden; JavaScript is required / 617- 724-0783
165 Cambridge Street
Boston, Massachusetts, 02114 United States
Full Study Summary:
Massachusetts General Hospital is seeking individuals to participate in a research study enrolling under the direction of Suma Babu, MD. The purpose of the study is to learn more about inflammation in the brains of people with Motor Neuron Disease (MND) using combined Magnetic Resonance Imaging (MRI) and Positron Emission Tomography (PET). Our study will examine whether particular cells, called microglia, are hyperactive in the nervous system of people with MND, such as those individuals with Amyotrophic Lateral Sclerosis (ALS). This information could help improve the diagnosis and development of treatments for other patients with MND in the future.
This study aims to enroll the following cohorts of individuals:
- Individuals with a diagnosis of MND: ALS, Primary Lateral Sclerosis (PLS), Hereditary Spastic Paraplegia (HSP)
- Healthy individuals who are known carriers of an ALS gene such as chromosome 9 open reading frame 72 (C9orf72) or superoxide dismutase 1 (SOD1)
- Individuals with a diagnosis of Frontotemporal Dementia (FTD)
- Healthy individuals without any neurodegenerative disease and no family history of MND
Study participation involves two visits to MGH over a maximum of three months (these visits can also be completed in one day). During the visit(s), participants will undergo a 90-minute MR-PET scan. Participants with MND will also undergo a breathing test, muscle test and questionnaires, and may choose to participate in an optional lumbar puncture (not to be completed on the same day as the scan). Individuals with MND may elect to participate for up to four years in up to 9 optional follow-up scans approximately every three months for the first year and every six months for the following three years. Individuals who do not have MND but are known ALS gene carriers may elect to participate in up to 7 optional follow-up scans approximately every six months for up to four years.
Participants must be between the ages of 18 and 80, be medically safe to undergo an MRI scan (i.e., no metallic particles in the body), and be able to safely lie flat for at least 90 minutes. Additionally, participants cannot be taking any immunosuppressive medications or have a diaphragm pacing system and cannot have a diagnosis of Parkinson’s disease, Alzheimer’s disease, unstable psychiatric disease, or renal failure.
All participants will be reimbursed for parking and receive compensation of $150 upon completion of each MR-PET scan. There will be additional compensation of $100 for each lumbar puncture completed by individuals with MND.
Study Sponsor:
Neurodegenerative Disease Pilot Study Grant, K23 NS 083715, Evan and Arlene Yegelwel Endowed Fund for Primary Lateral Sclerosis Research and Care, PET Imaging of inflammation and epigenetics in ALS (ALS ONE), Muscular Dystrophy Association, Sundry
Participant Duration:
Study participation involves two visits to MGH over a maximum of three months (these visits can also be completed in one day). During the visit(s), participants will undergo a 90-minute MR-PET scan. Participants with MND will also undergo a breathing test, muscle test and questionnaires, and may choose to participate in an optional lumbar puncture (not to be completed on the same day as the scan). Individuals with MND may elect to participate for up to four years in up to 9 optional follow-up scans approximately every three months for the first year and every six months for the following three years. Individuals who do not have MND but are known ALS gene carriers may elect to participate in up to 7 optional follow-up scans approximately every six months for up to four years.
Estimated Enrollment:
300
Estimated Study Start Date:
02 / 28 / 2018
Posting Last Modified Date:
12 / 01 / 2022
Date Study Added to neals.org:
04 / 10 / 2018
Minimum Age:
18
Maximum Age:
80
Can participants use Riluzole?
Yes
Massachusetts General Hospital
Jingqi Zhu / 617-643-2522 / email hidden; JavaScript is required
Dario Gelevski / 617-726-0563 / email hidden; JavaScript is required
Boston, Massachusetts
02114
United States