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Identification of biomarkers of Spinocerebellar Ataxia Type 3

Identification of biomarkers of Spinocerebellar Ataxia Type 3

This study seeks to identify quantifiable SCA3 disease biomarkers that can confirm therapeutic target engagement and efficacy, as well as serve as markers of disease progression.

ClinicalTrials.gov Link: clinicaltrials.gov/ct2/show/NCT03885167

About the Study

Eligible Ataxia Types
SCA3

Type of Study
Research Study

Clinical Trial Phase
N/A

Age Range
Adult 18+

Study Start Date
04/25/2018

Estimated Completion Date
N/A

IRB Approval #
HUM00121991

Location(s)

University of Michigan
Ann Arbor, MI
 

Contact Information

Frank Ferrari
frankfer@med.umich.edu
Phone: 734-232-2352

What does participation in the study entail?

Subjects diagnosed with Spinocerebellar Ataxia Type 3 (SCA3) and healthy controls will be asked to undergo three lumbar punctures to donate cerebral spinal fluid and three blood draws to obtain samples for the purposes of our study. These collections will happen yearly.

What are the potential benefits for participants?

Results from this study may significantly contribute to the biomarker development for SCA research, assisting in both future SCA disease prognosis and clinical trial efficacy studies.

What are the potential risks for participants?

Blood Draw Risks: Removal of blood by a needle and syringe poses a small risk of pain or bruising at the site of the needle stick, but this is temporary. Some people may experience fainting or dizziness, and there is also a slight risk of infection at the site of the needle stick.

Lumbar Puncture Risks: During the procedure, you may have temporary pain and discomfort in your back. Headache may occur in people who undergo a lumbar puncture. Occasionally, a low-pressure headache may develop, presumably due to leakage of spinal fluid. If this headache persists it may require additional treatment. Uncommonly a blood patch (injection of some of your blood into the lumbar puncture site to patch the spinal fluid leak) may be required. This usually relieves the headache immediately. Although very rare, it is possible that you may have an allergic reaction to the local anesthetic (lidocaine 1%) used for the lumbar puncture. This would cause swelling and a rash on your skin where the anesthetic was injected. Please tell us if you have ever had a reaction to local anesthetic before (such as when you were visiting the dentist). Potential but rare risks of lumbar puncture include infection, damage to nerves in your back, and bleeding that may affect the spinal cord or brain. The risk of these is very small. There is no risk of paralysis.

Is there financial compensation?

Yes. $225 per completion of lumbar puncture and blood draw.

Is there travel reimbursement?

Yes. Up to $1,500.

Who is eligible?

Inclusion:
Those who are over the age of 18.
Healthy controls who do not have an SCA diagnosis or those with genetically tested and confirmed diagnosis of SCA3.

Exclusion:
Cannot currently taking anti-coagulation medications.
Cannot currently have an unstable/untreated medical issue.
Cannot have a malignant tumor of any kind
Have not had a severe acute infection/have a chronic infection in the past 3 months
Cannot be pregnant or breast-feeding.
Cannot be on an investigation medication.

View Other Research Opportunities

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This study seeks to identify quantifiable SCA3 disease biomarkers that can confirm therapeutic target engagement and efficacy, as well as serve as markers of disease progression.

ClinicalTrials.gov Link: clinicaltrials.gov/ct2/show/NCT03885167

About the Study

Eligible Ataxia Types
SCA3

Type of Study
Research Study

Clinical Trial Phase
N/A

Age Range
Adult 18+

Study Start Date
04/25/2018

Estimated Completion Date
N/A

IRB Approval #
HUM00121991

Location(s)

University of Michigan
Ann Arbor, MI
 

Contact Information

Frank Ferrari
frankfer@med.umich.edu
Phone: 734-232-2352

What does participation in the study entail?

Subjects diagnosed with Spinocerebellar Ataxia Type 3 (SCA3) and healthy controls will be asked to undergo three lumbar punctures to donate cerebral spinal fluid and three blood draws to obtain samples for the purposes of our study. These collections will happen yearly.

What are the potential benefits for participants?

Results from this study may significantly contribute to the biomarker development for SCA research, assisting in both future SCA disease prognosis and clinical trial efficacy studies.

What are the potential risks for participants?

Blood Draw Risks: Removal of blood by a needle and syringe poses a small risk of pain or bruising at the site of the needle stick, but this is temporary. Some people may experience fainting or dizziness, and there is also a slight risk of infection at the site of the needle stick.

Lumbar Puncture Risks: During the procedure, you may have temporary pain and discomfort in your back. Headache may occur in people who undergo a lumbar puncture. Occasionally, a low-pressure headache may develop, presumably due to leakage of spinal fluid. If this headache persists it may require additional treatment. Uncommonly a blood patch (injection of some of your blood into the lumbar puncture site to patch the spinal fluid leak) may be required. This usually relieves the headache immediately. Although very rare, it is possible that you may have an allergic reaction to the local anesthetic (lidocaine 1%) used for the lumbar puncture. This would cause swelling and a rash on your skin where the anesthetic was injected. Please tell us if you have ever had a reaction to local anesthetic before (such as when you were visiting the dentist). Potential but rare risks of lumbar puncture include infection, damage to nerves in your back, and bleeding that may affect the spinal cord or brain. The risk of these is very small. There is no risk of paralysis.

Is there financial compensation?

Yes. $225 per completion of lumbar puncture and blood draw.

Is there travel reimbursement?

Yes. Up to $1,500.

Who is eligible?

Inclusion:
Those who are over the age of 18.
Healthy controls who do not have an SCA diagnosis or those with genetically tested and confirmed diagnosis of SCA3.

Exclusion:
Cannot currently taking anti-coagulation medications.
Cannot currently have an unstable/untreated medical issue.
Cannot have a malignant tumor of any kind
Have not had a severe acute infection/have a chronic infection in the past 3 months
Cannot be pregnant or breast-feeding.
Cannot be on an investigation medication.

View Other Research Opportunities

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