Table 1 Inclusion and exclusion criteria for participants of the MTM-HD study

Age 30–50

Major psychiatric disorder at time of enrolment

Caucasian ethnicity to minimize genetic differences in this relatively small sample set

On long-term anti-coagulants, e.g., Warfarin for mechanical heart valves, pulmonary embolism or atrial fibrillation

Huntington disease gene CAG repeat length 40–55, for gene expanded subjects only

On combination of aspirin and clopidogrel for ischemic heart disease

Premanifest subjects stratified as closer to predicted disease onset (disease burden score > 250, UHDRS diagnostic confidence score < 3)

Any relevant condition (including presence of psychosis and/or confusional states), behavior, laboratory value, or concomitant medication which, in the opinion of the investigator, makes the subject unsuitable for entry into the study

Early HD subjects (stage 1 and 2 disease as quantified by UHDRS total functional capacity score 7–13) aged 30–50

Recent major abdominal or limb surgery within last month

Healthy volunteers aged 30–50

Fear of needles

REGISTRY or ENROLL-HD assessment within 6 months of screening visit, for gene expanded subjects only

Anemia (Hb < 11.5), thrombocytopenia (platelets < 150), or coagulopathy (INR > 1.5) identified on screening and/or blood tests

Presence of companion to accompany them home

High-dose nutraceuticals, e.g., creatinine, co-enzyme Q, vitamin E

Capable of providing informed consent

Significant lower limb impairment of any kind

Subjects must have no clinically significant and relevant history that could affect the conduct of the study and evaluation of the data, as ascertained by the investigator through detailed medical history

Significant cardio-respiratory or other medical co-morbidities such as ischemic heart disease, diabetes, chronic obstructive pulmonary disease, chronic liver disease, stroke with hemiparesis, BMI > 30, and history of malignancy in last 2 years

Ability to tolerate procedures, fasting and blood sample donation

Illicit drug use and/or alcohol abuse > 21 units/week males; 14 units/week female

Participation in an investigational drug trial within 30 days of screening visit

Pregnancy

Allergy/previous adverse reaction to local anesthetic agents