Huntington's disease trials build their endpoint from several clinician-run tests, depend on genetic status and a care partner, and often involve lumbar puncture dosing. Capture keeps those pieces in one audit-trailed study. Test free, pay only at go-live.
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What a Huntington's disease trial needs from its EDC
The study data
The registered GENERATION HD1 trial of an intrathecal antisense drug listed the change in cUHDRS and the change in total functional capacity (TFC) as primary outcomes. TFC is scored 0 to 13 with higher being better; the total motor score (TMS) runs 0 to 124 with higher being worse. The composite also uses a symbol-digit modalities test and Stroop word reading. A cUHDRS is only as good as its weakest input: if any one of the four is missing at a visit, the composite is missing too. In Capture each component sits on its own form or section, and a visit checklist makes the missing piece obvious before the participant leaves the clinic.
Placebo and practice effects are well documented in HD. A 2025 analysis comparing a trial placebo group with natural history data reported that functional decline tracked natural history while motor and cognitive scores improved in the placebo arm, with cognitive gains attributed to practice. For data management this means test versions, rater identity, time of day, and order of testing are not nuisance fields. Add them as explicit fields and keep the audit trail on each score so a changed value has a reason attached.
Disease stage and genetic information are the second axis. CAG repeat length and age are commonly combined into disease burden indices used for eligibility and stratification; check whether your protocol uses one before building it. Predictive-testing history and family confidentiality are sensitive. Capture separates identity from coded data with PII segregation and role-based access, and blinded roles never receive treatment arm values. Do not enter family details beyond what the protocol requires.
Rater
RATERTotal functional capacity
TFCSum of function items, read-only
9 CalculatedTotal motor score
TMSChange in functional capacity since baseline
TFCCHGWithin expected annual change
Informant (care partner) present
INFORMProtocol to build
| Protocol element | What the data looks like | Where it lives in Capture |
|---|---|---|
| Functional capacity | Domain items, total 0-13 | Site eCRF form with calculated total |
| Motor examination | Item ratings, total 0-124 | Site eCRF form with rater field and total |
| Cognitive tests | Symbol-digit and Stroop counts, test version, time | Site form per test; see MoCA template for a cognitive form pattern |
| Genetic and stage data | CAG length, diagnostic confidence, onset | Screening form; restricted roles |
| Behavioural and psychiatric | Irritability, apathy, depression, suicidality | PHQ-9 and C-SSRS style forms |
| Intrathecal dosing | Procedure time, needle, CSF volume, post-procedure vitals | Visit form plus vital signs |
| CSF and plasma biomarkers | Collection time, aliquot, shipment | Lab form with sample rows |
| Care partner consent | Participant plus LAR signature as capacity changes | eConsent with LAR support; see legally authorized representative consent |
Instrument wording is yours to supply. Clinician-rated forms have no licence controls in Capture; licences stay with study documents.
Create the four component forms, test the rater and version fields with sample participants, and export the dataset. Free sandbox, no credit card.
Operations
Participants may lose capacity during the study. Capture eConsent supports a Legally Authorized Representative signature next to the participant and countersignature by the investigator, so a re-consent can be recorded. Document in the protocol how capacity is assessed. A care partner often reports functional status and behaviour, so use an informant field on those forms, and a separate caregiver-completed questionnaire where the protocol collects one. Reminders go by email or SMS, and the link opens in the phone browser.
Open-label extensions run for years and are common in HD programmes. See long-term extension study software. For very rare subgroups, such as juvenile onset, or premanifest cohorts, use arms and epochs in the same study. The wider picture of neurology studies is in EDC for CNS and neurology trials, and a close movement-disorder pattern in EDC for Parkinson's disease trials.
Many HD studies are international and tied to registries and natural-history cohorts. Site-level participant numbering, a coordinator portal and by-site exports handle multi-country work, with EU (Frankfurt) or US (N. Virginia) hosting. For rare-disease programmes with few participants per site, see EDC for rare disease clinical trials.
Before first participant
Which assessments make up the composite and in what order.
Added to every component form.
Roles limited to those who need CAG and stage fields.
LAR signature route in eConsent and how re-consent is recorded.
Lumbar puncture and post-procedure safety visits built.
Rating scales and cognitive tests documented in study files.
Yes, as site forms with rater and test version fields. Capture shows read-only totals for summed scales; the composite derivation is done in your analysis programme per the SAP.
Through role-based access, PII segregation and row-level database security. Limit CAG and stage fields to the roles that need them.
Yes. An assessment can be set to be completed by a caregiver from a secure link on their phone.
eConsent supports a Legally Authorized Representative signature and investigator countersignature. How capacity is assessed is defined in the protocol and ethics approval.
Dosing visits are visit forms with procedure time, volume, vitals and post-procedure events. Capture records the data; it does not claim to manage drug supply logistics.
The sandbox is free with every feature and no time limit. You pay once you go live with real participants; see the pricing page.
Free sandbox with every feature. No credit card, and you pay only when you go live.