Neuromodulation studies mix a precise device protocol with clinician-rated and patient-reported scales. Capture records stimulation parameters per session, keeps sham allocation blinded, collects ratings and diaries, and logs side effects, with a free sandbox to build it first.
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Parameters
Modality
MODALTarget site
TRGSITECurrent
INTENSDuration delivered
DURDELImpedance within limit?
IMPOKTolerability
Scalp discomfort
DISCOMNeuromodulation trial data in brief
The study type
Transcranial direct current stimulation (tDCS) and transcranial magnetic stimulation (TMS, including repetitive TMS) are non-invasive brain stimulation methods used in research on conditions such as depression, chronic pain, stroke rehabilitation, cognition and addiction. A typical protocol delivers a course of sessions over weeks, often daily on weekdays, with assessments before, during and after, and a follow-up period. This page does not assess whether any approach works. It covers what data an electronic data capture system must hold so the trial can be analysed, audited and replicated.
Compared with a drug study, there is no dispensed pack to count. Exposure is the session: its target, dose parameters, whether it was completed and what the participant felt. Because the course is long, most sessions are carried out by a technician or nurse, while a separate rater assesses symptoms at set visits. Splitting those two roles is a common design choice to protect blinding, and it affects how access should be set up. For the surrounding clinical field see EDC for CNS and neurology trials, and for related cognition studies EDC for Alzheimer's and dementia trials.
Study owner
Builds and configures the study
Principal investigator
Oversees the site, signs off the casebook
Sub-investigator
Enters and signs clinical data
Study coordinator
Screens subjects, enters visit data
Monitor (CRA)
Verifies data, raises queries
Data manager
Reviews, freezes and locks data
Participant
Completes their own questionnaires
Data model
| Data group | Typical fields | How it fits in Capture |
|---|---|---|
| Eligibility and screening | Inclusion and exclusion items, safety screening questions, prior treatments | Eligibility form and the screening wizard; consent before any procedure |
| Stimulation session | Modality, target site, intensity, duration, number of pulses or trains, coil or electrode placement, impedance check | eCRF form, one record per session, parameters as typed fields with ranges |
| Session deviations | Stopped early, parameters changed, equipment fault | Coded fields plus a reason; edit checks flag out-of-range values |
| Clinician-rated scales | Rated at baseline, mid-course, end of treatment and follow-up | Site-completed eCRF forms; the rater is a distinct role |
| Patient-reported outcomes | Mood, pain, sleep or cognition diaries between visits | ePRO on the participant's phone with reminders and completion windows |
| Tolerability and safety | Scalp discomfort, headache, skin reactions, seizure-related screening, adverse events | Per-session item plus adverse event, AESI and SAE workflow |
| Concomitant treatment | Medication and psychotherapy changes during the course | Concomitant medications template as a repeating table |
| Allocation | Active or sham, stratification, blinding checks | Randomisation with stratification; blinded roles get masked views |
Blinding
Sham designs rely on a convincing procedure and on people who cannot tell the difference. In the data system, that comes down to who can see what. Capture's blinded roles never receive treatment-arm values, and the masking happens in the database layer, not just on screen, so an export or a filter cannot reveal allocation to a blinded user. The technician who delivers sessions may need to know the device programme, even if the arm label is withheld; model that with a programme code instead of an arm name. See clinical trial randomization software for allocation and stratification, which also describes blinded roles.
Add a blinding check. Many protocols ask participants and raters, at the end of treatment, to guess which arm they were in. That is a short form with two questions, and it belongs in the data set so the success of blinding can be reported. Because it is a normal eCRF form, it has the same audit trail and edit checks as everything else.
Rater-administered scales such as depression or cognition measures usually carry licence terms. Capture does not supply licensed instruments or verify licences. For participant-completed questionnaires you can record licence number, holder and expiry on the questionnaire; for clinician forms the licence stays with your study documents. Examples of the templates available include the Hamilton depression scale, MoCA and the clinical global impression forms, each with its own licence note.
Everything is available free in the sandbox. No credit card, no time limit, and you pay only when you go live.
Setup
List each treatment session and each assessment visit. Use the schedule of assessments builder or let the AI study builder read your protocol and draft the visits for you to review.
One form per session with typed fields for each stimulation parameter. Add ranges so a current or duration outside the protocol limit raises an auto-query.
Place clinician-rated forms on the visits where the rater sees the participant, and ePRO tasks between visits with completion windows.
Create technician, rater, coordinator and statistician roles. Configure arms and stratification and test each role in the sandbox.
Use eConsent for the signed form and export the blank eCRF PDF for your committee. See the IRB submission checklist.
Approved forms are locked for live use. Participants can enrol with a site QR code, with no app.
Safety and tolerability
Mild, transient effects such as scalp tingling or headache are common to discuss in neuromodulation protocols, and rare serious events must be caught. The data design should serve both. A one-line tolerability item on every session form gives you a complete record of discomfort per session at almost no cost to staff, while the adverse event form handles anything that meets your protocol's definition of an event. Serious events go through the SAE workflow with the usual sign-off, and every change is written to the audit trail with old value, new value, user and reason.
Define in the protocol which items are events and which are expected tolerability, and mirror that in the forms, so a technician does not have to decide at the keyboard. Capture captures adverse events and SAEs on the eCRF, but it is not a pharmacovigilance safety database; if you need case processing or regulatory safety submissions, use a dedicated system alongside it. See adverse event reporting software for the workflow.
Home and remote elements
Treatment courses are time-bound, and the outcomes people report between visits are the first thing to go missing. Email or SMS reminders with a secure phone-browser link, a reminder ladder that stops itself and completion windows that decide what a late entry means all help here. The ePRO software for clinical trials page covers them in detail. The sleep diary, mood tracker and cognitive focus templates are starting points you can adapt to your own items.
If the protocol includes wearable sleep or activity data, the study team can enable a device per study and participants connect their own account; see EDC for wearable device studies. Treat wearable data as exploratory unless the protocol names it as an endpoint.
Before you start
Every stimulation setting that must be recorded, with allowed ranges.
Technician, rater, coordinator and statistician, with only the access each needs.
What is hidden from whom, plus the end-of-treatment blinding check.
Each instrument's licence handled according to its terms.
Adverse event, AESI and SAE forms exercised in the sandbox.
Post-treatment visits and their windows entered in the schedule.
Yes. Each session is a form with typed fields for settings such as intensity, duration and target site, with ranges and edit checks that raise a query when a value breaks the protocol limits.
Use separate roles. Blinded roles never receive treatment-arm values because masked database views enforce it, and the technician role can work from a programme code.
Yes, as site-completed eCRF forms. Capture does not supply licensed instruments or verify licences, so licence handling stays with your study documents for clinician forms.
Yes. They open on a phone browser from a secure link or QR code with no app, with reminders and completion windows.
No. It is a data capture platform and makes no efficacy or regulatory claim about any stimulation method. This page is not medical or legal advice.
Yes. The sandbox has every feature, no credit card and no time limit. You pay only when the study goes live with real participants.
Keep exploring
EDC for CNS and neurology trials
The wider neurology view.
EDC for Alzheimer's and dementia trials
Cognition-focused designs.
Clinical trial randomization software
Sham and active allocation.
EDC for medical device trials
Device-specific data capture.
ePRO software for clinical trials
Diaries and scales on a phone.
Schedule of assessments builder
Plan the course and the visits.
Free sandbox with every feature. No credit card, and you pay only when you go live.