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Testing of an AI system that detects and classifies tremors using hand-drawn spirals and comparing it with tremor rating scales in clinical monitoring

Spiral Dx: Real-world Evaluation of an Artificial Intelligence aLgorithm for Tremor detection and classification from hand-drawn spIrals [RE-AI-LTI]: Randomized Control Trial - RE-AI-LTI

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2026/05/110361
Enrollment
500
Registered
2026-05-11
Start date
Unknown
Completion date
Unknown
Last updated
2026-06-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: G250- Essential tremor

Interventions

Intervention1: Nil: Nil Intervention2: Nil: Nil Intervention3: AI-assisted clinical monitoring: AI-assisted clinical monitoring using the Spiral Dx algorithm during clinic visits. Spiral-Dx severity m

Sponsors

Indian Council of Medical Research (ICMR), New Delhi,
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1) Age above 18 years 2) Diagnosis of essential tremor syndrome (ET, ET plus and dystonic tremor syndrome with hand tremor) by a movement disorder specialist according to the 2018 consensus criteria for classification of tremor 3) Moderate or severe ET defined as QUEST-SI more than 11.25

Exclusion criteria

Exclusion criteria: 1) Those who have no intact upper limbs (eg; above wrist amputation, severe weakness resulting in inability to grip pen) 2) Those who refuse consent to participate

Design outcomes

Primary

MeasureTime frame
Primary outcome will be patient reported tremor related QOL as assessed by the QUEST scale at 12 months, which will be compared between the 2 arms.Timepoint: 0,3,6,9,12 months

Secondary

MeasureTime frame
QUEST subdomain indices: physical, psychosocial, communication, hobbies and work/financesTimepoint: 0,12 months;Clinician Global Impression of Change (CGIC)Timepoint: 0, 12 months;Patient Global Impression of Change (PGIC)Timepoint: 0, 12 months;Fahn-Tolosa-Marin Tremor Rating ScaleTimepoint: 0,3,6,9, 12 months;Edinburgh Handedness InventoryTimepoint: 0 months;Patient satisfaction with follow-up visits (on a visual analogue scale)Timepoint: 0, 12 months;Time taken for follow up assessmentsTimepoint: 0, 12 months;Adverse eventsTimepoint: 0, 12 months;Frequency of dosage changesTimepoint: 0, 12 months;Frequency of medication changesTimepoint: 0, 12 months

Countries

India

Contacts

Public ContactDr Roopa Rajan

AIIMS

rooparajan@aiims.edu01126593662

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Jun 11, 2026