Assessment of the safety and effectiveness of tDCS as an add-on therapy for managing upper limb spasticity after stroke: a randomized controlled trial

Safety and efficacy of adjunctive transcranial direct current stimulation (t DCS) in the management of post-stroke upper limb spasticity: a randomized controlled trial - NIL

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2026/02/103047

Enrollment

Registered

2026-02-04

Start date

Unknown

Completion date

Unknown

Last updated

2026-09-14

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

Conditions

Health Condition 1: I693- Sequelae of cerebral infarction

Interventions

Intervention1: Transcranial direct current stimulation (tDCS): tDCS applied over the affected motor cortex, combined with standard rehabilitation therapy for 10 days (weekly 5 sessions for 2 weeks) Co

Eligibility

Inclusion criteria

Inclusion criteria: First ever ischemic or hemorrhagic stroke confirmed clinically and radiologically Stroke onset greater than or equal to 3 months to 2 years before enrolment MAS score greater than or equal to 2 in affected upper limb Stable medication and rehabilitation regimen with no major changes in spasticity drugs in past 4 weeks

Exclusion criteria

Exclusion criteria: History of epilepsy, CNS tumors, or neurodegenerative disorders Pacemaker or metallic implants Recurrent stroke Severe cognitive impairment or psychiatric disorders interfering with participation Pre-existing severe musculoskeletal conditions in affected limb Uncontrolled hypertension or hemodynamic instability Active skin lesions at electrode sites Pregnancy

Design outcomes

Primary

Measure	Time frame
To assess the efficacy of adjunctive tDCS in reducing post-stroke upper limb spasticity compared to sham tDCS alone by measuring the changes in the Modified Ashworth Scale (MAS) score over 4 weeks.Timepoint: Baseline and 4 weeks post-intervention	—

Secondary

Measure	Time frame
To evaluate the safety and tolerability of tDCS in post stroke spasticity at 4 weeksTimepoint: Baseline and 4 weeks post-intervention;To compare changes in motor function using the Fugl-Meyer Assessment upper extremity (FMA-UE) scale be-tween the 2 groups at 4 weeksTimepoint: Baseline and 4 weeks post-intervention;To compare the quality of life improvements using the Stroke Impact Scale between the 2 groups at 4 weeks.Timepoint: Baseline and 4 weeks post-intervention;To compare functional improvement between the 2 groups, including manual dexterity and daily activity performance, using the Jebsen-Taylor Hand Function Test at 4 weeksTimepoint: Baseline and 4 weeks post-intervention;To analyse the sustained effects of tDCS on spasticity at follow-up (3 months post-intervention)Timepoint: Baseline and 4 weeks post-intervention	—

Measure

Time frame

To evaluate the safety and tolerability of tDCS in post stroke spasticity at 4 weeksTimepoint: Baseline and 4 weeks post-intervention;To compare changes in motor function using the Fugl-Meyer Assessment upper extremity (FMA-UE) scale be-tween the 2 groups at 4 weeksTimepoint: Baseline and 4 weeks post-intervention;To compare the quality of life improvements using the Stroke Impact Scale between the 2 groups at 4 weeks.Timepoint: Baseline and 4 weeks post-intervention;To compare functional improvement between the 2 groups, including manual dexterity and daily activity performance, using the Jebsen-Taylor Hand Function Test at 4 weeksTimepoint: Baseline and 4 weeks post-intervention;To analyse the sustained effects of tDCS on spasticity at follow-up (3 months post-intervention)Timepoint: Baseline and 4 weeks post-intervention

—

Countries

India

Contacts

Public ContactRanjeet Kumar

Department of Neurology, Jawaharlal Institute of Postgraduate Medical Education and Research

ranjeetkumar0688@gmail.com8210754221

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Sep 19, 2026