NCT07573865

Brief Summary

Unilateral spastic cerebral palsy (USCP) is the most common subtype of cerebral palsy and significantly limits upper limb function. Traditional therapies such as constraint-induced movement therapy (CIMT) and bimanual intensive training offer limited benefits. Pharmacologic treatments often produce behavioral side effects and do not address underlying neuro-plastic deficits. There is an unmet need for safe, effective, non-invasive interventions targeting motor recovery through cortical modulation.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
4mo left

Started Apr 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress7%
Apr 2026Aug 2026

First Submitted

Initial submission to the registry

December 2, 2025

Completed
5 months until next milestone

Study Start

First participant enrolled

April 30, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 7, 2026

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2026

Last Updated

May 7, 2026

Status Verified

May 1, 2026

Enrollment Period

3 months

First QC Date

December 2, 2025

Last Update Submit

May 4, 2026

Conditions

Cerebral Palsy (CP)Unilateral Cerebral PalsySpastic Cerebral Palsy (sCP)

Keywords

Cerebral PalsySpasticitytDCS

Outcome Measures

Primary Outcomes (1)

  • ABILHAND-KIDS

    ABILHAND-Kids is used to measure a child's manual ability (using their hands/arms) for daily tasks, especially for children with conditions like cerebral palsy or brachial plexus birth injury.

    baseline, after 1 week of intervention

Secondary Outcomes (5)

  • Box and Block test

    Baseline, after 1 week of intervention

  • Movement-related cortical potentials

    baseline, 1 week after intervention

  • Event-related desynchronization (ERD) / synchronization (ERS)

    baseline, 1 week after intervention

  • Resting-state sensorimotor beta/mu power

    baseline, 1 week after intervention

  • NIH Toolbox Cognitive and Emotional Scores

    baseline, 1 week after intervention

Study Arms (2)

Anodal tDCS

ACTIVE COMPARATOR

5 sessions of 20-minute anodal tDCS over the affected motor cortex Concurrent 20-minute therapist-guided bimanual training Standardized protocol for stimulation site and parameters Sessions spread over 1-2 weeks (with 1-week buffer for make-up)

Other: Anodal tDCS

Sham tDCS

SHAM COMPARATOR

5 sessions of 20-minute sham tDCS over the affected motor cortex Concurrent 20-minute therapist-guided bimanual training Standardized protocol for stimulation site and parameters Sessions spread over 1-2 weeks

Other: Sham tDCS

Interventions

Anodal tDCSOTHER

Anodal tDCS will be applied to the affected motor cortex area for 20 minutes along with the bimanual motor training. The intervention will be applied for 5 days in 1-2 weeks.

Anodal tDCS
Sham tDCSOTHER

Sham tDCS will be applied to the affected motor cortex for 20 minutes along with the bimanual motor training. The intervention will be applied for 5 days in 1-2 weeks.

Sham tDCS

Eligibility Criteria

Age6 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Children aged 6-17 years with unilateral spastic CP
  • Wrist extension ≥ 20°, MCP/PIP joints ≥ 10°

You may not qualify if:

  • Any other neurological disorders
  • An orthopedic condition affecting the participation in UE activities.
  • Unable to understand the command.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pakistan Railway Hospital

Rawalpindi, Punjab Province, Pakistan

Location

Related Publications (1)

  • Inguaggiato E, Bolognini N, Fiori S, Cioni G. Transcranial Direct Current Stimulation (tDCS) in Unilateral Cerebral Palsy: A Pilot Study of Motor Effect. Neural Plast. 2019 Jan 15;2019:2184398. doi: 10.1155/2019/2184398.

    PMID: 30733800BACKGROUND

MeSH Terms

Conditions

Cerebral PalsyMuscle Spasticity

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMuscular DiseasesMusculoskeletal DiseasesMuscle HypertoniaNeuromuscular ManifestationsNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeuticsConvulsive TherapyPsychiatric Somatic TherapiesBehavioral Disciplines and ActivitiesElectroshockPsychological Techniques

Study Officials

  • Mirza Obaid Baig, MS

    Riphah International University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Mirza Obaid Baig Assistant Professor, MS

CONTACT

00923332238706obaid.baig@riphah.edu.pk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 2, 2025

First Posted

May 7, 2026

Study Start

April 30, 2026

Primary Completion (Estimated)

July 31, 2026

Study Completion (Estimated)

August 31, 2026

Last Updated

May 7, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

Locations

PA(1)