tDCS and Bi-manual Training in Cerebral Palsy

May 4, 2026 updated by: Riphah International University

AI-Assisted Anodal tDCS Combined With Bimanual Motor Training in Children With Unilateral Spastic Cerebral Palsy: A Pilot Feasibility Study at Riphah Hospital

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

15

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Pakistan
    • Punjab Province
      • Rawalpindi, Punjab Province, Pakistan
        • Pakistan Railway Hospital
        • Principal Investigator:
          • Mirza Obaid Baig, MSPT
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Anodal tDCS
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
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.
Sham Comparator: Sham tDCS
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ABILHAND-KIDS
Time Frame: baseline, after 1 week of intervention
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Box and Block test
Time Frame: Baseline, after 1 week of intervention
The Box and Block Test (BBT) assesses gross manual dexterity in kids with Cerebral Palsy (CP) aged 6-15 by having them move as many 1-inch blocks as possible from one box side to another in 60 seconds, one block at a time, testing each hand separately
Baseline, after 1 week of intervention
Movement-related cortical potentials
Time Frame: baseline, 1 week after intervention
Movement-related cortical potentials (MRCP) with the help of EEG: peak amplitude, onset latency, and area under the curve at Cz/C3/C4.
baseline, 1 week after intervention
Event-related desynchronization (ERD) / synchronization (ERS)
Time Frame: baseline, 1 week after intervention
Event-related desynchronization (ERD) / synchronization (ERS) with the help of EEG: mu (8-13 Hz) and beta (13-30 Hz) ERD magnitude and timing during movement.
baseline, 1 week after intervention
Resting-state sensorimotor beta/mu power
Time Frame: baseline, 1 week after intervention
Resting-state sensorimotor beta/mu power with the help of EEG: absolute and relative power at C3/C4 and central ROI.
baseline, 1 week after intervention
NIH Toolbox Cognitive and Emotional Scores
Time Frame: baseline, 1 week after intervention
The NIH Toolbox for the Assessment of Neurological and Behavioral Function (NIH Toolbox) is a set of standardized measures used by researchers and clinicians to assess motor, cognitive, emotional, and sensory functions.
baseline, 1 week after intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Riphah International University

Collaborators

King Fahad Specialist Hospital Dammam

Investigators

  • Principal Investigator: Mirza Obaid Baig, MS, Riphah International University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 30, 2026

Primary Completion (Estimated)

July 31, 2026

Study Completion (Estimated)

August 31, 2026

Study Registration Dates

First Submitted

December 2, 2025

First Submitted That Met QC Criteria

May 4, 2026

First Posted (Actual)

May 7, 2026

Study Record Updates

Last Update Posted (Actual)

May 7, 2026

Last Update Submitted That Met QC Criteria

May 4, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • REC/02477

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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