Cerebral Palsy (CP)NCT07573865
tDCS and Bi-manual Training in Cerebral Palsy
A study testing Anodal tDCS in people with Cerebral Palsy (CP) and Unilateral Cerebral Palsy, run by Riphah International University at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 17 years
- Conditions the study is for
- Cerebral Palsy (CP), Unilateral Cerebral Palsy, Spastic Cerebral Palsy (sCP)
- What is being tested?
- Anodal tDCS
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 15 participants
- Where
- 1 sitePakistan
- Study dates
- 30 Apr 2026to 31 Aug 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children aged 6-17 years with unilateral spastic CP
- Wrist extension ≥ 20°, MCP/PIP joints ≥ 10°
Who cannot join
- Any other neurological disorders
- An orthopedic condition affecting the participation in UE activities.
- Unable to understand the command.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan1 site
Pakistan Railway Hospital
Rawalpindi, Punjab Province
Mirza Obaid Baig Assistant Professor, MS, 00923332238706, obaid.baig@riphah.edu.pk
Mirza Obaid Baig, MSPT
About this study
Official title: 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.
- Being tested
- Anodal tDCS, Sham tDCS
- Keywords
- Cerebral Palsy, Spasticity, tDCS
- Medical subject headings
- Cerebral Palsy, Muscle Spasticity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: 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 Receives: Other: Sham tDCS |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: baseline, after 1 week of intervention
Secondary outcomes (5)
Box and Block test
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
Measured: Baseline, after 1 week of intervention
Movement-related cortical potentials
Movement-related cortical potentials (MRCP) with the help of EEG: peak amplitude, onset latency, and area under the curve at Cz/C3/C4.
Measured: baseline, 1 week after intervention
Event-related desynchronization (ERD) / synchronization (ERS)
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.
Measured: baseline, 1 week after intervention
Resting-state sensorimotor beta/mu power
Resting-state sensorimotor beta/mu power with the help of EEG: absolute and relative power at C3/C4 and central ROI.
Measured: baseline, 1 week after intervention
NIH Toolbox Cognitive and Emotional Scores
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.
Measured: baseline, 1 week after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2026
- Study start30 Apr 2026 (estimated)
- Primary completion31 Jul 2026 (estimated)
- Study completion31 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cerebral Palsy (CP)Studies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Collaborators
- King Fahad Specialist Hospital Dammam
- Responsible party
- Sponsor
- Investigators
- Mirza Obaid Baig, MS, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07573865
- Sponsor's protocol ID
- REC/02477
- Status last verified
- May 2026
- First submitted
- 2 Dec 2025
- Last updated
- 7 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 30733800
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- AI-Assisted Anodal tDCS Combined With Bimanual Motor Training in Children With Unilateral Spastic Cerebral Palsy: A Pilot Feasibility Study at Riphah Hospital
- ClinicalTrials.gov ID
- NCT07573865
- Acronym / sponsor ID
- REC/02477
- Keywords
- Cerebral Palsy, Spasticity, tDCS
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Collaborators
- King Fahad Specialist Hospital Dammam
- Study start
- 30 Apr 2026 (estimated)
- Primary completion
- 31 Jul 2026 (estimated)
- Study completion
- 31 Aug 2026 (estimated)
- First posted
- 7 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Anodal tDCS | Active comparator | Other: Anodal tDCS5 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) |
| Sham tDCS | Sham comparator | Other: Sham tDCS5 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 |
Who may qualify
- Ages
- 6 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Children aged 6-17 years with unilateral spastic CP
- Wrist extension ≥ 20°, MCP/PIP joints ≥ 10°
Key exclusion criteria (3 listed)
- Any other neurological disorders
- An orthopedic condition affecting the participation in UE activities.
- Unable to understand the command.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Anodal tDCSAnodal 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. | Other | Anodal tDCS |
| Sham tDCSSham 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. | Other | Sham tDCS |
Primary outcome
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.
5 secondary outcomes
Box and Block test
Time frame: Baseline, after 1 week of intervention
Movement-related cortical potentials
Time frame: baseline, 1 week after intervention
Event-related desynchronization (ERD) / synchronization (ERS)
Time frame: baseline, 1 week after intervention
Resting-state sensorimotor beta/mu power
Time frame: baseline, 1 week after intervention
NIH Toolbox Cognitive and Emotional Scores
Time frame: baseline, 1 week after intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2026.
- Background: PubMed 30733800Inguaggiato 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.
- Individual participant dataSharing planned: No
Related trials for Cerebral Palsy (CP)
Recruiting
Additional Effects on tDCS With AOT on Lower Limb Functions on Children With Diplegic CP
Diplegic Cerebral Palsy
Recruiting
Comparison of Vestibular Stimulation and Core Stability Training on Sitting Balance in Hypotonic CP
Hypotonic Cerebral Palsy
Not yet recruiting
Video-based Visual Feedback Combined With Task-oriented Physiotherapy Among Cerebral Palsy
Cerebral Palsy (CP)
RecruitingObservational study
Turkish Translation, Cross-Cultural Adaptation, Validity, and Reliability of the ABILHAND-Kids Young CP Scale
Cerebral Palsy
Active, not recruiting
Local Vibration for Drooling in Children With Cerebral Palsy
Cerebral Palsy (CP)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mirza Obaid Baig, MS principal investigator
Riphah International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Anodal tDCS in people with Cerebral Palsy (CP) and Unilateral Cerebral Palsy, run by Riphah International University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 7 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mirza Obaid Baig Assistant Professor, MS (00923332238706, obaid.baig@riphah.edu.pk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ABILHAND-KIDS (time frame: baseline, after 1 week of intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07573865, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2026.