Hemiplegic Cerebral Palsy
Conditions
Keywords
Unilateral Cerebral Palsy, tDCS, Safety, Upper Limb functions
Brief summary
The study aims to evaluate the safety and the feasibility of transcranial Direct Current Stimulation (tDCS) session in children and young adults with Unilateral Cerebral Palsy (UCP). Secondarily it aims to test the effects of tDCS (real vs sham) in improving, in very short term, Upper Limb (UL) functions.
Detailed description
Unilateral Cerebral Palsy (UCP) represents the most frequent form of CP; the upper limb (UL) is generally more affected than the lower limb with an impact in activity and participation areas. The non-invasive brain stimulation techniques (NIBS), such as transcranial Direct Current Stimulation (tDCS), appear able to modulate neuronal plasticity processes even more late in age attracting great interest for their potential fallout in the field of rehabilitation. The effects of tDCS in recovery of motor function has more investigated in adults, while in the pediatric population studies on safety and efficacy are still few and not conclusive. This study aims to evaluate the safety and the feasibility of tDCS session in children and young adults with UCP both in short term and in follow up (up to 24 hrs after the tDCS session). Secondarily it aims to test the effects of tDCS (real vs sham) in improving, in short term, UL functions. For the study 6 children (aged 10-17 years) and 6 young adults (aged 18-28 years) with UCP will be recruited. Each subject receives, randomly, a real session and a sham session of tDCS with BrainStim Stimulator. Before (T0), immediately after (T1) and after 1 hour and half (T2) to each tDCS session (real or sham) heart rate, blood pressure and UL functions will be measured. Moreover the subject fills in an ad hoc questionnaire on safety at T1 and T2 and, on call, at 24 hours after the sessions (T3).
Interventions
DEVICEreal tDCS
one-shot of real tDCS session (1.5mA; 0.06 mA/cm2 for 20 minutes) with BrainStim Stimulator.
DEVICEsham tDCS
one-shot of sham tDCS session (20 minutes) with BrainStim Stimulator.
Sponsors
IRCCS Fondazione Stella Maris
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
The medical device randomly assigns, to each subject, the sequence of the type of sessions, so no one knows the kind of session performed.
Intervention model description
Each subject receives, randomly, a real session of tDCS and a sham session with BrainStim Stimulator.
Eligibility
Sex/Gender
ALL
Age
10 Years to 28 Years
Healthy volunteers
No
Inclusion criteria
* Symptomatic Unilateral Cerebral Palsy * Informed consent
Exclusion criteria
* Any contraindication for tDCS
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Treatment Emergent Adverse Events [Safety and Tolerability] | The questionnaire will be filled in immediately after the tDCS session (T1), at 1 hour and half from T1 (T2) and, on call, at 24 hours from the tDCS session (T3) | An adapted and child-friendly safety and tolerability questionnaire will be used for children and adolescent, while for young adults a questionnaire already used for this evaluation will be proposed. To explore the long-term safety the questionnaire is enriched with questions about quality of sleep, mood and activities to be answered after 24 hours of tDCS session |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in heart rate [heartbeats per minute] | At baseline (T0, before the tDCS session), immediately after the tDCS session (i.e. 20 minutes after T0), at 1 hour and half from T1 (T2) | The heart rate will be measured with an electronic device. |
| Changes in blood pressure [mmHg] | At baseline (T0, before the tDCS session), immediately after the tDCS session (i.e. 20 minutes after T0), at 1 hour and half from T1 (T2) | The blood pressure will be measured with an electronic device. |
| Changes in Box and Block Test (BBT) | At baseline (T0, before the tDCS session), immediately after the tDCS session (i.e. 20 minutes after T0), at 1 hour and half from T1 (T2) | The BBT measures unilateral gross-manual dexterity; subjects have to move, one by one, the maximum number of blocks from one compartment of a box to another within 60 seconds. The test will be performed firstly with the dominant hand and after with the contralateral. The patient is allowed a 15-second trial period prior to testing. ICF Domain: Activity |
| Changes in Hand Grip | At baseline (T0, before the tDCS session), immediately after the tDCS session (i.e. 20 minutes after T0), at 1 hour and half from T1 (T2) | The hand grip will be measured with a dynamometer. The measurement will be performed firstly with the dominant hand and after with the contralateral. |
Countries
Italy
Outcome results
None listed