Clinical trial NCT03137940: A Study on Safety of tDCS One-shot in UCP
Official title: A Study on Safety and Feasibility of a Session of Transcranial Electrical Stimulation (tDCS "One-shot") in Children and Young Adults With Unilateral Cerebral Palsy (UCP)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hemiplegic Cerebral Palsy
Keywords: Unilateral Cerebral Palsy
tDCS
Safety
Upper Limb functions
Lead sponsor: IRCCS Fondazione Stella Maris
Sponsor class: OTHER
First posted: 2017-05-03
Enrollment: 8
Sex: ALL
Minimum age (years): 10
Maximum age (years): 28
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Each subject receives, randomly, a real session of tDCS and a sham session with BrainStim Stimulator.
Primary purpose: OTHER

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).

Eligibility criteria: Inclusion Criteria:

* Symptomatic Unilateral Cerebral Palsy
* Informed consent

Exclusion Criteria:

* Any contraindication for tDCS

Primary outcomes:
measure: Incidence of Treatment Emergent Adverse Events [Safety and Tolerability]
timeFrame: 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)
Secondary outcomes:
measure: Changes in heart rate [heartbeats per minute]
timeFrame: 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)
measure: Changes in blood pressure [mmHg]
timeFrame: 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)
measure: Changes in Box and Block Test (BBT)
timeFrame: 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)
measure: Changes in Hand Grip
timeFrame: 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)
Other outcomes:
Locations:
city: Calambrone
country: Italy
facility: IRCCS Fondazione Stella Maris
state: Pisa
Study officials:
affiliation: IRCCS Fondazione Stella Maris, Università di Pisa
name: Giovanni Cioni, MD
role: STUDY_DIRECTOR
References:
citation: 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.