A Study on Safety of tDCS One-shot in UCP

Hemiplegic Cerebral Palsy Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03137940
• Other study ID #: Safety_tDCS1.0
• Status: Completed
• Phase: N/A
• Start date: March 20, 2017
• Est. completion date: December 30, 2017

Study information

• Verified date: August 2019
• Source: IRCCS Fondazione Stella Maris
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: December 30, 2017
• Est. primary completion date: October 20, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Years to 28 Years

Eligibility

Inclusion Criteria:

• Symptomatic Unilateral Cerebral Palsy

• Informed consent

Exclusion Criteria:

• Any contraindication for tDCS

Related Conditions & MeSH terms

• Cerebral Palsy
• Hemiplegic Cerebral Palsy

Intervention

Device:
• real tDCS
one-shot of real tDCS session (1.5mA; 0.06 mA/cm2 for 20 minutes) with BrainStim Stimulator.
• sham tDCS
one-shot of sham tDCS session (20 minutes) with BrainStim Stimulator.

Locations

Country	Name	City	State
Italy	IRCCS Fondazione Stella Maris	Calambrone	Pisa

Sponsors (1)

Lead Sponsor	Collaborator
IRCCS Fondazione Stella Maris

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of Treatment Emergent Adverse Events [Safety and Tolerability]	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	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	Changes in heart rate [heartbeats per minute]	The heart rate will be measured with an electronic device.	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)
Secondary	Changes in blood pressure [mmHg]	The blood pressure will be measured with an electronic device.	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)
Secondary	Changes in Box and Block Test (BBT)	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	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)
Secondary	Changes in Hand Grip	The hand grip will be measured with a dynamometer. The measurement will be performed firstly with the dominant hand and after with the contralateral.	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)