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)

A Study on Safety of tDCS One-shot in UCP

Sponsors

Lead sponsor: IRCCS Fondazione Stella Maris

Source IRCCS Fondazione Stella Maris
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).

Overall Status Completed
Start Date March 20, 2017
Completion Date December 30, 2017
Primary Completion Date October 20, 2017
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
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)
Secondary Outcome
Measure Time Frame
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)
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)
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)
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)
Enrollment 8
Condition
Intervention

Intervention type: Device

Intervention name: real tDCS

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

Arm group label: real tDCS

Intervention type: Device

Intervention name: sham tDCS

Description: one-shot of sham tDCS session (20 minutes) with BrainStim Stimulator.

Arm group label: Sham tDCS

Eligibility

Criteria:

Inclusion Criteria:

- Symptomatic Unilateral Cerebral Palsy

- Informed consent

Exclusion Criteria:

- Any contraindication for tDCS

Gender: All

Minimum age: 10 Years

Maximum age: 28 Years

Healthy volunteers: No

Overall Official
Last Name Role Affiliation
Giovanni Cioni, MD Study Director IRCCS Fondazione Stella Maris, Università di Pisa
Location
facility
IRCCS Fondazione Stella Maris
Location Countries

Italy

Verification Date

August 2019

Responsible Party

Responsible party type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Arm group label: real tDCS

Arm group type: Experimental

Description: one-shot of real tDCS session (1.5mA; 0.06 mA/cm2 for 20 minutes) with BrainStim Stimulator. The anode electrode is placed in a primary motor cortex (M1) of ipsilesional hemisphere (EEG 10/20 system), while cathode is placed in the supraorbital region (SO) of the contralateral hemisphere.

Arm group label: Sham tDCS

Arm group type: Sham Comparator

Description: one-shot of sham tDCS session with BrainStim Stimulator (20 minutes). The montage of the electrodes will be placed as in the experimental session i.e.the anode electrode will be placed in a primary motor cortex (M1) of ipsilesional hemisphere (EEG 10/20 system), while cathode in the supraorbital region (SO) of the contralateral hemisphere.

Patient Data No
Study Design Info

Allocation: Randomized

Intervention model: Crossover Assignment

Intervention model description: Each subject receives, randomly, a real session of tDCS and a sham session with BrainStim Stimulator.

Primary purpose: Other

Masking: Quadruple (Participant, Care Provider, 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.

Source: ClinicalTrials.gov