Hemiplegic Cerebral PalsyNCT03137940
A Study on Safety of tDCS One-shot in UCP
A study testing real tDCS in people with Hemiplegic Cerebral Palsy, run by IRCCS Fondazione Stella Maris at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Ages 10 to 28 years
- Conditions the study is for
- Hemiplegic Cerebral Palsy
- What is being tested?
- real tDCS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 8 participants
- Where
- 1 siteItaly
- Study dates
- 20 Mar 2017to 30 Dec 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 10 to 28 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Symptomatic Unilateral Cerebral Palsy
- Informed consent
Who cannot join
- Any contraindication for tDCS
Trial locations and contacts
1 site in 1 country.
About this study
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)
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.
Read the 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).
- Conditions
- Hemiplegic Cerebral Palsy
- Being tested
- real tDCS, sham tDCS
- Keywords
- Unilateral Cerebral Palsy, tDCS, Safety, Upper Limb functions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
real tDCSDevice
one-shot of real tDCS session (1.5mA; 0.06 mA/cm2 for 20 minutes) with BrainStim Stimulator.
sham tDCSDevice
one-shot of sham tDCS session (20 minutes) with BrainStim Stimulator.
| Study group | Role | What they receive |
|---|---|---|
| real tDCS | Experimental | 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. Receives: Device: real tDCS |
| Sham tDCS | Sham comparator | 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. Receives: Device: sham tDCS |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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 (4)
Changes in heart rate [heartbeats per minute]
The heart rate will be measured with an electronic device.
Measured: 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]
The blood pressure will be measured with an electronic device.
Measured: 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)
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
Measured: 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
The hand grip will be measured with a dynamometer. The measurement will be performed firstly with the dominant hand and after with the contralateral.
Measured: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2017
- Study start20 Mar 2017
- Primary completion20 Oct 2017
- Study completion30 Dec 2017
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 Hemiplegic Cerebral PalsyStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Each subject receives, randomly, a real session of tDCS and a sham session with BrainStim Stimulator.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- IRCCS Fondazione Stella Maris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Giovanni Cioni, MD, Study director, IRCCS Fondazione Stella Maris, Università di Pisa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03137940
- Sponsor's protocol ID
- Safety_tDCS1.0
- Status last verified
- Aug 2019
- First submitted
- 18 Apr 2017
- Last updated
- 8 Aug 2019
- Results posted
- No
- Data monitoring committee
- Yes
- 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 8 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT03137940
- Acronym / sponsor ID
- Safety_tDCS1.0
- Conditions
- Hemiplegic Cerebral Palsy
- Keywords
- Unilateral Cerebral Palsy, tDCS, Safety, Upper Limb functions
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- IRCCS Fondazione Stella MarisUniversity, hospital or other
- Study start
- 20 Mar 2017 (actual)
- Primary completion
- 20 Oct 2017 (actual)
- Study completion
- 30 Dec 2017 (actual)
- First posted
- 3 May 2017 (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.
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).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Each subject receives, randomly, a real session of tDCS and a sham session with BrainStim Stimulator.
| Arm | Type | Receives |
|---|---|---|
| real tDCS | Experimental | Device: real tDCSone-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. |
| Sham tDCS | Sham comparator | Device: sham tDCSone-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. |
Who may qualify
- Ages
- 10 to 28 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Symptomatic Unilateral Cerebral Palsy
- Informed consent
Key exclusion criteria (1 listed)
- Any contraindication for tDCS
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 |
|---|---|---|
| real tDCSone-shot of real tDCS session (1.5mA; 0.06 mA/cm2 for 20 minutes) with BrainStim Stimulator. | Device | real tDCS |
| sham tDCSone-shot of sham tDCS session (20 minutes) with BrainStim Stimulator. | Device | Sham tDCS |
Primary outcome
Incidence of Treatment Emergent Adverse Events [Safety and Tolerability]
Time frame: 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
4 secondary outcomes
Changes in heart rate [heartbeats per minute]
Time frame: 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]
Time frame: 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)
Time frame: 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
Time frame: 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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2019.
- Derived from this study: 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
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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. This study is not recruiting at the moment.
Giovanni Cioni, MD study director
IRCCS Fondazione Stella Maris, Università di Pisa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing real tDCS in people with Hemiplegic Cerebral Palsy, run by IRCCS Fondazione Stella Maris at 1 site in Italy.
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 1 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: finished, as of the sponsor's last update on 8 Aug 2019. 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 Italy. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Treatment Emergent Adverse Events [Safety and Tolerability] (time frame: 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)). 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 NCT03137940, 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 8 Aug 2019.