AzTrials
AzTrials

Stroke, IschemicNCT04166968

Multicenter Study on the Efficacy of Transcranial Direct Current Stimulation (tDCS) in Post-stroke Motor Recovery

A study testing Anodal transcranial direct current stimulation (A-tDCS), Cathodal transcranial direct current stimulation (C-tDCS) and Neuromotor training in people with Stroke, Ischemic and Stroke Hemorrhagic, run by IRCCS Centro San Giovanni di Dio Fatebenefratelli at 1 site in Italy.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial summary

Several previous studies have used tDCS as a neuromodulation tool, showing improvements in several diseases (Lefaucheur et al., 2017). Based on these observations, it is believed that the use of tDCS in combination with specific motor training may provide the opportunity to induce behavioral improvements in patients… Read more about this study

Who is it for?
Ages 18 to 90 years
Conditions the study is for
Stroke, Ischemic, Stroke Hemorrhagic
What is being tested?
Anodal transcranial direct current stimulation (A-tDCS), Cathodal transcranial direct current stimulation (C-tDCS) and Neuromotor training
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
162 participants
Where
1 siteItaly
Study dates
10 Oct 2019to Dec 2020
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 18 to 90 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • First-ever ischemic stroke
  • Red or white stroke
  • Barthel Index > 90 before lesion onset

Who cannot join

  • Previous inborn neurological disease
  • Previous acquired neurological disease
  • Previous or current major psychiatric illness
  • Epilepsy or anticonvulsant treatment
  • Use of calcium channel blocker drugs
  • Treatments with other technologies (robotics, FES, etc.)
  • Neurolytic treatments with botulinum toxin

Trial locations and contacts

1 site in 1 country.

Maria Concetta Pellicciari, PhD contact

+39 030 3501597

studioitalianotdcs@gmail.com

Italy1 site, 1 recruiting

  • IRCCS Centro San Giovanni di Dio Fatebenefratelli

    Brescia, Lombardy, 25125

    Carlo Miniussi

    Recruiting

Other trials in Italy

About this study

Several previous studies have used tDCS as a neuromodulation tool, showing improvements in several diseases (Lefaucheur et al., 2017). Based on these observations, it is believed that the use of tDCS in combination with specific motor training may provide the opportunity to induce behavioral improvements in patients with motor deficits. As shown in previous reports brain stimulation can, in fact, interact with the intrinsic ability of the brain to "repair" damaged brain functions, increasing the involvement of compensatory functional networks and thus inducing neuroplasticity. If these low-cost, easy-to-use stimulation techniques prove to be useful in improving motor deficits with long-term effects, the current study would open up new and interesting avenues in the field of neurorehabilitation. Given the potential long-lasting effects of tDCS, there is currently a growing interest in the clinical sector with the aim to reduce motor deficits in patients with brain injury. The most widely used protocols in stroke patients include the application of either anodal on the hypsilesional hemisphere or cathodal tDCS on the unaffected hemisphere (contralateral), so as to increase and decrease the excitability of the motor cortex, respectively (Nitsche and Paulus, 2001).

The main objective of this study is to evaluate the effectiveness of transcranial direct current stimulation in enhancing the functional recovery of the upper limb of stroke patients after three weeks of neuromotor training and subsequent follow-up. The secondary objective is to evaluate the treatment effects on balance, gait, motor dexterity and disability, besides the functional recovery of the lower limb.

Being tested
Anodal transcranial direct current stimulation (A-tDCS), Cathodal transcranial direct current stimulation (C-tDCS), Sham stimulation (sham-tDCS), Neuromotor training
Keywords
transcranial direct current stimulation, stroke rehabilitation
Medical subject headings
Ischemic Stroke, Hemorrhagic Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Anodal transcranial direct current stimulation (A-tDCS)Device

    Anodal tDCS will be performed for 20 minutes over the affected hemisphere with an intensity set to 2 mA

  • Cathodal transcranial direct current stimulation (C-tDCS)Device

    Cathodal tDCS will be performed for 20 minutes over the unaffected hemisphere with an intensity set to 2 mA

  • Sham stimulation (sham-tDCS)Device

    placebo stimulation

  • Neuromotor trainingBehavioural

    conventional neuromotor treatment

Study groups in NCT04166968
Study groupRoleWhat they receive
Control GroupSham comparatorneuromotor training and placebo stimulation
Receives: Device: Sham stimulation (sham-tDCS); Behavioral: Neuromotor training
Group 1Experimentalneuromotor training and cathodal stimulation over the unaffected hemisphere
Receives: Device: Cathodal transcranial direct current stimulation (C-tDCS); Behavioral: Neuromotor training
Group 2Experimentalneuromotor training and anodal stimulation over the affected hemisphere
Receives: Device: Anodal transcranial direct current stimulation (A-tDCS); Behavioral: Neuromotor training

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Changes from Baseline Fugl Meyer Assessment Scale (FMA)

    Performance-based assessment of sensorimotor impairment

    Measured: End of 1st week; End of 2nd week; End of 3rd week; 90 days follow-up

Secondary outcomes (6)

  1. Changes from Baseline Box & Block Test (B&B)

    test for manual dexterity of upper extremity function

    Measured: End of 1st week; End of 2nd week; End of 3rd week; 90 days follow-up

  2. Changes from Baseline Barthel Index (BI)

    measure of daily living activities in relation to personal care and mobility of the patient

    Measured: End of 1st week; End of 2nd week; End of 3rd week; 90 days follow-up

  3. Changes from Baseline Trunk Control Test (TCT)

    assessment of the deteriorations in trunk control

    Measured: End of 1st week; End of 2nd week; End of 3rd week; 90 days follow-up

  4. Changes from Baseline Berg Balance Scale ( BBS)

    test of a person's static and dynamic balance abilities

    Measured: End of 1st week; End of 2nd week; End of 3rd week; 90 days follow-up

  5. Changes from Baseline 10 Meters Walking Test

    evaluation of functional mobility, gait, and vestibular function

    Measured: End of 1st week; End of 2nd week; End of 3rd week; 90 days follow-up

  6. Changes from Baseline Functional Ambulatory Classification (FAC)

    clinically meaningful outcome measure of mobility

    Measured: End of 1st week; End of 2nd week; End of 3rd week; 90 days follow-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Nov 2019
  2. Study start10 Oct 2019
  3. Primary completionDec 2020 (estimated)
  4. Study completionDec 2020 (estimated)

Resources

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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
The present study will be conducted in over 15 recruiting centers with a randomized double-blind design. Post-stroke patients will be randomly assigned to 3 parallel groups: Control Group (neuromotor training and sham stimulation), Experimental Group 1 (neuromotor training and cathodal tDCS over the unaffected hemisphere), Group 2 (neuromotor training and anodal tDCS over the affected hemisphere). Participants will be further partitioned on the basis of the acute/subacute and subacute/chronic stages (7-90 and 91 days from lesion onset, respectively).
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
162 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04166968
Sponsor's protocol ID
ITSTUDYTDCS-45-2019
Status last verified
Feb 2020
First submitted
13 Nov 2019
Last updated
17 Feb 2020
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A study testing Anodal transcranial direct current stimulation (A-tDCS), Cathodal transcranial direct current stimulation (C-tDCS) and Neuromotor training in people with Stroke, Ischemic and Stroke Hemorrhagic, run by IRCCS Centro San Giovanni di Dio Fatebenefratelli 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 3 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 17 Feb 2020. 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Maria Concetta Pellicciari, PhD (+39 030 3501597, studioitalianotdcs@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Changes from Baseline Fugl Meyer Assessment Scale (FMA) (time frame: End of 1st week; End of 2nd week; End of 3rd week; 90 days follow-up). 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 NCT04166968.

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 17 Feb 2020.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in