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

• Sponsor: IRCCS Centro San Giovanni di Dio Fatebenefratelli (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT04166968
• Collaborator: San Gerardo Hospital (Other), Maggiore Bellaria Hospital, Bologna (Other), Azienda Ospedaliero, Universitaria Pisana (Other), Fondazione Don Carlo Gnocchi Onlus (Other), Azienda Ospedaliera Universitaria Integrata Verona (Other), Azienda Unità Sanitaria Locale di Piacenza (Other), Azienda Ospedaliero Universitaria di Cagliari (Other), Ospedale Policlinico San Martino (Other), I.R.C.C.S. Fondazione Santa Lucia (Other), Catholic University of the Sacred Heart (Other), Istituti Clinici Zucchi (Other), Ospedali Riuniti di Foggia (Other)
• Enrollment: 162
• Location: 1
• Arms: 3
• Anticipated Duration (Months): 13.7
• Patients Per Site Per Month: 11.8

Study Details

Study Description

Brief 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 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.

Condition or Disease	Intervention/Treatment	Phase
Stroke, Ischemic; Stroke Hemorrhagic	Device: Anodal transcranial direct current stimulation (A-tDCS); Device: Cathodal transcranial direct current stimulation (C-tDCS); Device: Sham stimulation (sham-tDCS); Behavioral: Neuromotor training	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 162 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention 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).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 (Participant, Outcomes Assessor)
• Masking Description: Both participants and experimenters will be prevented from having knowledge of the assigned stimulation protocol. To do so, the investigator will create a series of numbers paired with real and sham interventions while the outcome assessor will be aware of the patient-number association only.
• Primary Purpose: Treatment
• Official Title: Multicenter Study on the Efficacy of Transcranial Direct Current Stimulation (tDCS) in Post-stroke Motor Recovery
• Actual Study Start Date: Oct 10, 2019
• Anticipated Primary Completion Date: Dec 1, 2020
• Anticipated Study Completion Date: Dec 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
Sham Comparator: Control Group neuromotor training and placebo stimulation	Device: Sham stimulation (sham-tDCS); placebo stimulation; Behavioral: Neuromotor training; conventional neuromotor treatment
Experimental: Group 1 neuromotor training and cathodal stimulation over the unaffected hemisphere	Device: Cathodal transcranial direct current stimulation (C-tDCS); Cathodal tDCS will be performed for 20 minutes over the unaffected hemisphere with an intensity set to 2 mA; Behavioral: Neuromotor training; conventional neuromotor treatment
Experimental: Group 2 neuromotor training and anodal stimulation over the affected hemisphere	Device: Anodal transcranial direct current stimulation (A-tDCS); Anodal tDCS will be performed for 20 minutes over the affected hemisphere with an intensity set to 2 mA; Behavioral: Neuromotor training; conventional neuromotor treatment

Outcome Measures

Primary Outcome Measures

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

   Performance-based assessment of sensorimotor impairment

Secondary Outcome Measures

1. Changes from Baseline Box & Block Test (B&B) [End of 1st week; End of 2nd week; End of 3rd week; 90 days follow-up]

   test for manual dexterity of upper extremity function

2. Changes from Baseline Barthel Index (BI) [End of 1st week; End of 2nd week; End of 3rd week; 90 days follow-up]

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

3. Changes from Baseline Trunk Control Test (TCT) [End of 1st week; End of 2nd week; End of 3rd week; 90 days follow-up]

   assessment of the deteriorations in trunk control

4. Changes from Baseline Berg Balance Scale ( BBS) [End of 1st week; End of 2nd week; End of 3rd week; 90 days follow-up]

   test of a person's static and dynamic balance abilities

5. Changes from Baseline 10 Meters Walking Test [End of 1st week; End of 2nd week; End of 3rd week; 90 days follow-up]

   evaluation of functional mobility, gait, and vestibular function

6. Changes from Baseline Functional Ambulatory Classification (FAC) [End of 1st week; End of 2nd week; End of 3rd week; 90 days follow-up]

   clinically meaningful outcome measure of mobility

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 90 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• First-ever ischemic stroke

• Red or white stroke

• Barthel Index > 90 before lesion onset

Exclusion Criteria:

• 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	IRCCS Centro San Giovanni di Dio Fatebenefratelli	Brescia	Lombardia	Italy	25125

Sponsors and Collaborators

• IRCCS Centro San Giovanni di Dio Fatebenefratelli
• San Gerardo Hospital
• Maggiore Bellaria Hospital, Bologna
• Azienda Ospedaliero, Universitaria Pisana
• Fondazione Don Carlo Gnocchi Onlus
• Azienda Ospedaliera Universitaria Integrata Verona
• Azienda Unità Sanitaria Locale di Piacenza
• Azienda Ospedaliero Universitaria di Cagliari
• Ospedale Policlinico San Martino
• I.R.C.C.S. Fondazione Santa Lucia
• Catholic University of the Sacred Heart
• Istituti Clinici Zucchi
• Ospedali Riuniti di Foggia

Investigators

• Principal Investigator: Carlo Miniussi, PhD, IRCCS Centro San Giovanni di Dio Fatebenefratelli

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Carlo Miniussi, Professor, PhD, IRCCS Centro San Giovanni di Dio Fatebenefratelli
• ClinicalTrials.gov Identifier: NCT04166968
• Other Study ID Numbers: ITSTUDYTDCS-45-2019
• First Posted: Nov 18, 2019
• Last Update Posted: Feb 17, 2020
• Last Verified: Feb 1, 2020

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Carlo Miniussi, Professor, PhD, IRCCS Centro San Giovanni di Dio Fatebenefratelli: transcranial direct current stimulation; stroke rehabilitation
• Additional relevant MeSH terms: Stroke; Ischemic Stroke; Hemorrhagic Stroke

Study Results

No Results Posted as of Feb 17, 2020