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

NCT04166968 | Unknown DMC

• 1 other identifier: ITSTUDYTDCS-45-2019
• Study Type: interventional
• Target: 162
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke, Ischemic; Stroke Hemorrhagic

Keywords

transcranial direct current stimulation; stroke rehabilitation

Outcome Measures

Primary Outcomes (1)

• Changes from Baseline Fugl Meyer Assessment Scale (FMA)

  Performance-based assessment of sensorimotor impairment

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

Secondary Outcomes (6)

• Changes from Baseline Box & Block Test (B&B)

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

• Changes from Baseline Barthel Index (BI)

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

• Changes from Baseline Trunk Control Test (TCT)

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

• Changes from Baseline Berg Balance Scale ( BBS)

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

• Changes from Baseline 10 Meters Walking Test

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

Study Arms (3)

Control Group

SHAM COMPARATOR

neuromotor training and placebo stimulation

Device: Sham stimulation (sham-tDCS); Behavioral: Neuromotor training

Group 1

EXPERIMENTAL

neuromotor training and cathodal stimulation over the unaffected hemisphere

Device: Cathodal transcranial direct current stimulation (C-tDCS); Behavioral: Neuromotor training

Group 2

EXPERIMENTAL

neuromotor training and anodal stimulation over the affected hemisphere

Device: Anodal transcranial direct current stimulation (A-tDCS); Behavioral: Neuromotor training

Interventions

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

Group 2

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

Group 1

Sham stimulation (sham-tDCS) DEVICE

placebo stimulation

Control Group

Neuromotor training BEHAVIORAL

conventional neuromotor treatment

Control Group; Group 1; Group 2

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

IRCCS Centro San Giovanni di Dio Fatebenefratelli

Brescia, Lombardy, 25125, Italy

RECRUITING

MeSH Terms

Conditions

Ischemic Stroke; Hemorrhagic Stroke

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Study Officials

• Carlo Miniussi, PhD

  IRCCS Centro San Giovanni di Dio Fatebenefratelli

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Maria Concetta Pellicciari, PhD

CONTACT

+39 030 3501597; studioitalianotdcs@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, PhD

Model Details: 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).

Study Record Dates

• First Submitted: November 13, 2019
• First Posted: November 18, 2019
• Study Start: October 10, 2019
• Primary Completion: December 1, 2020
• Study Completion: December 1, 2020
• Last Updated: February 17, 2020

Record last verified: 2020-02

Locations

IT (1)