NCT02496026

Brief Summary

The objective of the study is to evaluate the effectiveness of transcranial direct current stimulation (tDCS) integrated with wrist robot-assisted treatment. In detail, the anodal stimulation on the impaired hemisphere will be used associated with a robotic treatment.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable stroke

Timeline
Completed

Started Jul 2014

Longer than P75 for not_applicable stroke

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2014

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

July 2, 2015

Completed
12 days until next milestone

First Posted

Study publicly available on registry

July 14, 2015

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 20, 2017

Completed
2 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 22, 2017

Completed
Last Updated

August 13, 2020

Status Verified

July 1, 2019

Enrollment Period

3.5 years

First QC Date

July 2, 2015

Last Update Submit

August 12, 2020

Conditions

Stroke

Outcome Measures

Primary Outcomes (1)

  • Change from Baseline in the motor impairment as assessed by the Fugl-Meyer Motor Assessment Scale (upper extremity subsection)

    Impairment level measure according to ICF

    6 weeks

Secondary Outcomes (7)

  • Change from Baseline in the motor impairment as assessed by the Fugl-Meyer Motor Assessment Scale (upper extremity subsection)

    6 months

  • Change from Baseline in the upper limb functional and motor abilities as assessed by the Motricity Index

    6 weeks

  • Change from Baseline in the upper limb functional and motor abilities as assessed by the Motricity Index

    6 months

  • Change from Baseline in the upper limb spasticity as assessed by the Modified Ashworth Scale

    6 weeks

  • Change from Baseline in the upper limb spasticity as assessed by the Modified Ashworth Scale

    6 months

  • +2 more secondary outcomes

Study Arms (2)

tDCS plus wrist robot therapy

EXPERIMENTAL

In addition to standard rehabilitation treatment Group A will perform daily sessions of wrist robot-assisted treatment in combination with tDCS (30 minutes). During first 20 min of each session the patient receives a direct current stimulation through surface sponge electrodes (35 cm2), 2 milliampere intensity: the anodal electrode is placed on presumed lesional area, the cathodal electrode is placed on the controlateral orbital bone.

Device: tDCS plus wrist robot therapy

Sham tDCS plus wrist robot therapy

SHAM COMPARATOR

Group B is treated as Group A, but tDCS, even if the cap is applied on the patient head, is not activated and no current is delivered.

Device: Sham tDCS plus wrist robot therapy

Interventions

tDCS plus wrist robot therapyDEVICE

Patients receive robotic rehabilitation session while tDCS stimulator is switched on

tDCS plus wrist robot therapy
Sham tDCS plus wrist robot therapyDEVICE

Patients receive robotic rehabilitation session while tDCS stimulator is switched off.

Sham tDCS plus wrist robot therapy

Eligibility Criteria

Age18 Years - 79 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • persons affected by first supratentorial stroke, whose onset time is 25±7 days;
  • upper limb hemiparesis;
  • cognitive and speech abilities sufficient to understand instructions and to provide informed consent;
  • absence of intense pain due to passive wrist mobilization assessed by VAS \< 3 (range 0-10);
  • ability to provide written informed consent.

You may not qualify if:

  • previous epilepsy seizures;
  • severe electroencephalographic anomalies;
  • previous neurosurgery interventions involving metallic elements placement;
  • ongoing anticonvulsant drugs treatment
  • inability to keep sitting posture;
  • severe sensory deficits;
  • general clinical complication preventing delivery of rehabilitation treatment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Auxilium Vitae Rehabilitation Centre

Volterra, 56048, Italy

Location

Related Publications (7)

  • Mehrholz J, Platz T, Kugler J, Pohl M. Electromechanical and robot-assisted arm training for improving arm function and activities of daily living after stroke. Cochrane Database Syst Rev. 2008 Oct 8;(4):CD006876. doi: 10.1002/14651858.CD006876.pub2.

    PMID: 18843735BACKGROUND

  • Floel A, Rosser N, Michka O, Knecht S, Breitenstein C. Noninvasive brain stimulation improves language learning. J Cogn Neurosci. 2008 Aug;20(8):1415-22. doi: 10.1162/jocn.2008.20098.

    PMID: 18303984BACKGROUND

  • Kang EK, Baek MJ, Kim S, Paik NJ. Non-invasive cortical stimulation improves post-stroke attention decline. Restor Neurol Neurosci. 2009;27(6):645-50. doi: 10.3233/RNN-2009-0514.

    PMID: 20042788BACKGROUND

  • Marangolo P, Marinelli CV, Bonifazi S, Fiori V, Ceravolo MG, Provinciali L, Tomaiuolo F. Electrical stimulation over the left inferior frontal gyrus (IFG) determines long-term effects in the recovery of speech apraxia in three chronic aphasics. Behav Brain Res. 2011 Dec 1;225(2):498-504. doi: 10.1016/j.bbr.2011.08.008. Epub 2011 Aug 12.

    PMID: 21856336BACKGROUND

  • Fiori V, Coccia M, Marinelli CV, Vecchi V, Bonifazi S, Ceravolo MG, Provinciali L, Tomaiuolo F, Marangolo P. Transcranial direct current stimulation improves word retrieval in healthy and nonfluent aphasic subjects. J Cogn Neurosci. 2011 Sep;23(9):2309-23. doi: 10.1162/jocn.2010.21579. Epub 2010 Oct 14.

    PMID: 20946060BACKGROUND

  • Hesse S, Waldner A, Mehrholz J, Tomelleri C, Pohl M, Werner C. Combined transcranial direct current stimulation and robot-assisted arm training in subacute stroke patients: an exploratory, randomized multicenter trial. Neurorehabil Neural Repair. 2011 Nov-Dec;25(9):838-46. doi: 10.1177/1545968311413906. Epub 2011 Aug 8.

    PMID: 21825004BACKGROUND

  • Mazzoleni S, Tran VD, Dario P, Posteraro F. Effects of Transcranial Direct Current Stimulation (tDCS) Combined With Wrist Robot-Assisted Rehabilitation on Motor Recovery in Subacute Stroke Patients: A Randomized Controlled Trial. IEEE Trans Neural Syst Rehabil Eng. 2019 Jul;27(7):1458-1466. doi: 10.1109/TNSRE.2019.2920576. Epub 2019 Jun 3.

    PMID: 31170077DERIVED

MeSH Terms

Conditions

Stroke

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeuticsConvulsive TherapyPsychiatric Somatic TherapiesBehavioral Disciplines and ActivitiesElectroshockPsychological Techniques

Study Officials

  • Federico Posteraro, MD

    Auxilium Vitae Rehabilitation Centre

    PRINCIPAL INVESTIGATOR

  • Stefano Mazzoleni, PhD

    The BioRobotics Institute, Scuola Superiore Sant'Anna

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Doctor

Study Record Dates

First Submitted

July 2, 2015

First Posted

July 14, 2015

Study Start

July 1, 2014

Primary Completion

December 20, 2017

Study Completion

December 22, 2017

Last Updated

August 13, 2020

Record last verified: 2019-07

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)