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Transcranial Direct Current Stimulation and Robotic Therapy in Upper Limb Motor Recovery After Stroke

Primary Purpose

Stroke

Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
tDCS plus wrist robot therapy
Sham tDCS plus wrist robot therapy
Sponsored by
Auxilium Vitae Volterra
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke

Eligibility Criteria

18 Years - 79 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

  • Auxilium Vitae Rehabilitation Centre

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

tDCS plus wrist robot therapy

Sham tDCS plus wrist robot therapy

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
Change from Baseline in the upper limb functional and motor abilities as assessed by the Motricity Index
Impairment level measure according to ICF
Change from Baseline in the upper limb functional and motor abilities as assessed by the Motricity Index
Impairment level measure according to ICF
Change from Baseline in the upper limb spasticity as assessed by the Modified Ashworth Scale
Impairment level measure according to ICF
Change from Baseline in the upper limb spasticity as assessed by the Modified Ashworth Scale
Impairment level measure according to ICF
Change from Baseline in the unilateral gross manual dexterity as assessed by the Block and Box test
Activities level measure according to ICF
Change from Baseline in the unilateral gross manual dexterity as assessed by the Block and Box test
Activities level measure according to ICF

Full Information

First Posted
July 2, 2015
Last Updated
August 12, 2020
Sponsor
Auxilium Vitae Volterra
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1. Study Identification

Unique Protocol Identification Number
NCT02496026
Brief Title
Transcranial Direct Current Stimulation and Robotic Therapy in Upper Limb Motor Recovery After Stroke
Official Title
Transcranial Direct Current Stimulation and Robotic Therapy in Upper Limb Motor Recovery After Stroke
Study Type
Interventional

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
July 2014 (undefined)
Primary Completion Date
December 20, 2017 (Actual)
Study Completion Date
December 22, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Auxilium Vitae Volterra

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
As for transcranial direct current stimulation a HDC kit (ATES/EB NEURO, Firenze, Italy) will be used as device. It is a new device generation of stimulator able to provide an effective stimulation pattern. As robotic device the InMotion wrist robot (Interactive Motion Technologies Inc., Watertown, MA, USA) will be used. It is an end-effector robotic device able to assist as needed the wrist movements.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
tDCS plus wrist robot therapy
Arm Type
Experimental
Arm Description
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.
Arm Title
Sham tDCS plus wrist robot therapy
Arm Type
Sham Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
tDCS plus wrist robot therapy
Intervention Description
Patients receive robotic rehabilitation session while tDCS stimulator is switched on
Intervention Type
Device
Intervention Name(s)
Sham tDCS plus wrist robot therapy
Intervention Description
Patients receive robotic rehabilitation session while tDCS stimulator is switched off.
Primary Outcome Measure Information:
Title
Change from Baseline in the motor impairment as assessed by the Fugl-Meyer Motor Assessment Scale (upper extremity subsection)
Description
Impairment level measure according to ICF
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Change from Baseline in the motor impairment as assessed by the Fugl-Meyer Motor Assessment Scale (upper extremity subsection)
Description
Impairment level measure according to ICF
Time Frame
6 months
Title
Change from Baseline in the upper limb functional and motor abilities as assessed by the Motricity Index
Description
Impairment level measure according to ICF
Time Frame
6 weeks
Title
Change from Baseline in the upper limb functional and motor abilities as assessed by the Motricity Index
Description
Impairment level measure according to ICF
Time Frame
6 months
Title
Change from Baseline in the upper limb spasticity as assessed by the Modified Ashworth Scale
Description
Impairment level measure according to ICF
Time Frame
6 weeks
Title
Change from Baseline in the upper limb spasticity as assessed by the Modified Ashworth Scale
Description
Impairment level measure according to ICF
Time Frame
6 months
Title
Change from Baseline in the unilateral gross manual dexterity as assessed by the Block and Box test
Description
Activities level measure according to ICF
Time Frame
6 weeks
Title
Change from Baseline in the unilateral gross manual dexterity as assessed by the Block and Box test
Description
Activities level measure according to ICF
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Federico Posteraro, MD
Organizational Affiliation
Auxilium Vitae Rehabilitation Centre
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Stefano Mazzoleni, PhD
Organizational Affiliation
The BioRobotics Institute, Scuola Superiore Sant'Anna
Official's Role
Study Director
Facility Information:
Facility Name
Auxilium Vitae Rehabilitation Centre
City
Volterra
ZIP/Postal Code
56048
Country
Italy

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
18843735
Citation
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.
Results Reference
background
PubMed Identifier
18303984
Citation
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.
Results Reference
background
PubMed Identifier
20042788
Citation
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.
Results Reference
background
PubMed Identifier
21856336
Citation
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.
Results Reference
background
PubMed Identifier
20946060
Citation
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.
Results Reference
background
PubMed Identifier
21825004
Citation
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.
Results Reference
background
PubMed Identifier
31170077
Citation
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.
Results Reference
derived

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Transcranial Direct Current Stimulation and Robotic Therapy in Upper Limb Motor Recovery After Stroke

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