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

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02496026
• Other study ID #: RN20141
• Status: Completed
• Phase: N/A
• Start date: July 2014
• Est. completion date: December 22, 2017

Study information

• Verified date: July 2019
• Source: Auxilium Vitae Volterra
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: December 22, 2017
• Est. primary completion date: December 20, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 79 Years

Eligibility

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.

Related Conditions & MeSH terms

• Stroke

Intervention

Device:
• tDCS plus wrist robot therapy
Patients receive robotic rehabilitation session while tDCS stimulator is switched on
• Sham tDCS plus wrist robot therapy
Patients receive robotic rehabilitation session while tDCS stimulator is switched off.

Locations

Country	Name	City	State
Italy	Auxilium Vitae Rehabilitation Centre	Volterra

Sponsors (1)

Lead Sponsor	Collaborator
Auxilium Vitae Volterra

Country where clinical trial is conducted

Italy, 

References & Publications (6)

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. — View Citation

Flöel A, Rösser 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. — View 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. — View 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. — View 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. — View 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. Review. Update in: Cochrane Database Syst Rev. 2012;6:CD006876. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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 months
Secondary	Change from Baseline in the upper limb functional and motor abilities as assessed by the Motricity Index	Impairment level measure according to ICF	6 weeks
Secondary	Change from Baseline in the upper limb functional and motor abilities as assessed by the Motricity Index	Impairment level measure according to ICF	6 months
Secondary	Change from Baseline in the upper limb spasticity as assessed by the Modified Ashworth Scale	Impairment level measure according to ICF	6 weeks
Secondary	Change from Baseline in the upper limb spasticity as assessed by the Modified Ashworth Scale	Impairment level measure according to ICF	6 months
Secondary	Change from Baseline in the unilateral gross manual dexterity as assessed by the Block and Box test	Activities level measure according to ICF	6 weeks
Secondary	Change from Baseline in the unilateral gross manual dexterity as assessed by the Block and Box test	Activities level measure according to ICF	6 months