Clinical trial NCT02496026: 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
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Lead sponsor: Auxilium Vitae Volterra
Sponsor class: OTHER
First posted: 2015-07-14
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change from Baseline in the motor impairment as assessed by the Fugl-Meyer Motor Assessment Scale (upper extremity subsection)
timeFrame: 6 weeks
Secondary outcomes:
measure: Change from Baseline in the motor impairment as assessed by the Fugl-Meyer Motor Assessment Scale (upper extremity subsection)
timeFrame: 6 months
measure: Change from Baseline in the upper limb functional and motor abilities as assessed by the Motricity Index
timeFrame: 6 weeks
measure: Change from Baseline in the upper limb functional and motor abilities as assessed by the Motricity Index
timeFrame: 6 months
measure: Change from Baseline in the upper limb spasticity as assessed by the Modified Ashworth Scale
timeFrame: 6 weeks
measure: Change from Baseline in the upper limb spasticity as assessed by the Modified Ashworth Scale
timeFrame: 6 months
measure: Change from Baseline in the unilateral gross manual dexterity as assessed by the Block and Box test
timeFrame: 6 weeks
measure: Change from Baseline in the unilateral gross manual dexterity as assessed by the Block and Box test
timeFrame: 6 months
Other outcomes:
Locations:
city: Volterra
country: Italy
facility: Auxilium Vitae Rehabilitation Centre
Study officials:
affiliation: Auxilium Vitae Rehabilitation Centre
name: Federico Posteraro, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: The BioRobotics Institute, Scuola Superiore Sant'Anna
name: Stefano Mazzoleni, PhD
role: STUDY_DIRECTOR
References:
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.
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.
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.
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.
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.
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.
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.