StrokeNCT02496026
Transcranial Direct Current Stimulation and Robotic Therapy in Upper Limb Motor Recovery After Stroke
A study testing tDCS plus wrist robot therapy in people with Stroke, run by Auxilium Vitae Volterra at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Ages 18 to 79 years
- Conditions the study is for
- Stroke
- What is being tested?
- tDCS plus wrist robot therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteItaly
- Study dates
- Jul 2014to 22 Dec 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Stroke
- Being tested
- tDCS plus wrist robot therapy, Sham tDCS plus wrist robot therapy
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tDCS plus wrist robot therapyDevice
Patients receive robotic rehabilitation session while tDCS stimulator is switched on
Sham tDCS plus wrist robot therapyDevice
Patients receive robotic rehabilitation session while tDCS stimulator is switched off.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Sham tDCS plus wrist robot therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 weeks
Secondary outcomes (7)
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
Measured: 6 months
Change from Baseline in the upper limb functional and motor abilities as assessed by the Motricity Index
Impairment level measure according to ICF
Measured: 6 weeks
Change from Baseline in the upper limb functional and motor abilities as assessed by the Motricity Index
Impairment level measure according to ICF
Measured: 6 months
Change from Baseline in the upper limb spasticity as assessed by the Modified Ashworth Scale
Impairment level measure according to ICF
Measured: 6 weeks
Change from Baseline in the upper limb spasticity as assessed by the Modified Ashworth Scale
Impairment level measure according to ICF
Measured: 6 months
Change from Baseline in the unilateral gross manual dexterity as assessed by the Block and Box test
Activities level measure according to ICF
Measured: 6 weeks
Change from Baseline in the unilateral gross manual dexterity as assessed by the Block and Box test
Activities level measure according to ICF
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2015 (estimated)
- Study startJul 2014
- Primary completion20 Dec 2017
- Study completion22 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Auxilium Vitae Volterra
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, federico posteraro, Auxilium Vitae Volterra
- Investigators
- Federico Posteraro, MD, Principal investigator, Auxilium Vitae Rehabilitation CentreStefano Mazzoleni, PhD, Study director, The BioRobotics Institute, Scuola Superiore Sant'Anna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02496026
- Sponsor's protocol ID
- RN20141
- Status last verified
- Jul 2019
- First submitted
- 2 Jul 2015
- Last updated
- 13 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 18843735Floel 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.
PubMed 18303984Kang 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.
PubMed 20042788Marangolo 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.
PubMed 21856336Fiori 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.
PubMed 20946060Hesse 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.
PubMed 21825004Mazzoleni 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.
PubMed 31170077
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcranial Direct Current Stimulation and Robotic Therapy in Upper Limb Motor Recovery After Stroke
- ClinicalTrials.gov ID
- NCT02496026
- Acronym / sponsor ID
- RN20141
- Conditions
- Stroke
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Auxilium Vitae VolterraUniversity, hospital or other
- Study start
- Jul 2014
- Primary completion
- 20 Dec 2017 (actual)
- Study completion
- 22 Dec 2017 (actual)
- First posted
- 14 Jul 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| tDCS plus wrist robot therapy | Experimental | Device: tDCS plus wrist robot therapyIn 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. |
| Sham tDCS plus wrist robot therapy | Sham comparator | Device: Sham tDCS plus wrist robot therapyGroup 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. |
Who may qualify
- Ages
- 18 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (7 listed)
- previous epilepsy seizures;
- severe electroencephalographic anomalies;
- previous neurosurgery interventions involving metallic elements placement;
- ongoing anticonvulsant drugs treatment
- inability to keep sitting posture;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| tDCS plus wrist robot therapyPatients receive robotic rehabilitation session while tDCS stimulator is switched on | Device | tDCS plus wrist robot therapy |
| Sham tDCS plus wrist robot therapyPatients receive robotic rehabilitation session while tDCS stimulator is switched off. | Device | Sham tDCS plus wrist robot therapy |
Primary outcome
Change from Baseline in the motor impairment as assessed by the Fugl-Meyer Motor Assessment Scale (upper extremity subsection)
Time frame: 6 weeks
Impairment level measure according to ICF
7 secondary outcomes
Change from Baseline in the motor impairment as assessed by the Fugl-Meyer Motor Assessment Scale (upper extremity subsection)
Time frame: 6 months
Change from Baseline in the upper limb functional and motor abilities as assessed by the Motricity Index
Time frame: 6 weeks
Change from Baseline in the upper limb functional and motor abilities as assessed by the Motricity Index
Time frame: 6 months
Change from Baseline in the upper limb spasticity as assessed by the Modified Ashworth Scale
Time frame: 6 weeks
Change from Baseline in the upper limb spasticity as assessed by the Modified Ashworth Scale
Time frame: 6 months
Change from Baseline in the unilateral gross manual dexterity as assessed by the Block and Box test
Time frame: 6 weeks
Change from Baseline in the unilateral gross manual dexterity as assessed by the Block and Box test
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2020.
- Background: PubMed 18843735Mehrholz 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.
- Background: PubMed 18303984Floel 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.
- Background: PubMed 20042788Kang 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.
- Background: PubMed 21856336Marangolo 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.
- Background: PubMed 20946060Fiori 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.
- Background: PubMed 21825004Hesse 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.
- Derived from this study: PubMed 31170077Mazzoleni 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Federico Posteraro, MD principal investigator
Auxilium Vitae Rehabilitation Centre
Stefano Mazzoleni, PhD study director
The BioRobotics Institute, Scuola Superiore Sant'Anna
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing tDCS plus wrist robot therapy in people with Stroke, run by Auxilium Vitae Volterra at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in the motor impairment as assessed by the Fugl-Meyer Motor Assessment Scale (upper extremity subsection) (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02496026, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2020.