StrokeCCS&RATNCT05478434
Cortico-cortical Stimulation and Robot-assisted Therapy for Upper Limb Recovery After Stroke (CCS&RAT)
A study testing Cortico-cortical stimulation plus robot-assisted therapy in people with Stroke and Stroke, Ischemic, run by I.R.C.C.S. Fondazione Santa Lucia at 1 site in Italy.
Trial summary
The purpose of this study is to tested the effect of combination of a paired associative stimulation of two functional interconnected areas of the cerebral cortex (posterior-parietal cortex and primary motor cortex) with robot-assisted therapy in the recovery of upper limb after stroke. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Stroke, Stroke, Ischemic
- What is being tested?
- Cortico-cortical stimulation plus robot-assisted therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteItaly
- Study dates
- 21 Aug 2022to Oct 2025
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- first ever chronic ischemic stroke;
- hemiparesis due to left or right subcortical or cortical lesion in the territory of the middle cerebral artery;
- severe or moderate residual upper limb impairment (FMA < 52 in the motor domain A/D)
Who cannot join
- history of seizures;
- severe general impairment or concomitant diseases;
- treatment with benzodiazepines, baclofen, and antidepressants;
- Intracranial metal implants;
- cardiac pacemaker;
- pregnancy status;
Show all 10Show fewer
- orthopedic contraindications for upper limb;
- upper limb pain;
- cognitive impairment (MMSE < 23);
- presence of unilateral spatial neglect
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Santa Lucia Foundation
Rome, 00179
Sonia Bonnì, PhD, +390651501181, s.bonni@hsantalucia.it
Giuseppe Vannozzi, Prof
About this study
Official title: Cortico-cortical Stimulation and Robot-assisted Therapy a New Approach of Upper Limb Functional Recovery After Stroke
The purpose of this study is to tested the effect of combination of a paired associative stimulation of two functional interconnected areas of the cerebral cortex (posterior-parietal cortex and primary motor cortex) with robot-assisted therapy in the recovery of upper limb after stroke.
Read the detailed description
BACKGROUND
Stroke survivors reported upper limb impairment that contribute to reducing the overall quality of life, social participation and professional activities. The impairment of the upper limb is due to motor and sensory alteration that could compromise the sensorimotor integration. The posterior parietal cortex (PPC) is a potential circuit where this integration could occur during active somatosensation. Indeed, PPC is a site of massive confluence of visual, tactile, proprioceptive, and vestibular signals. This area may be involved in transforming information about the location of targets in space, into signals related to motor intentions. This process likely occurs through parietal-motor connections, which are known to be involved in the transfer of relevant sensitive information for planning, reaching, and grasping. Paired associative stimulation (PAS) of PPC and primary motor area (M1), by means of bi-focal trans-cranial magnetic stimulation, can modulate M1 excitability. This information reinforces the hypothesis that modulation of PPC-M1 connectivity can be used as a new approach to modify motor excitability and sensorimotor interaction. Parallel, robot assisted training (RAT) can induce a plastic reorganization at the muscular afferents, spinal motor neurons, interneuron system and beyond and facilitates neural plasticity and motor relearning through goal-oriented training. The robotics device allows to train patients in an intensive, task-oriented, and top-down therapy way, increasing patients' compliance and motivation. The cognitive top-down stimulation is allowed by means of the introduction of visual feedback performed through exergaming. Recently, it has been proposed the development of new intervention strategies that combine neurostimulation of a target brain area with neurorehabilitation, such as physical therapy or virtual reality. Although both TMS and RAT have shown individually promising effects in upper limb recovery after a stroke, their combination has not been tested to date.
AIMS
- To determine whether robot-assisted therapy combined with cortico-cortical non-invasive stimulation of M1 and PPC areas can improve functional recovery of upper extremity in patients with hemiparesis due to stroke.
- To evaluate the feasibility of robot-assisted training exergaming technology for reaching and grasping training for stroke rehabilitation.
- To investigate the neurophysiological changes in PPC-M1 connectivity (through TMS EEG) to clarify the effectiveness of PAS on neuromodulation of the PPC-M1 network.
- Conditions
- Stroke, Stroke, Ischemic
- Being tested
- Cortico-cortical stimulation plus robot-assisted therapy, Sham cortico-cortical stimulation plus robot-assisted therapy
- Keywords
- Stroke, Transcranial Magnetic Stimulation, Robot-assisted Therapy
- Medical subject headings
- Stroke, Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cortico-cortical stimulation plus robot-assisted therapyDevice
15 sessions of cortico-cortical stimulation between the PPC and the M1 of the lesioned hemisphere and robot-assisted therapy. Paired-pulse stimulation (PAS) technique, with 5ms inter-stimulus time between the two areas (PPC to M1), will be done through two high-power Magstim 200 machines (Magstim® Rapid²). To stimulate the M1 area, the coil will be placed tangentially to the scalp at a 45° angle to the midline, to stimulate the PPC area the center of the coil will be positioned over P4 (10-20 EEG system) tangentially to the skull with the handle pointing downward and slightly medial (10°). Robot-assisted therapy will be performed with an Armeo® Power II (Hocoma), an integrative system composed by a robotic exoskeleton device connected to a laptop for the audio-visual biofeedback for the upper limb therapy.
Sham cortico-cortical stimulation plus robot-assisted therapyDevice
15 sessions of sham cortico-cortical stimulation between the PPC and the M1 of the lesioned hemisphere and robot-assisted therapy. Sham paired-pulse stimulation (PAS) will be done through two high-power Magstim 200 machines (Magstim® Rapid²). To simulate the real stimulation, the coils will placed in the same sites with different inclination respect to the scalp (90°). Robot-assisted therapy will be performed with an Armeo® Power II (Hocoma), an integrative system composed by a robotic exoskeleton device connected to a laptop for the audio-visual biofeedback for the upper limb therapy.
| Study group | Role | What they receive |
|---|---|---|
| Robot and stimulation PPC-M1 | Experimental | Combined paired pulse stimulation (PAS) with robot-assisted therapy Receives: Device: Cortico-cortical stimulation plus robot-assisted therapy |
| Robot and sham stimulation PPC-M1 | Sham comparator | Combined sham PAS with robot-assisted therapy Receives: Device: Sham cortico-cortical stimulation plus robot-assisted therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the Fugl-Meyer Assessment Scale for Upper Extremity (FMA-UE)
Comprehensive clinical measurement tool of upper limb functions after stroke. Range score form 0 to 66 points, a higher score represents an improvement.
Measured: baseline; 3weeks (end of treatment); 7weeks (follow-up)
Secondary outcomes (6)
Change in the Box and Block Test
Clinical test of motor function of upper limb after stroke.
Measured: baseline; 3weeks (end of treatment); 7weeks (follow-up)
Change in the Modified Ashworth Scale
Clinical Scale used to assessed spasticity. Range score from 0 to 5, a lower score represents an improvement.
Measured: baseline; 3weeks (end of treatment); 7weeks (follow-up)
Change in the functional movements of upper limb
Change in the kinematics variables will be recorded via inertial measurement units and motion-analysis during a three-reaching tasks and the Box-and-Block test.
Measured: baseline; 3weeks (end of treatment); 7weeks (follow-up)
Change in the cortical excitability
Stimulating a specific area with a single pulse of TMS evoke a so called Transcranial Evoked Potential (TEP), which is a well-know index of cortical excitability of the stimulated cortical area .
Measured: baseline; 3weeks (end of treatment); 7weeks (follow-up)
Change in the cortical oscillations
From TMS-EEG recording it is possible to analyze oscillatory activity of the stimulated brain area. Monitoring the frequency band during time after TMS-pulse we calculate Time-frequency Wavelets and from there the TMS-related spectral perturbation (TRSP) as output of the frequency bands (Delta, Theta, Alpha, Beta, Gamma) expressed.
Measured: baseline; 3weeks (end of treatment); 7weeks (follow-up)
Change in the cortical connectivity
Monitoring how TMS-pulse spreads from the stimulated area to the other areas, it is possible to assess the effective connectivity that area has with a widespread of network connected. So we calculate the Coherence between different areas and other connectivity indexes in the cortical oscillatory domain, i.e. Phase-locking Value (PLV) and Phase-amplitude coupling (PAC)
Measured: baseline; 3weeks (end of treatment); 7weeks (follow-up)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2022
- Study start21 Aug 2022
- Primary completionAug 2025 (estimated)
- Study completionOct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)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
- Model description
- Randomised Clinical trial
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- I.R.C.C.S. Fondazione Santa Lucia
- Sponsor type
- University, hospital or other
- Collaborators
- Università degli studi di Roma Foro Italico
- Responsible party
- Sponsor
- Investigators
- Giacomo Koch, prof., Principal investigator, IRCCS Santa Lucia Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05478434
- Sponsor's protocol ID
- PROG.910
- Acronym
- CCS&RAT
- Status last verified
- May 2024
- First submitted
- 6 Jul 2022
- Last updated
- 20 Feb 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hatem SM, Saussez G, Della Faille M, Prist V, Zhang X, Dispa D, Bleyenheuft Y. Rehabilitation of Motor Function after Stroke: A Multiple Systematic Review Focused on Techniques to Stimulate Upper Extremity Recovery. Front Hum Neurosci. 2016 Sep 13;10:442. doi: 10.3389/fnhum.2016.00442. eCollection 2016.
PubMed 27679565Mohan H, de Haan R, Mansvelder HD, de Kock CPJ. The posterior parietal cortex as integrative hub for whisker sensorimotor information. Neuroscience. 2018 Jan 1;368:240-245. doi: 10.1016/j.neuroscience.2017.06.020. Epub 2017 Jun 19.
PubMed 28642168Winstein CJ, Stein J, Arena R, Bates B, Cherney LR, Cramer SC, Deruyter F, Eng JJ, Fisher B, Harvey RL, Lang CE, MacKay-Lyons M, Ottenbacher KJ, Pugh S, Reeves MJ, Richards LG, Stiers W, Zorowitz RD; American Heart Association Stroke Council, Council on Cardiovascular and Stroke Nursing, Council on Clinical Cardiology, and Council on Quality of Care and Outcomes Research. Guidelines for Adult Stroke Rehabilitation and Recovery: A Guideline for Healthcare Professionals From the American Heart Association/American Stroke Association. Stroke. 2016 Jun;47(6):e98-e169. doi: 10.1161/STR.0000000000000098. Epub 2016 May 4.
PubMed 27145936Koch G, Fernandez Del Olmo M, Cheeran B, Schippling S, Caltagirone C, Driver J, Rothwell JC. Functional interplay between posterior parietal and ipsilateral motor cortex revealed by twin-coil transcranial magnetic stimulation during reach planning toward contralateral space. J Neurosci. 2008 Jun 4;28(23):5944-53. doi: 10.1523/JNEUROSCI.0957-08.2008.
PubMed 18524898Reti IM. Brain Stimulation: Methodologies and Interventions. John Wiley & Sons. 2015
Veniero D, Ponzo V, Koch G. Paired associative stimulation enforces the communication between interconnected areas. J Neurosci. 2013 Aug 21;33(34):13773-83. doi: 10.1523/JNEUROSCI.1777-13.2013.
PubMed 23966698Chao CC, Karabanov AN, Paine R, Carolina de Campos A, Kukke SN, Wu T, Wang H, Hallett M. Induction of motor associative plasticity in the posterior parietal cortex-primary motor network. Cereb Cortex. 2015 Feb;25(2):365-73. doi: 10.1093/cercor/bht230. Epub 2013 Aug 22.
PubMed 23968834Kwakkel G, Kollen BJ, Krebs HI. Effects of robot-assisted therapy on upper limb recovery after stroke: a systematic review. Neurorehabil Neural Repair. 2008 Mar-Apr;22(2):111-21. doi: 10.1177/1545968307305457. Epub 2007 Sep 17.
PubMed 17876068Morone G, Spitoni GF, De Bartolo D, Ghanbari Ghooshchy S, Di Iulio F, Paolucci S, Zoccolotti P, Iosa M. Rehabilitative devices for a top-down approach. Expert Rev Med Devices. 2019 Mar;16(3):187-195. doi: 10.1080/17434440.2019.1574567. Epub 2019 Feb 6.
PubMed 30677307Koch G, Bonni S, Casula EP, Iosa M, Paolucci S, Pellicciari MC, Cinnera AM, Ponzo V, Maiella M, Picazio S, Sallustio F, Caltagirone C. Effect of Cerebellar Stimulation on Gait and Balance Recovery in Patients With Hemiparetic Stroke: A Randomized Clinical Trial. JAMA Neurol. 2019 Feb 1;76(2):170-178. doi: 10.1001/jamaneurol.2018.3639.
PubMed 30476999Chen YJ, Huang YZ, Chen CY, Chen CL, Chen HC, Wu CY, Lin KC, Chang TL. Intermittent theta burst stimulation enhances upper limb motor function in patients with chronic stroke: a pilot randomized controlled trial. BMC Neurol. 2019 Apr 25;19(1):69. doi: 10.1186/s12883-019-1302-x.
PubMed 31023258Palermo E, Hayes DR, Russo EF, Calabro RS, Pacilli A, Filoni S. Translational effects of robot-mediated therapy in subacute stroke patients: an experimental evaluation of upper limb motor recovery. PeerJ. 2018 Sep 4;6:e5544. doi: 10.7717/peerj.5544. eCollection 2018.
PubMed 30202655Cinnera AM, Bonni S, D'Acunto A, Maiella M, Ferraresi M, Casula EP, Pezzopane V, Tramontano M, Iosa M, Paolucci S, Morone G, Vannozzi G, Koch G. Cortico-cortical stimulation and robot-assisted therapy (CCS and RAT) for upper limb recovery after stroke: study protocol for a randomised controlled trial. Trials. 2023 Dec 21;24(1):823. doi: 10.1186/s13063-023-07849-1.
PubMed 38129910
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cortico-cortical Stimulation and Robot-assisted Therapy a New Approach of Upper Limb Functional Recovery After Stroke
- ClinicalTrials.gov ID
- NCT05478434
- Acronym / sponsor ID
- CCS&RAT / PROG.910
- Conditions
- Stroke, Stroke, Ischemic
- Keywords
- Stroke, Transcranial Magnetic Stimulation, Robot-assisted Therapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- I.R.C.C.S. Fondazione Santa LuciaUniversity, hospital or other
- Collaborators
- Università degli studi di Roma Foro Italico
- Study start
- 21 Aug 2022 (actual)
- Primary completion
- Aug 2025 (estimated)
- Study completion
- Oct 2025 (estimated)
- First posted
- 28 Jul 2022 (actual)
- 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 purpose of this study is to tested the effect of combination of a paired associative stimulation of two functional interconnected areas of the cerebral cortex (posterior-parietal cortex and primary motor cortex) with robot-assisted therapy in the recovery of upper limb after stroke.
Detailed description
BACKGROUND
Stroke survivors reported upper limb impairment that contribute to reducing the overall quality of life, social participation and professional activities. The impairment of the upper limb is due to motor and sensory alteration that could compromise the sensorimotor integration. The posterior parietal cortex (PPC) is a potential circuit where this integration could occur during active somatosensation. Indeed, PPC is a site of massive confluence of visual, tactile, proprioceptive, and vestibular signals. This area may be involved in transforming information about the location of targets in space, into signals related to motor intentions. This process likely occurs through parietal-motor connections, which are known to be involved in the transfer of relevant sensitive information for planning, reaching, and grasping. Paired associative stimulation (PAS) of PPC and primary motor area (M1), by means of bi-focal trans-cranial magnetic stimulation, can modulate M1 excitability. This information reinforces the hypothesis that modulation of PPC-M1 connectivity can be used as a new approach to modify motor excitability and sensorimotor interaction. Parallel, robot assisted training (RAT) can induce a plastic reorganization at the muscular afferents, spinal motor neurons, interneuron system and beyond and facilitates neural plasticity and motor relearning through goal-oriented training. The robotics device allows to train patients in an intensive, task-oriented, and top-down therapy way, increasing patients' compliance and motivation. The cognitive top-down stimulation is allowed by means of the introduction of visual feedback performed through exergaming. Recently, it has been proposed the development of new intervention strategies that combine neurostimulation of a target brain area with neurorehabilitation, such as physical therapy or virtual reality. Although both TMS and RAT have shown individually promising effects in upper limb recovery after a stroke, their combination has not been tested to date.
AIMS
- To determine whether robot-assisted therapy combined with cortico-cortical non-invasive stimulation of M1 and PPC areas can improve functional recovery of upper extremity in patients with hemiparesis due to stroke.
- To evaluate the feasibility of robot-assisted training exergaming technology for reaching and grasping training for stroke rehabilitation.
- To investigate the neurophysiological changes in PPC-M1 connectivity (through TMS EEG) to clarify the effectiveness of PAS on neuromodulation of the PPC-M1 network.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomised Clinical trial
| Arm | Type | Receives |
|---|---|---|
| Robot and stimulation PPC-M1 | Experimental | Device: Cortico-cortical stimulation plus robot-assisted therapyCombined paired pulse stimulation (PAS) with robot-assisted therapy |
| Robot and sham stimulation PPC-M1 | Sham comparator | Device: Sham cortico-cortical stimulation plus robot-assisted therapyCombined sham PAS with robot-assisted therapy |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- first ever chronic ischemic stroke;
- hemiparesis due to left or right subcortical or cortical lesion in the territory of the middle cerebral artery;
- severe or moderate residual upper limb impairment (FMA < 52 in the motor domain A/D)
Key exclusion criteria (10 listed)
- history of seizures;
- severe general impairment or concomitant diseases;
- treatment with benzodiazepines, baclofen, and antidepressants;
- Intracranial metal implants;
- cardiac pacemaker;
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 |
|---|---|---|
| Cortico-cortical stimulation plus robot-assisted therapy15 sessions of cortico-cortical stimulation between the PPC and the M1 of the lesioned hemisphere and robot-assisted therapy. Paired-pulse stimulation (PAS) technique, with 5ms inter-stimulus time between the two areas (PPC to M1), will be done through two high-power Magstim 200 machines (Magstim® Rapid²). To stimulate the M1 area, the coil will be placed tangentially to the scalp at a 45° angle to the midline, to stimulate the PPC area the center of the coil will be positioned over P4 (10-20 EEG system) tangentially to the skull with the handle pointing downward and slightly medial (10°). Robot-assisted therapy will be performed with an Armeo® Power II (Hocoma), an integrative system composed by a robotic exoskeleton device connected to a laptop for the audio-visual biofeedback for the upper limb therapy. | Device | Robot and stimulation PPC-M1 |
| Sham cortico-cortical stimulation plus robot-assisted therapy15 sessions of sham cortico-cortical stimulation between the PPC and the M1 of the lesioned hemisphere and robot-assisted therapy. Sham paired-pulse stimulation (PAS) will be done through two high-power Magstim 200 machines (Magstim® Rapid²). To simulate the real stimulation, the coils will placed in the same sites with different inclination respect to the scalp (90°). Robot-assisted therapy will be performed with an Armeo® Power II (Hocoma), an integrative system composed by a robotic exoskeleton device connected to a laptop for the audio-visual biofeedback for the upper limb therapy. | Device | Robot and sham stimulation PPC-M1 |
Primary outcome
Change in the Fugl-Meyer Assessment Scale for Upper Extremity (FMA-UE)
Time frame: baseline; 3weeks (end of treatment); 7weeks (follow-up)
Comprehensive clinical measurement tool of upper limb functions after stroke. Range score form 0 to 66 points, a higher score represents an improvement.
6 secondary outcomes
Change in the Box and Block Test
Time frame: baseline; 3weeks (end of treatment); 7weeks (follow-up)
Change in the Modified Ashworth Scale
Time frame: baseline; 3weeks (end of treatment); 7weeks (follow-up)
Change in the functional movements of upper limb
Time frame: baseline; 3weeks (end of treatment); 7weeks (follow-up)
Change in the cortical excitability
Time frame: baseline; 3weeks (end of treatment); 7weeks (follow-up)
Change in the cortical oscillations
Time frame: baseline; 3weeks (end of treatment); 7weeks (follow-up)
Change in the cortical connectivity
Time frame: baseline; 3weeks (end of treatment); 7weeks (follow-up)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2025.
- Results publication: PubMed 27679565Hatem SM, Saussez G, Della Faille M, Prist V, Zhang X, Dispa D, Bleyenheuft Y. Rehabilitation of Motor Function after Stroke: A Multiple Systematic Review Focused on Techniques to Stimulate Upper Extremity Recovery. Front Hum Neurosci. 2016 Sep 13;10:442. doi: 10.3389/fnhum.2016.00442. eCollection 2016.
- Results publication: PubMed 28642168Mohan H, de Haan R, Mansvelder HD, de Kock CPJ. The posterior parietal cortex as integrative hub for whisker sensorimotor information. Neuroscience. 2018 Jan 1;368:240-245. doi: 10.1016/j.neuroscience.2017.06.020. Epub 2017 Jun 19.
- Results publication: PubMed 27145936Winstein CJ, Stein J, Arena R, Bates B, Cherney LR, Cramer SC, Deruyter F, Eng JJ, Fisher B, Harvey RL, Lang CE, MacKay-Lyons M, Ottenbacher KJ, Pugh S, Reeves MJ, Richards LG, Stiers W, Zorowitz RD; American Heart Association Stroke Council, Council on Cardiovascular and Stroke Nursing, Council on Clinical Cardiology, and Council on Quality of Care and Outcomes Research. Guidelines for Adult Stroke Rehabilitation and Recovery: A Guideline for Healthcare Professionals From the American Heart Association/American Stroke Association. Stroke. 2016 Jun;47(6):e98-e169. doi: 10.1161/STR.0000000000000098. Epub 2016 May 4.
- Results publication: PubMed 18524898Koch G, Fernandez Del Olmo M, Cheeran B, Schippling S, Caltagirone C, Driver J, Rothwell JC. Functional interplay between posterior parietal and ipsilateral motor cortex revealed by twin-coil transcranial magnetic stimulation during reach planning toward contralateral space. J Neurosci. 2008 Jun 4;28(23):5944-53. doi: 10.1523/JNEUROSCI.0957-08.2008.
- Results publicationReti IM. Brain Stimulation: Methodologies and Interventions. John Wiley & Sons. 2015
- Results publication: PubMed 23966698Veniero D, Ponzo V, Koch G. Paired associative stimulation enforces the communication between interconnected areas. J Neurosci. 2013 Aug 21;33(34):13773-83. doi: 10.1523/JNEUROSCI.1777-13.2013.
- Results publication: PubMed 23968834Chao CC, Karabanov AN, Paine R, Carolina de Campos A, Kukke SN, Wu T, Wang H, Hallett M. Induction of motor associative plasticity in the posterior parietal cortex-primary motor network. Cereb Cortex. 2015 Feb;25(2):365-73. doi: 10.1093/cercor/bht230. Epub 2013 Aug 22.
- Results publication: PubMed 17876068Kwakkel G, Kollen BJ, Krebs HI. Effects of robot-assisted therapy on upper limb recovery after stroke: a systematic review. Neurorehabil Neural Repair. 2008 Mar-Apr;22(2):111-21. doi: 10.1177/1545968307305457. Epub 2007 Sep 17.
- Results publication: PubMed 30677307Morone G, Spitoni GF, De Bartolo D, Ghanbari Ghooshchy S, Di Iulio F, Paolucci S, Zoccolotti P, Iosa M. Rehabilitative devices for a top-down approach. Expert Rev Med Devices. 2019 Mar;16(3):187-195. doi: 10.1080/17434440.2019.1574567. Epub 2019 Feb 6.
- Results publication: PubMed 30476999Koch G, Bonni S, Casula EP, Iosa M, Paolucci S, Pellicciari MC, Cinnera AM, Ponzo V, Maiella M, Picazio S, Sallustio F, Caltagirone C. Effect of Cerebellar Stimulation on Gait and Balance Recovery in Patients With Hemiparetic Stroke: A Randomized Clinical Trial. JAMA Neurol. 2019 Feb 1;76(2):170-178. doi: 10.1001/jamaneurol.2018.3639.
- Results publication: PubMed 31023258Chen YJ, Huang YZ, Chen CY, Chen CL, Chen HC, Wu CY, Lin KC, Chang TL. Intermittent theta burst stimulation enhances upper limb motor function in patients with chronic stroke: a pilot randomized controlled trial. BMC Neurol. 2019 Apr 25;19(1):69. doi: 10.1186/s12883-019-1302-x.
- Results publication: PubMed 30202655Palermo E, Hayes DR, Russo EF, Calabro RS, Pacilli A, Filoni S. Translational effects of robot-mediated therapy in subacute stroke patients: an experimental evaluation of upper limb motor recovery. PeerJ. 2018 Sep 4;6:e5544. doi: 10.7717/peerj.5544. eCollection 2018.
- 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.
Giacomo Koch, prof. principal investigator
IRCCS Santa Lucia Foundation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cortico-cortical stimulation plus robot-assisted therapy in people with Stroke and Stroke, Ischemic, run by I.R.C.C.S. Fondazione Santa Lucia 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 3 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 20 Feb 2025. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Giacomo Koch, prof. (+390651501181, g.koch@hsantalucia.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the Fugl-Meyer Assessment Scale for Upper Extremity (FMA-UE) (time frame: baseline; 3weeks (end of treatment); 7weeks (follow-up)). 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 NCT05478434, which also lists 13 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 20 Feb 2025.