Cortico-cortical Stimulation and Robot-assisted Therapy for Upper Limb Recovery After Stroke (CCS&RAT)

NCT05478434 | Recruiting

• 1 other identifier: PROG.910
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Stroke; Stroke, Ischemic

Keywords

Stroke; Transcranial Magnetic Stimulation; Robot-assisted Therapy

Outcome Measures

Primary Outcomes (1)

• 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.

  baseline; 3weeks (end of treatment); 7weeks (follow-up)

Secondary Outcomes (6)

• Change in the Box and Block Test

  baseline; 3weeks (end of treatment); 7weeks (follow-up)

• Change in the Modified Ashworth Scale

  baseline; 3weeks (end of treatment); 7weeks (follow-up)

• Change in the functional movements of upper limb

  baseline; 3weeks (end of treatment); 7weeks (follow-up)

• Change in the cortical excitability

  baseline; 3weeks (end of treatment); 7weeks (follow-up)

• Change in the cortical oscillations

  baseline; 3weeks (end of treatment); 7weeks (follow-up)

Study Arms (2)

Robot and stimulation PPC-M1

EXPERIMENTAL

Combined paired pulse stimulation (PAS) with robot-assisted therapy

Device: Cortico-cortical stimulation plus robot-assisted therapy

Robot and sham stimulation PPC-M1

SHAM COMPARATOR

Combined sham PAS with robot-assisted therapy

Device: Sham cortico-cortical stimulation plus robot-assisted therapy

Interventions

Cortico-cortical stimulation plus robot-assisted therapy DEVICE

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.

Robot and stimulation PPC-M1

Sham cortico-cortical stimulation plus robot-assisted therapy DEVICE

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.

Robot and sham stimulation PPC-M1

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• history of seizures;
• severe general impairment or concomitant diseases;
• treatment with benzodiazepines, baclofen, and antidepressants;
• Intracranial metal implants;
• cardiac pacemaker;
• pregnancy status;
• orthopedic contraindications for upper limb;
• upper limb pain;
• cognitive impairment (MMSE \< 23);
• presence of unilateral spatial neglect

Sponsors & Collaborators

• I.R.C.C.S. Fondazione Santa Lucia: lead
• Università degli studi di Roma Foro Italico: collaborator

Study Sites (1)

Santa Lucia Foundation

Rome, 00179, Italy

RECRUITING

Related Publications (13)

• 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.

  PMID: 27679565 RESULT

• Mohan 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.

  PMID: 28642168 RESULT

• Winstein 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.

  PMID: 27145936 RESULT

• Koch 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.

  PMID: 18524898 RESULT

• Reti IM. Brain Stimulation: Methodologies and Interventions. John Wiley & Sons. 2015

  RESULT

• 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.

  PMID: 23966698 RESULT

• Chao 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.

  PMID: 23968834 RESULT

• Kwakkel 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.

  PMID: 17876068 RESULT

• Morone 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.

  PMID: 30677307 RESULT

• Koch 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.

  PMID: 30476999 RESULT

• Chen 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.

  PMID: 31023258 RESULT

• Palermo 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.

  PMID: 30202655 RESULT

• Cinnera 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.

  PMID: 38129910 DERIVED

MeSH Terms

Conditions

Stroke; Ischemic Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Giacomo Koch, prof.

  IRCCS Santa Lucia Foundation

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Giacomo Koch, prof.

CONTACT

+390651501181; g.koch@hsantalucia.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: The recruiters, outcomes assessors, physical therapists, participants and their caregivers will be blinded with respect to participants' allocation for the entire period of the study.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomised Clinical trial

Study Record Dates

• First Submitted: July 6, 2022
• First Posted: July 28, 2022
• Study Start: August 21, 2022
• Primary Completion: August 1, 2025
• Study Completion: October 1, 2025
• Last Updated: February 20, 2025

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)