Combining brain stimulation and robot therapy for upper limb recovery after stroke
Cortico-cortical Stimulation and Robot-assisted Therapy a New Approach of Upper Limb Functional Recovery After Stroke
NA · I.R.C.C.S. Fondazione Santa Lucia · NCT05478434
This study is testing if combining brain stimulation with robot therapy can help stroke survivors recover better use of their arms.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 32 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | I.R.C.C.S. Fondazione Santa Lucia (other) |
| Locations | 1 site (Rome) |
| Trial ID | NCT05478434 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of paired associative stimulation targeting the posterior-parietal cortex and primary motor cortex, combined with robot-assisted therapy, on upper limb recovery in stroke survivors. The approach aims to enhance motor and sensory integration, potentially improving the quality of life for individuals with upper limb impairments. Participants will receive either the active treatment or a sham stimulation alongside robot-assisted training, which is designed to promote neural plasticity and motor relearning. The study focuses on individuals who have experienced their first chronic ischemic stroke and have significant upper limb impairment.
Who should consider this trial
Good fit: Ideal candidates are individuals who have experienced their first chronic ischemic stroke with moderate to severe upper limb impairment.
Not a fit: Patients with a history of seizures, severe general impairment, or cognitive issues may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve upper limb function and quality of life for stroke survivors.
How similar studies have performed: Other studies have shown promise in using similar approaches of brain stimulation and robotic therapy for rehabilitation, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. first ever chronic ischemic stroke; 2. hemiparesis due to left or right subcortical or cortical lesion in the territory of the middle cerebral artery; 3. severe or moderate residual upper limb impairment (FMA \< 52 in the motor domain A/D) Exclusion Criteria: 1. history of seizures; 2. severe general impairment or concomitant diseases; 3. treatment with benzodiazepines, baclofen, and antidepressants; 4. Intracranial metal implants; 5. cardiac pacemaker; 6. pregnancy status; 7. orthopedic contraindications for upper limb; 8. upper limb pain; 9. cognitive impairment (MMSE \< 23); 10. presence of unilateral spatial neglect
Where this trial is running
Rome
- Santa Lucia Foundation — Rome, Italy (RECRUITING)
Study contacts
- Principal investigator: Giacomo Koch, prof. — IRCCS Santa Lucia Foundation
- Study coordinator: Giacomo Koch, prof.
- Email: g.koch@hsantalucia.it
- Phone: +390651501181
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Stroke, Stroke, Ischemic, Transcranial Magnetic Stimulation, Robot-assisted Therapy