Clinical Study for Upper Limb Motor Restoration in Chronic Stroke Patients Using Personalized Neuro-technologies
NCT ID: NCT04448483
Last Updated: 2023-12-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
20 participants
INTERVENTIONAL
2020-10-06
2023-11-17
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
In the first intervention, a brain computer interface able to non-invasively detect motor intention from the non-invasive measure of brain activity by using electroencephalography (BrainVision, V-amp) activates a robotic glove (Gloreha Sinfonia, Idrogenet Srl) that will assist-as-needed hand movements and paretic upper limb functional electric stimulation (RehaStim, Hasomed). The latter will activate upper limb muscles to perform motor rehabilitation exercises for the upper limb. The motor rehabilitation exercises include upper limb and hand mobilization and functional tasks, such as hand open/closing, wrist flexion/extension, and reach and grasp a cup, keep and release.
In the second intervention, non-invasive brain stimulation (DC-Stimulator, NeuroConn) in the form of transcranial direct current stimulation will be provided in addition to the previous intervention.
Each participant will perform a minimum of 11 rehabilitative sessions for the first intervention and a minimum of 11 rehabilitative sessions for the second intervention, for a total minimum of 22 rehabilitative sessions. If the participant recovers with the intervention, the relative rehabilitative session continues to be proposed until patients will reaches a "plateau". The intervention will switch from 1 to 2 if the participant does not improve anymore with the 1st intervention. If the patient does not improve anymore with the 2nd intervention the interventional part of the trial will be finished. The intervention(s) will terminate also if the participant continues to progress after 6 months of inclusion. As the study is especially designed for personalization of intervention for every patient, it is not possible to determine a priori the number of sessions for each participant, because they depend on the response of each participant to the intervention. The duration of each rehabilitative visit is about two and half hours.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
BASIC_SCIENCE
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Group A
Patients belonging to group A will start intervention I, immediately after baseline. We will recruit about 25 for group A (randomization will take into account the two to one study design) in order to have about 20 patients in Group A that will complete the study.
Paretic upper limb functional electric stimulation through RehaStim
The stimulation will activate upper limb muscles to perform motor rehabilitation exercises for the upper limb with the help of the Gloreha Sinfonia robotic glove that will assist-as-needed hands movements. Motor intention will be detected by a BCI (Brain Computer Interface) from the non-invasive measure of brain activity by using electroencephalography.
The motor rehabilitation exercises include upper limb and hand mobilization and functional tasks, such as hand open/closing, wrist flexion/extension, and reach and grasp a cup, keep and release.
Non-invasive transcranial current stimulation through DC-Stimulator
Non-invasive brain stimulation in the form of transcranial direct current stimulation will be provided in addition to the previous intervention.
Group B
Patients belonging to group B will follow an observation period (max. 3 months) before starting intervention I. We will recruit about 15 patients for group B (randomization will take into account the two to one study design) in order to have about 10 patients in Group B that will complete the study.
Paretic upper limb functional electric stimulation through RehaStim
The stimulation will activate upper limb muscles to perform motor rehabilitation exercises for the upper limb with the help of the Gloreha Sinfonia robotic glove that will assist-as-needed hands movements. Motor intention will be detected by a BCI (Brain Computer Interface) from the non-invasive measure of brain activity by using electroencephalography.
The motor rehabilitation exercises include upper limb and hand mobilization and functional tasks, such as hand open/closing, wrist flexion/extension, and reach and grasp a cup, keep and release.
Non-invasive transcranial current stimulation through DC-Stimulator
Non-invasive brain stimulation in the form of transcranial direct current stimulation will be provided in addition to the previous intervention.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Paretic upper limb functional electric stimulation through RehaStim
The stimulation will activate upper limb muscles to perform motor rehabilitation exercises for the upper limb with the help of the Gloreha Sinfonia robotic glove that will assist-as-needed hands movements. Motor intention will be detected by a BCI (Brain Computer Interface) from the non-invasive measure of brain activity by using electroencephalography.
The motor rehabilitation exercises include upper limb and hand mobilization and functional tasks, such as hand open/closing, wrist flexion/extension, and reach and grasp a cup, keep and release.
Non-invasive transcranial current stimulation through DC-Stimulator
Non-invasive brain stimulation in the form of transcranial direct current stimulation will be provided in addition to the previous intervention.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* First ever clinical manifest stroke.
* No or minimal residual voluntary finger extension.
* Upper limb FM score \< 20.
* Age \> 18 years.
* Right or left severe hemiparesis.
* Ischemic or hemorrhagic stroke with intact hand knob area.
Exclusion Criteria
* Occurrence of new clinically manifest stroke.
* Cerebellar stroke.
* Drug or alcohol dependency.
* Pregnancy.
* Refusal to perform any proposed pregnancy test for women in childbearing age (18 to menopausal age).
* Psychotic symptoms and significant psychopharmacologic treatments with neuroleptics and/or Lithium and antiepileptics
* Use of medication that significantly interacts with non-invasive brain stimulation being benzodiazepines, tricyclic antidepressant and antipsychotics.
* Severe spasticity that prevent the patient to use the robotic orthosis (indicative Modified Ashworth Scale \> 3).
* Severe cognitive problems and severe neglect.
* Physical features impeding the recording of brain signals or the muscular signals stimulation (voluminous hair and large amount of subcutaneous fat in the arms).
* Severe heart disease.
* Allergy to latex and dermatitis.
* Epileptic seizures or using medications that reduce the threshold for epileptic seizures.
* Travel distance to the study site more than 70 Km.
* Involvement in other clinical treatment trials related to stroke.
* Participant does not want to be informed about the potential fortuitous discoveries that may contribute to the prevention, diagnosis and treatment of existing or probable diseases in the future.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Ecole Polytechnique Fédérale de Lausanne
OTHER
Wyss Center for Bio and Neuroengineering
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Friedhelm Hummel, MD
Role: PRINCIPAL_INVESTIGATOR
Ecole Politechnique Federale de Lausanne
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Clinique Romande de Readaptation (CRR)
Sion, , Switzerland
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Bigoni C, Beanato E, Harquel S, Herve J, Oflar M, Crema A, Espinosa A, Evangelista GG, Koch P, Bonvin C, Turlan JL, Guggisberg A, Morishita T, Wessel MJ, Zandvliet SB, Hummel FC. Novel personalized treatment strategy for patients with chronic stroke with severe upper-extremity impairment: The first patient of the AVANCER trial. Med. 2023 Sep 8;4(9):591-599.e3. doi: 10.1016/j.medj.2023.06.006. Epub 2023 Jul 11.
Bigoni C, Zandvliet SB, Beanato E, Crema A, Coscia M, Espinosa A, Henneken T, Herve J, Oflar M, Evangelista GG, Morishita T, Wessel MJ, Bonvin C, Turlan JL, Birbaumer N, Hummel FC. A Novel Patient-Tailored, Cumulative Neurotechnology-Based Therapy for Upper-Limb Rehabilitation in Severely Impaired Chronic Stroke Patients: The AVANCER Study Protocol. Front Neurol. 2022 Jul 7;13:919511. doi: 10.3389/fneur.2022.919511. eCollection 2022.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
AVANCER
Identifier Type: -
Identifier Source: org_study_id