Clinical trial NCT04448483: Clinical Study for Upper Limb Motor Restoration in Chronic Stroke Patients Using Personalized Neuro-technologies
Official title: Accident Vasculaire cérébral et Apport Des Neurotechnologies individualisées Chez la Personne Avec Une hémiparésie Chronique : Une Etude Clinique Prospective Visant à Restaurer la mobilité du Membre supérieur
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke, Cerebral
Lead sponsor: Wyss Center for Bio and Neuroengineering
Sponsor class: OTHER
Collaborators: name: Ecole Polytechnique Fédérale de Lausanne
First posted: 2020-06-26
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: This study aims to evaluate safety, tolerability and efficacy of a new treatment for upper limb motor rehabilitation after severe stroke using non-invasive neurotechnologies. The investigational system is used alone or coupled with brain stimulation provided by transcranic direct current stimulation.

Detailed description: This study aims at providing two interventions:

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.

Eligibility criteria: Inclusion Criteria:

* Chronic cerebral stroke patients (at least 6 months after the event).
* 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:

* Patient with an active implantable device or wearing an active device.
* 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.

Primary outcomes:
measure: Change in functional improvement of upper limbs along training sessions
timeFrame: 10 months average
measure: Change in speed and coordination of the affected side
timeFrame: 10 months average
measure: Change in sensorimotor status in the two upper limbs
timeFrame: 10 months average
measure: Action Reach Arm Test (ARAT)
timeFrame: 10 months average
measure: Fatigue Visual Analog Scale (VAS)
timeFrame: 10 months average
measure: Rivermead Assessment of Somatosensory Performance (RASP)
timeFrame: 10 months average
Secondary outcomes:
measure: Brain stimulation effectiveness in BCI-aided motor therapy
timeFrame: 10 months average
Other outcomes:
Locations:
city: Sion
country: Switzerland
facility: Clinique Romande de Readaptation (CRR)
Study officials:
affiliation: Ecole Politechnique Federale de Lausanne
name: Friedhelm Hummel, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.