Clinical Study for Upper Limb Motor Restoration in Chronic Stroke Patients Using Personalized Neuro-technologies

NCT04448483 | Completed DMC

• 1 other identifier: AVANCER
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke, Cerebral

Outcome Measures

Primary Outcomes (6)

• Change in functional improvement of upper limbs along training sessions

  Measurement of improvement before and after training of upper limb, using Fugl-Meyer (FMA) scale (0-66). FMA is a stroke specific index to estimate motor function. Measurements are performed every second training session and at the evaluation visit.

  10 months average

• Change in speed and coordination of the affected side

  Measurement of speed and coordination of the affected side are performed using FMA modified score, max 54. Measurements are performed every second training session.

  10 months average

• Change in sensorimotor status in the two upper limbs

  Measurement of sensorimotor status in the two upper limbs, using Fugl-Meyer (FMA) scale (0-66). Measurements are performed at the evaluation visit.

  10 months average

• Action Reach Arm Test (ARAT)

  Upper limb functions changes measured by the ARAT test (ARAT scale: 0-57) in the two upper limbs. Measurements are performed at the evaluation visit.

  10 months average

• Fatigue Visual Analog Scale (VAS)

  Measurement of fatigue is made with the Visual Analog Scale (VAS; 0-100). Measurements are performed every second training session.

  10 months average

• Rivermead Assessment of Somatosensory Performance (RASP)

  Somatosensory function are measured with RASP (RASP; 0-210) in the two upper limbs. Measurements are performed at the evaluation visit.

  10 months average

Secondary Outcomes (1)

• Brain stimulation effectiveness in BCI-aided motor therapy

  10 months average

Study Arms (2)

Group A

EXPERIMENTAL

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.

Device: Paretic upper limb functional electric stimulation through RehaStim; Device: Non-invasive transcranial current stimulation through DC-Stimulator

Group B

EXPERIMENTAL

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.

Device: Paretic upper limb functional electric stimulation through RehaStim; Device: Non-invasive transcranial current stimulation through DC-Stimulator

Interventions

Paretic upper limb functional electric stimulation through RehaStim DEVICE

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.

Group A; Group B

Non-invasive transcranial current stimulation through DC-Stimulator DEVICE

Non-invasive brain stimulation in the form of transcranial direct current stimulation will be provided in addition to the previous intervention.

Group A; Group B

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Wyss Center for Bio and Neuroengineering: lead
• Ecole Polytechnique Fédérale de Lausanne: collaborator

Study Sites (1)

Clinique Romande de Readaptation (CRR)

Sion, Switzerland

Location

Related Publications (2)

• 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.

  PMID: 37437575 DERIVED

• 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.

  PMID: 35873764 DERIVED

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

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

Study Officials

• Friedhelm Hummel, MD

  Ecole Politechnique Federale de Lausanne

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 15, 2020
• First Posted: June 26, 2020
• Study Start: October 6, 2020
• Primary Completion: November 17, 2023
• Study Completion: November 17, 2023
• Last Updated: December 5, 2023

Record last verified: 2023-12

Locations

CH (1)