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

December 4, 2023 updated by: Wyss Center for Bio and Neuroengineering

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
20

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Switzerland
      • Sion, Switzerland
        • Clinique Romande de Readaptation (CRR)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 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.
Device: 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.

Device: 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.
Experimental: 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.
Device: 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.

Device: 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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in functional improvement of upper limbs along training sessions
Time Frame: 10 months average

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
Time Frame: 10 months average

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
Time Frame: 10 months average

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)
Time Frame: 10 months average

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)
Time Frame: 10 months average
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)
Time Frame: 10 months average

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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Brain stimulation effectiveness in BCI-aided motor therapy
Time Frame: 10 months average

The measurement of the effectiveness of brain stimulation is measured by FMA scores of all patients at initial, inter-intervention and final evaluation. This measurement is made between the end and the beginning of each intervention for each patient.

Comparison is made by using one-way ANOVA if data normally distributed, or Kruskal Wallis test if otherwise. Secondary analysis measures are calculated for each patient once they complete the study. It will consist in the evaluation of effectiveness of BCI-aided motor therapy without and with brain stimulation. Group comparison is done with inferential statistics for full and partial populations. Similar comparisons and judgement criteria are applied for clinical scales and questionnaires.
10 months average

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Wyss Center for Bio and Neuroengineering

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Ecole Polytechnique Fédérale de Lausanne

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Friedhelm Hummel, MD, Ecole Politechnique Federale de Lausanne

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 6, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 17, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 17, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 15, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 23, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 26, 2020

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 5, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 4, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • AVANCER

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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