Stroke, CerebralAVANCERNCT04448483
Clinical Study for Upper Limb Motor Restoration in Chronic Stroke Patients Using Personalized Neuro-technologies
A study testing Paretic upper limb functional electric stimulation through RehaStim and Non-invasive transcranial current stimulation through DC-Stimulator in people with Stroke, Cerebral, run by Wyss Center for Bio and Neuroengineering at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Cerebral
- What is being tested?
- Paretic upper limb functional electric stimulation through RehaStim and Non-invasive transcranial current stimulation through DC-Stimulator
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSwitzerland
- Study dates
- 6 Oct 2020to 17 Nov 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Stroke, Cerebral
- Being tested
- Paretic upper limb functional electric stimulation through RehaStim, Non-invasive transcranial current stimulation through DC-Stimulator
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Paretic upper limb functional electric stimulation through RehaStimDevice
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-StimulatorDevice
Non-invasive brain stimulation in the form of transcranial direct current stimulation will be provided in addition to the previous intervention.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Paretic upper limb functional electric stimulation through RehaStim; Device: Non-invasive transcranial current stimulation through DC-Stimulator |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 10 months average
Secondary outcomes (1)
Brain stimulation effectiveness in BCI-aided motor therapy
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.
Measured: 10 months average
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2020
- Study start6 Oct 2020
- Primary completion17 Nov 2023
- Study completion17 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Stroke, CerebralStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wyss Center for Bio and Neuroengineering
- Sponsor type
- University, hospital or other
- Collaborators
- Ecole Polytechnique Fédérale de Lausanne
- Responsible party
- Sponsor
- Investigators
- Friedhelm Hummel, MD, Principal investigator, Ecole Politechnique Federale de Lausanne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04448483
- Sponsor's protocol ID
- AVANCER
- Acronym
- AVANCER
- Status last verified
- Dec 2023
- First submitted
- 15 Jun 2020
- Last updated
- 5 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 37437575Bigoni 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.
PubMed 35873764
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04448483
- Acronym / sponsor ID
- AVANCER / AVANCER
- Conditions
- Stroke, Cerebral
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Wyss Center for Bio and NeuroengineeringUniversity, hospital or other
- Collaborators
- Ecole Polytechnique Fédérale de Lausanne
- Study start
- 6 Oct 2020 (actual)
- Primary completion
- 17 Nov 2023 (actual)
- Study completion
- 17 Nov 2023 (actual)
- First posted
- 26 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Device: Paretic upper limb functional electric stimulation through RehaStim, Device: Non-invasive transcranial current stimulation through DC-StimulatorPatients 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. |
| Group B | Experimental | Device: Paretic upper limb functional electric stimulation through RehaStim, Device: Non-invasive transcranial current stimulation through DC-StimulatorPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (17 listed)
- Patient with an active implantable device or wearing an active device.
- Occurrence of new clinically manifest stroke.
- Cerebellar stroke.
- Drug or alcohol dependency.
- Pregnancy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Paretic upper limb functional electric stimulation through RehaStimThe 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 | Group A, Group B |
| Non-invasive transcranial current stimulation through DC-StimulatorNon-invasive brain stimulation in the form of transcranial direct current stimulation will be provided in addition to the previous intervention. | Device | Group A, Group B |
Primary outcome
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.
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.
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.
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.
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.
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.
1 secondary outcome
Brain stimulation effectiveness in BCI-aided motor therapy
Time frame: 10 months average
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2023.
- Derived from this study: PubMed 37437575Bigoni 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.
- Derived from this study: PubMed 35873764Bigoni 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Friedhelm Hummel, MD principal investigator
Ecole Politechnique Federale de Lausanne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Paretic upper limb functional electric stimulation through RehaStim and Non-invasive transcranial current stimulation through DC-Stimulator in people with Stroke, Cerebral, run by Wyss Center for Bio and Neuroengineering at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in functional improvement of upper limbs along training sessions (time frame: 10 months average). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04448483, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2023.