First Ever Clinical StrokeRECOMBINENCT01644929
Rehabilitation Combined With Bihemispherictranscranial Direct Current Stimulation in Subacute Ischemic Stroke
A study testing transcranial direct current stimulation (tDCS) in people with First Ever Clinical Stroke and Ischemic Stroke, run by Dr. med. Carlo Cereda at 3 sites in Switzerland.
Trial summary
Rehabilitation after stroke improves motor functions by promoting plastic changes however, after completing standard rehabilitation, 50-60% of patients still exhibit some degree of motor impairment and require at least partial assistance in activities of day living. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- First Ever Clinical Stroke, Ischemic Stroke, Subacute Phase
- What is being tested?
- transcranial direct current stimulation (tDCS)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 3 sitesSwitzerland
- Study dates
- Mar 2013to Feb 2018
- 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
- Ischemic lesions in the territory of middle cerebral artery subcortical or subcortical/cortical confirmed neuroimaging
- Inclusion must be in the sub-acute phase defined as within 2-4 weeks after stroke
- Persistent hemiparesis, indicated by a score of 1-3 on the motor arm item of the NIH Stroke Scale (NIHSS) (Brott et al. 1989) but wrist and finger movement is not required
- No UE injury or conditions that limited use prior to the stroke.
- The patient is >18 years old.
- The patient has subscribed the informed consent
Who cannot join
- History of epilepsy, brain tumor, major head trauma, learning disorder, severe cognitive impairment, drug or alcohol abuse, major psychiatric illness
- Use of medications that may lower seizure threshold (e.g., metronidazole, fluoroquinolones)
- Severe pain in the affected upper limb (>=8 on the shoulder item of the "joint pain during passive motion" of the Fugl-Meyer Assessment Upper Extremity)
- Further stroke or other significant medical complication during the study
- Evidence of severe leucoencephalopathy (grade IV according to the Fazeka's scale)
- Important aphasia that would impair the understanding and performance of the assessment scales
Trial locations and contacts
3 sites in 1 country.
Switzerland3 sites, 1 recruiting
- Withdrawn
Universitätsspital Bern, Inselspital, Neuropsychologische Rehabilitation
Bern, 3010
- Recruiting
Clinica Hildebrand, Centro di riabilitazione Brissago
Brissago, 6614
Paolo Rossi, MD, +41 91 786 86 86, p.rossi@clinica-hildebrand.ch
Paolo Rossi, MD
- Terminated
HELIOS Klinik Zihlschlacht AG, Neurologisches Rehabilitationszentrum
Zihlschlacht, 8588
About this study
Official title: Rehabilitation Combined With Bihemispherictranscranial Direct Current Stimulation in Subacute Ischemic Stroke to Increase Upper Limb Motor Recovery, a Randomised, Controlled, Double-blind Study
Rehabilitation after stroke improves motor functions by promoting plastic changes however, after completing standard rehabilitation, 50-60% of patients still exhibit some degree of motor impairment and require at least partial assistance in activities of day living. Therefore, the exploration of other approaches to promote recovery is compulsory. Non invasive brain stimulation and motor rehabilitation are thought to share similar mechanisms in inducing neuroplastic changes in the human cortex and an emerging field of research is focusing on the possibility of coupling both therapies in order to achieve an additive effect and improve outcome.
We hypothesize that coupling bihemispheric transcranial direct current stimulation (tDCS) with simultaneous physical/occupational therapy in the subacute phase of ischemic stroke patients may improve upper limb motor recovery in humans.
This is a randomized, controlled, double blind, cross-over, multicentre, clinical trial. Thirty-six ischemic stroke patients in the subacute phase will be recruited in three centers of neurorehabilitation in Switzerland. After stratification based on the Fugl-Meyer Assessment Upper Extremity according to the severity of the deficit, the patient will be randomized to receive besides standardized physical/occupational treatment according to the Impairment-Oriented Training, tDCS of themotor cortex (1.5 mA, 30 minutes) (group 1: 12 patients) or sham stimulation (without current) (group 2: 12 patients). After three weeks of treatment group 1 and 2 will cross-over and will be treated for other three weeks. Group 3 (12 patients) will receive routine physical/occupational treatment and sham tDCS for six weeks. Assessment will be performed before starting tDCS, at week 3, 6 and at 6 months. Outcome measures are the Fugl-Meyer Assessment Upper Extremity, the extended Barthel Index, the Ashworth scale, the Test of Upper Limb Apraxia (only baseline, week 6, month6), the grip strength evaluated by the Jamar Hydraulic Hand dynamometer. At baseline at week 6 and at month 6 depression will be assessed by the Hamilton depression Rating Scale.
- Conditions
- First Ever Clinical Stroke, Ischemic Stroke, Subacute Phase, Persistent Hemiparesis of Upper Extremity
- Being tested
- transcranial direct current stimulation (tDCS), Sham stimulation, then tDCS, Sham stimulation
- Keywords
- hemiparesis, bihemispheric transcranial direct current stimulation, ischemic stroke, subacute, rehabilitation, physiotherapy, ergotherapy
- Medical subject headings
- Ischemic Stroke, Paresis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transcranial direct current stimulation (tDCS)Procedure or surgery
Anodal tDCS of the ipsilesional motor cortex and cathodal tDCS of contralesional motor cortex (1.5 mA, 30 minutes) for 15 days during three weeks, then sham stimulation for 30 seconds on 15 days during 3 weeks
Sham stimulation, then tDCSProcedure or surgery
Sham stimulation for 30 seconds on 15 days during 3 weeks, then anodal tDCS of the ipsilesional motor cortex and cathodal tDCS of contralesional motor cortex (1.5 mA, 30 minutes) for 15 days during three weeks
Sham stimulationProcedure or surgery
Sham stimulation for 30 seconds on 15 days during 6 weeks
| Study group | Role | What they receive |
|---|---|---|
| 1 tDCS-Sham | Experimental | tDC stimulation for 3 weeks, then cross-over to sham stimulation Receives: Procedure: transcranial direct current stimulation (tDCS) |
| 2 Sham-tDCS | Experimental | Sham stimulation for 3 weeks, then cross over to tDCS stimulation Receives: Procedure: Sham stimulation, then tDCS |
| 3 Sham-Sham | Sham comparator | Treatment for 6 weeks daily with sham stimulation Receives: Procedure: Sham stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fugl-Meyer Assessment Upper Extremity
Investigator administered questionnaire
Measured: 6 weeks
Secondary outcomes (15)
Fugl-Meyer Assessment Upper Extremity
Investigator administered questionnaire
Measured: 3 weeks
Fugl-Meyer Assessment Upper Extremity
Investigator administered questionnaire
Measured: 6 months
Barthel Index
Investigator administered questionnaire
Measured: 3 weeks
Barthel Index
Investigator administered questionnaire
Measured: 6 weeks
Barthel Index
Investigator administered questionnaire
Measured: 6 months
Ashworth scale
Investigator administered questionnaire
Measured: 3 weeks
Ashworth scale
Investigator administered questionnaire
Measured: 6 weeks
Ashworth scale
Investigator administered questionnaire
Measured: 6 months
Test of Upper Limb Apraxia (TULIA)
investigator administered questionnaire
Measured: 6 weeks
Test of Upper Limb Apraxia (TULIA)
investigator administered questionnaire
Measured: 6 months
Grip strength
Jamar Hydraulic Hand dynamometer
Measured: 3 weeks
Grip strength
Jamar Hydraulic Hand dynamometer
Measured: 6 weeks
Grip strength
Jamar Hydraulic Hand dynamometer
Measured: 6 months
Hamilton depression Rating scale
Patient administered questionnaire
Measured: 6 weeks
Hamilton depression Rating scale
Patient administered questionnaire
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2012 (estimated)
- Study startMar 2013
- Primary completionFeb 2018 (estimated)
- Study completionFeb 2018 (estimated)
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 First Ever Clinical StrokeStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dr. med. Carlo Cereda
- Sponsor type
- Other government
- Collaborators
- Insel Gruppe AG, University Hospital Bern, Clinica Hildebrand Brissago, Advisory Board Research Ente Ospedaliero Cantonale
- Responsible party
- Sponsor-investigator, Dr. med. Carlo Cereda, Ospedale Civico, Lugano
- Investigators
- Carlo Cereda, MD, Principal investigator, Ospedale Regionale di Lugano - Civico
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01644929
- Sponsor's protocol ID
- EOC.NSI.11.02
- Acronym
- RECOMBINE
- Status last verified
- Sep 2017
- First submitted
- 17 Jul 2012
- Last updated
- 19 Sep 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Lindenberg R, Renga V, Zhu LL, Nair D, Schlaug G. Bihemispheric brain stimulation facilitates motor recovery in chronic stroke patients. Neurology. 2010 Dec 14;75(24):2176-84. doi: 10.1212/WNL.0b013e318202013a. Epub 2010 Nov 10.
PubMed 21068427Elsner B, Kugler J, Pohl M, Mehrholz J. Transcranial direct current stimulation (tDCS) for improving activities of daily living, and physical and cognitive functioning, in people after stroke. Cochrane Database Syst Rev. 2020 Nov 11;11(11):CD009645. doi: 10.1002/14651858.CD009645.pub4.
PubMed 33175411
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rehabilitation Combined With Bihemispherictranscranial Direct Current Stimulation in Subacute Ischemic Stroke to Increase Upper Limb Motor Recovery, a Randomised, Controlled, Double-blind Study
- ClinicalTrials.gov ID
- NCT01644929
- Acronym / sponsor ID
- RECOMBINE / EOC.NSI.11.02
- Conditions
- First Ever Clinical Stroke, Ischemic Stroke, Subacute Phase, Persistent Hemiparesis of Upper Extremity
- Keywords
- hemiparesis, bihemispheric transcranial direct current stimulation, ischemic stroke, subacute, rehabilitation, physiotherapy, ergotherapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Dr. med. Carlo CeredaOther government
- Collaborators
- Insel Gruppe AG, University Hospital Bern, Clinica Hildebrand Brissago, Advisory Board Research Ente Ospedaliero Cantonale
- Study start
- Mar 2013
- Primary completion
- Feb 2018 (estimated)
- Study completion
- Feb 2018 (estimated)
- First posted
- 19 Jul 2012 (estimated)
- 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.
Rehabilitation after stroke improves motor functions by promoting plastic changes however, after completing standard rehabilitation, 50-60% of patients still exhibit some degree of motor impairment and require at least partial assistance in activities of day living. Therefore, the exploration of other approaches to promote recovery is compulsory. Non invasive brain stimulation and motor rehabilitation are thought to share similar mechanisms in inducing neuroplastic changes in the human cortex and an emerging field of research is focusing on the possibility of coupling both therapies in order to achieve an additive effect and improve outcome.
We hypothesize that coupling bihemispheric transcranial direct current stimulation (tDCS) with simultaneous physical/occupational therapy in the subacute phase of ischemic stroke patients may improve upper limb motor recovery in humans.
This is a randomized, controlled, double blind, cross-over, multicentre, clinical trial. Thirty-six ischemic stroke patients in the subacute phase will be recruited in three centers of neurorehabilitation in Switzerland. After stratification based on the Fugl-Meyer Assessment Upper Extremity according to the severity of the deficit, the patient will be randomized to receive besides standardized physical/occupational treatment according to the Impairment-Oriented Training, tDCS of themotor cortex (1.5 mA, 30 minutes) (group 1: 12 patients) or sham stimulation (without current) (group 2: 12 patients). After three weeks of treatment group 1 and 2 will cross-over and will be treated for other three weeks. Group 3 (12 patients) will receive routine physical/occupational treatment and sham tDCS for six weeks. Assessment will be performed before starting tDCS, at week 3, 6 and at 6 months. Outcome measures are the Fugl-Meyer Assessment Upper Extremity, the extended Barthel Index, the Ashworth scale, the Test of Upper Limb Apraxia (only baseline, week 6, month6), the grip strength evaluated by the Jamar Hydraulic Hand dynamometer. At baseline at week 6 and at month 6 depression will be assessed by the Hamilton depression Rating Scale.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 tDCS-Sham | Experimental | Procedure: transcranial direct current stimulation (tDCS)tDC stimulation for 3 weeks, then cross-over to sham stimulation |
| 2 Sham-tDCS | Experimental | Procedure: Sham stimulation, then tDCSSham stimulation for 3 weeks, then cross over to tDCS stimulation |
| 3 Sham-Sham | Sham comparator | Procedure: Sham stimulationTreatment for 6 weeks daily with sham stimulation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Ischemic lesions in the territory of middle cerebral artery subcortical or subcortical/cortical confirmed neuroimaging
- Inclusion must be in the sub-acute phase defined as within 2-4 weeks after stroke
- Persistent hemiparesis, indicated by a score of 1-3 on the motor arm item of the NIH Stroke Scale (NIHSS) (Brott et al. 1989) but wrist and finger movement is not required
- No UE injury or conditions that limited use prior to the stroke.
- The patient is >18 years old.
Key exclusion criteria (6 listed)
- History of epilepsy, brain tumor, major head trauma, learning disorder, severe cognitive impairment, drug or alcohol abuse, major psychiatric illness
- Use of medications that may lower seizure threshold (e.g., metronidazole, fluoroquinolones)
- Severe pain in the affected upper limb (>=8 on the shoulder item of the "joint pain during passive motion" of the Fugl-Meyer Assessment Upper Extremity)
- Further stroke or other significant medical complication during the study
- Evidence of severe leucoencephalopathy (grade IV according to the Fazeka's scale)
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 |
|---|---|---|
| transcranial direct current stimulation (tDCS)Anodal tDCS of the ipsilesional motor cortex and cathodal tDCS of contralesional motor cortex (1.5 mA, 30 minutes) for 15 days during three weeks, then sham stimulation for 30 seconds on 15 days during 3 weeks | Procedure or surgery | 1 tDCS-Sham |
| Sham stimulation, then tDCSSham stimulation for 30 seconds on 15 days during 3 weeks, then anodal tDCS of the ipsilesional motor cortex and cathodal tDCS of contralesional motor cortex (1.5 mA, 30 minutes) for 15 days during three weeks | Procedure or surgery | 2 Sham-tDCS |
| Sham stimulationSham stimulation for 30 seconds on 15 days during 6 weeks | Procedure or surgery | 3 Sham-Sham |
Primary outcome
Fugl-Meyer Assessment Upper Extremity
Time frame: 6 weeks
Investigator administered questionnaire
15 secondary outcomes
Fugl-Meyer Assessment Upper Extremity
Time frame: 3 weeks
Fugl-Meyer Assessment Upper Extremity
Time frame: 6 months
Barthel Index
Time frame: 3 weeks
Barthel Index
Time frame: 6 weeks
Barthel Index
Time frame: 6 months
Ashworth scale
Time frame: 3 weeks
Ashworth scale
Time frame: 6 weeks
Ashworth scale
Time frame: 6 months
Test of Upper Limb Apraxia (TULIA)
Time frame: 6 weeks
Test of Upper Limb Apraxia (TULIA)
Time frame: 6 months
Grip strength
Time frame: 3 weeks
Grip strength
Time frame: 6 weeks
Grip strength
Time frame: 6 months
Hamilton depression Rating scale
Time frame: 6 weeks
Hamilton depression Rating scale
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2017.
- Background: PubMed 21068427Lindenberg R, Renga V, Zhu LL, Nair D, Schlaug G. Bihemispheric brain stimulation facilitates motor recovery in chronic stroke patients. Neurology. 2010 Dec 14;75(24):2176-84. doi: 10.1212/WNL.0b013e318202013a. Epub 2010 Nov 10.
- Derived from this study: PubMed 33175411Elsner B, Kugler J, Pohl M, Mehrholz J. Transcranial direct current stimulation (tDCS) for improving activities of daily living, and physical and cognitive functioning, in people after stroke. Cochrane Database Syst Rev. 2020 Nov 11;11(11):CD009645. doi: 10.1002/14651858.CD009645.pub4.
- Link to the hospital coordinating the studyLink provided by the sponsor.
- Link to the hospital participating in the studyLink provided by the sponsor.
- Link to the clinic participating in the studyLink provided by the sponsor.
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.
Carlo Cereda, MD principal investigator
Ospedale Regionale di Lugano - Civico
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing transcranial direct current stimulation (tDCS) in people with First Ever Clinical Stroke and Ischemic Stroke, run by Dr. med. Carlo Cereda at 3 sites 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 6 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 19 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Carlo Cereda, MD (+41 91 811 66 91, Carlo.Cereda@eoc.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fugl-Meyer Assessment Upper Extremity (time frame: 6 weeks). 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 NCT01644929, 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 19 Sep 2017.