StrokeESTCORMNCT03342534
Effect of tDCS on Brain Organization and Motor Recovery
A study testing DC-stimulator (Neuroconn, Germany) in people with Stroke, run by Adrian Guggisberg at 2 sites in Switzerland.
Trial summary
Neurological deficits and motor disorders are extremely common after stroke. Physical therapies can improve the autonomy of these patients, but despite an intensive stationary neurorehabilitation, severe deficits often persist. Complementary therapies that could improve recovery would therefore be very welcome. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- DC-stimulator (Neuroconn, Germany)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 2 sitesSwitzerland
- Study dates
- 13 Nov 2017to 30 Sep 2024
- 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 or hemorrhagic stroke
- ≤ 4 weeks after stroke onset
- Paresis of upper limb with Fugl-Meyer score between 15 and 55 at study entry
- Capable of participating during treatment sessions of 30-60 minutes
- Informed consent obtained
Who cannot join
- Incapacity to understand study information or task instructions during trial.
- New additional stroke during rehabilitation
- Reduced vigilance or delirium
- Severe language deficits
- Preexisting affection of an upper limb
- Severe spasticity or dystonia
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- Severe co-morbidities (e.g., traumatic, rheumatologic, neurodegenerative disease)
- Pregnancy
- Pacemaker
- Skull breach
- History of seizures or epilepsy
- Metallic object in the brain
- Other contraindication to non-invasive brain stimulation
Trial locations and contacts
2 sites in 1 country.
Switzerland2 sites
Universitäre Neurorehabilitation, Inselspital
Bern, 3010
Division of Neurorehabilitation, University Hospital of Geneva
Geneva, Canton of Geneva, 1211
About this study
Official title: Effects of Transcranial Direct Current Stimulation (tDCS) on Brain Organization and Motor Recovery After Stroke
Neurological deficits and motor disorders are extremely common after stroke. Physical therapies can improve the autonomy of these patients, but despite an intensive stationary neurorehabilitation, severe deficits often persist. Complementary therapies that could improve recovery would therefore be very welcome.
Transcranial direct current stimulation (tDCS) induces, in a non-invasive way, a transient inhibitory or excitatory neuromodulation of certain cerebral regions. An increasing number of studies show that this modulation of brain activity can improve motor functions in patients with brain lesions and increase the effect of physical therapies. However, the "optimum" configuration of tDCS and the induced effects remain to be characterized and investigated.
The investigators therefore propose to carry out a study including a pilot phase in order to determine the most efficient tDCS setup. The optimum setup of of the pilot phase will be compared to a placebo condition in a multicentric main study.
- Conditions
- Stroke
- Being tested
- DC-stimulator (Neuroconn, Germany)
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DC-stimulator (Neuroconn, Germany)Device
A current of 2 mA will be applied for 20 minutes, 3 times per week during 2 weeks, except for the sham tDCS arm.
| Study group | Role | What they receive |
|---|---|---|
| Anodal tDCS | Active comparator | The anode is placed over the primary motor cortex of the stroke affected hemisphere, the cathode over the contralesional supraorbital front of the patient. Receives: Device: DC-stimulator (Neuroconn, Germany) |
| High definition (HD) anodal tDCS | Active comparator | A single HD anode is placed over the primary motor cortex of the stroke affected hemisphere, 4 HD cathodes are placed over the affected hemisphere around the anode. Receives: Device: DC-stimulator (Neuroconn, Germany) |
| Bihemispheric tDCS | Active comparator | The anode is placed over the primary motor cortex of the stroke affected hemisphere, the cathode over the primary motor cortex of the contralesional hemisphere. Receives: Device: DC-stimulator (Neuroconn, Germany) |
| Sham tDCS | Sham comparator | The electrodes are placed as in one of the active arms, but only a ramp up current is applied during 30 seconds and then switched off. This induces similar sensations for the patients, but no change in excitability. Receives: Device: DC-stimulator (Neuroconn, Germany) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in upper extremity Fugl-Meyer score, after intervention
Scale range 0-66 points, higher values indicate better outcome. Assessed by qualified physical or occupational therapists
Measured: Difference between the week before the intervention and the week after intervention
Secondary outcomes (2)
Change in EEG functional connectivity, after intervention
EEG functional connectivity between ipsilesional motor cortex and the rest of the brain, as computed from high-density EEG recordings. Continuous measure. Higher values indicate better outcome.
Measured: Difference between the week before the intervention and the week after intervention
Change in amplitude of motor evoked potentials, after intervention
Motor evoked potentials are obtained with single-pulse transcranial magnetic stimulation. Continuous measure expressed in microvolts, more microvolts indicate better outcome.
Measured: Difference between the week before the intervention and the week after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2017
- Study start13 Nov 2017
- Primary completion30 Apr 2024
- Study completion30 Sep 2024
Why it stopped: End of funds before obtaining the planned number of patients.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Adrian Guggisberg
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Geneva, Clinique Romande de Readaptation, Ecole Polytechnique Fédérale de Lausanne
- Responsible party
- Sponsor-investigator, Adrian Guggisberg, University Hospital, Geneva
- Investigators
- Adrian G Guggisberg, MD, Principal investigator, University of Geneva, SwitzerlandJosé Millán, PhD, Study director, University of Texas at Austin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03342534
- Sponsor's protocol ID
- CRSII5-170985A
- Acronym
- ESTCORM
- Status last verified
- Jun 2025
- First submitted
- 6 Nov 2017
- Last updated
- 11 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Transcranial Direct Current Stimulation (tDCS) on Brain Organization and Motor Recovery After Stroke
- ClinicalTrials.gov ID
- NCT03342534
- Acronym / sponsor ID
- ESTCORM / CRSII5-170985A
- Conditions
- Stroke
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: End of funds before obtaining the planned number of patients.
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Adrian GuggisbergUniversity, hospital or other
- Collaborators
- University Hospital, Geneva, Clinique Romande de Readaptation, Ecole Polytechnique Fédérale de Lausanne
- Study start
- 13 Nov 2017 (actual)
- Primary completion
- 30 Apr 2024 (actual)
- Study completion
- 30 Sep 2024 (actual)
- First posted
- 17 Nov 2017 (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.
Neurological deficits and motor disorders are extremely common after stroke. Physical therapies can improve the autonomy of these patients, but despite an intensive stationary neurorehabilitation, severe deficits often persist. Complementary therapies that could improve recovery would therefore be very welcome.
Transcranial direct current stimulation (tDCS) induces, in a non-invasive way, a transient inhibitory or excitatory neuromodulation of certain cerebral regions. An increasing number of studies show that this modulation of brain activity can improve motor functions in patients with brain lesions and increase the effect of physical therapies. However, the "optimum" configuration of tDCS and the induced effects remain to be characterized and investigated.
The investigators therefore propose to carry out a study including a pilot phase in order to determine the most efficient tDCS setup. The optimum setup of of the pilot phase will be compared to a placebo condition in a multicentric main study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Anodal tDCS | Active comparator | Device: DC-stimulator (Neuroconn, Germany)The anode is placed over the primary motor cortex of the stroke affected hemisphere, the cathode over the contralesional supraorbital front of the patient. |
| High definition (HD) anodal tDCS | Active comparator | Device: DC-stimulator (Neuroconn, Germany)A single HD anode is placed over the primary motor cortex of the stroke affected hemisphere, 4 HD cathodes are placed over the affected hemisphere around the anode. |
| Bihemispheric tDCS | Active comparator | Device: DC-stimulator (Neuroconn, Germany)The anode is placed over the primary motor cortex of the stroke affected hemisphere, the cathode over the primary motor cortex of the contralesional hemisphere. |
| Sham tDCS | Sham comparator | Device: DC-stimulator (Neuroconn, Germany)The electrodes are placed as in one of the active arms, but only a ramp up current is applied during 30 seconds and then switched off. This induces similar sensations for the patients, but no change in excitability. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Ischemic or hemorrhagic stroke
- ≤ 4 weeks after stroke onset
- Paresis of upper limb with Fugl-Meyer score between 15 and 55 at study entry
- Capable of participating during treatment sessions of 30-60 minutes
- Informed consent obtained
Key exclusion criteria (13 listed)
- Incapacity to understand study information or task instructions during trial.
- New additional stroke during rehabilitation
- Reduced vigilance or delirium
- Severe language deficits
- Preexisting affection of an upper limb
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 |
|---|---|---|
| DC-stimulator (Neuroconn, Germany)A current of 2 mA will be applied for 20 minutes, 3 times per week during 2 weeks, except for the sham tDCS arm. | Device | Anodal tDCS, Bihemispheric tDCS, High definition (HD) anodal tDCS, Sham tDCS |
Primary outcome
Change in upper extremity Fugl-Meyer score, after intervention
Time frame: Difference between the week before the intervention and the week after intervention
Scale range 0-66 points, higher values indicate better outcome. Assessed by qualified physical or occupational therapists
2 secondary outcomes
Change in EEG functional connectivity, after intervention
Time frame: Difference between the week before the intervention and the week after intervention
Change in amplitude of motor evoked potentials, after intervention
Time frame: Difference between the week before the intervention and the week after intervention
Results and safety
The study was stopped early (reason given: End of funds before obtaining the planned number of patients.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2025.
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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.
Adrian G Guggisberg, MD principal investigator
University of Geneva, Switzerland
José Millán, PhD study director
University of Texas at Austin
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DC-stimulator (Neuroconn, Germany) in people with Stroke, run by Adrian Guggisberg at 2 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 5 inclusion and 13 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: stopped early, as of the sponsor's last update on 11 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
The study was stopped early (reason given: End of funds before obtaining the planned number of patients.). Results are not available in the source record.
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 upper extremity Fugl-Meyer score, after intervention (time frame: Difference between the week before the intervention and the week after intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Jun 2025.