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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.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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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
Show all 13Show fewer
  • 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

Other trials in Switzerland

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 groups in NCT03342534
Study groupRoleWhat they receive
Anodal tDCSActive comparatorThe 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 tDCSActive comparatorA 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 tDCSActive comparatorThe 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 tDCSSham comparatorThe 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.

  1. 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)
  1. 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

  2. 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.

  1. First posted17 Nov 2017
  2. Study start13 Nov 2017
  3. Primary completion30 Apr 2024
  4. Study completion30 Sep 2024

Why it stopped: End of funds before obtaining the planned number of patients.

Resources

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)
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

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.

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