ClinicalTrials.gg
TerminatedNCT03342534ESTCORMUpdated Jun 11, 2025

Effect of tDCS on Brain Organization and Motor Recovery

An interventional study of DC-stimulator (Neuroconn, Germany) in Stroke, sponsored by Adrian Guggisberg. Terminated at 2 sites in Switzerland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-06-11.

Sponsored by Adrian Guggisberg · Not applicable, Interventional, and Treatment

Why this study was terminated
End of funds before obtaining the planned number of patients.
Phase
Not applicable
Study type
Interventional
Enrollment
36
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

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.

02

Conditions studied

  • Stroke

Browse trials for

03

In context

Stroke

8,255 studies on the registry are indexed under Stroke; 2,056 are open to participants now.

This study's enrollment of 36 is below the median of 49 across 6,024 interventional studies indexed under Stroke.

Browse Stroke studies →

Lead sponsor

Adrian Guggisberg is the lead sponsor of 5 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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
  • obtained

Exclusion criteria

Exclusion Criteria:

  • 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
  • Severe co-morbidities (e.g., traumatic, rheumatologic, neurodegenerative disease)
  • Pregnancy
  • Pacemaker
  • Skull breach
  • History of seizures or epilepsy
  • Metallic object in the brain
  • Other to non-invasive brain stimulation
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Outcomes assessor)
Enrollment
36 participants (actual)

Study arms

  • Active comparator
    Anodal tDCS

    The anode is placed over the primary motor cortex of the stroke affected hemisphere, the cathode over the contralesional supraorbital front of the patient.

    Device: DC-stimulator (Neuroconn, Germany)

  • Active comparator
    High definition (HD) anodal tDCS

    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.

    Device: DC-stimulator (Neuroconn, Germany)

  • Active comparator
    Bihemispheric tDCS

    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.

    Device: DC-stimulator (Neuroconn, Germany)

  • Sham comparator
    Sham tDCS

    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.

    Device: DC-stimulator (Neuroconn, Germany)

Interventions

  • DeviceDC-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.

06

What researchers measure

Primary outcomes

  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

    Time frame: Difference between the week before the intervention and the week after intervention

Secondary outcomes

  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.

    Time frame: 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.

    Time frame: Difference between the week before the intervention and the week after intervention

Other outcomes

  1. Change in upper extremity Fugl-Meyer score, follow up 1

    Scale range 0-66 points, higher values indicate better outcome. Assessed by qualified physical or occupational therapists

    Time frame: Difference between the week before intervention and 4 weeks after intervention

  2. Change in upper extremity Fugl-Meyer score, follow up 2

    Scale range 0-66 points, higher values indicate better outcome. Assessed by qualified physical or occupational therapists

    Time frame: Difference between the week before intervention and 12 weeks after stroke onset

  3. Change in Jamar dynamometer, after intervention

    Continous measure expressed in kilograms. Higher values indicate better outcome. Assessed by qualified physical or occupational therapists

    Time frame: Difference between the week before the intervention and the week after intervention

  4. Change in Jamar dynamometer, follow up 1

    Continous measure expressed in kilograms. Higher values indicate better outcome. Assessed by qualified physical or occupational therapists

    Time frame: Difference between the week before intervention and 4 weeks after intervention

  5. Change in Jamar dynamometer, follow up 2

    Continous measure expressed in kilograms. Higher values indicate better outcome. Assessed by qualified physical or occupational therapists

    Time frame: Difference between the week before intervention and 12 weeks after stroke onset

  6. Change in Nine-Hole-Peg test, after intervention

    Expressed in pegs/second. Higher values indicate better outcome. Assessed by qualified physical or occupational therapists.

    Time frame: Difference between the week before the intervention and the week after intervention

  7. Change in Nine-Hole-Peg test, follow up 1

    Expressed in pegs/second. Higher values indicate better outcome. Assessed by qualified physical or occupational therapists.

    Time frame: Difference between the week before intervention and 4 weeks after intervention

  8. Change in Nine-Hole-Peg test, follow up 2

    Expressed in pegs/second. Higher values indicate better outcome. Assessed by qualified physical or occupational therapists.

    Time frame: Difference between the week before intervention and 12 weeks after stroke onset

  9. Change in action research arm test (ARAT) score, after intervention

    Scale range 0-57 points, higher values indicate better outcome. Assessed by qualified physical or occupational therapists

    Time frame: Difference between the week before the intervention and the week after intervention

  10. Change in action research arm test (ARAT) score, follow up 1

    Scale range 0-57 points, higher values indicate better outcome. Assessed by qualified physical or occupational therapists

    Time frame: Difference between the week before intervention and 4 weeks after intervention

  11. Change in action research arm test (ARAT) score, follow up 2

    Scale range 0-57 points, higher values indicate better outcome. Assessed by qualified physical or occupational therapists

    Time frame: Difference between the week before intervention and 12 weeks after stroke onset

  12. Change in Functional Independence Measure (FIM) score, after intervention

    Range 18-126, higher values indicate better outcome. Assessed by rehabilitation nurses.

    Time frame: Difference between the week before the intervention and the week after intervention

  13. Change in Functional Independence Measure (FIM) score, follow up 1

    Range 18-126, higher values indicate better outcome. Assessed by rehabilitation nurses.

    Time frame: Difference between the week before intervention and 4 weeks after intervention

  14. Change in Functional Independence Measure (FIM) score, follow up 2

    Range 18-126, higher values indicate better outcome. Assessed by rehabilitation nurses.

    Time frame: Difference between the week before intervention and 12 weeks after stroke onset

07

Study locations

2 sites
  • Division of Neurorehabilitation, University Hospital of Geneva
    Geneva, GE 1211, Switzerland
  • Universitäre Neurorehabilitation, Inselspital
    Bern, 3010, Switzerland
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Nov 2017 to primary completion in Apr 2024, 77 months.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 6, 2017
First posted
Nov 17, 2017
StartActual
Nov 13, 2017
Primary completionActual
Apr 30, 2024
CompletionActual
Sep 30, 2024
Last update
Jun 11, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 11, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03342534
Lead sponsor
Adrian Guggisberg
Collaborators
University Hospital, Geneva, Clinique Romande de Readaptation, Ecole Polytechnique Fédérale de Lausanne
Responsible party
Adrian Guggisberg (Médecin adjoint agrégé, assistant professor, University Hospital, Geneva) — Sponsor-investigator
First posted
Nov 17, 2017
Start date
Nov 13, 2017
Primary completion
Apr 30, 2024
Completion
Sep 30, 2024
Last update
Jun 11, 2025

Study contacts

Adrian G Guggisberg, MD
principal investigator · University of Geneva
José Millán, PhD
study director · University of Texas - Austin

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Jun 2025. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion