Effect of tDCS on Brain Organization and Motor Recovery (ESTCORM)

• ClinicalTrials.gov Identifier: NCT03342534
• Recruitment Status: Recruiting
• First Posted: November 17, 2017
• Last Update Posted: October 6, 2021
• Sponsor: Adrian Guggisberg
• Collaborators: University Hospital, Geneva; Clinique Romande de Readaptation; Ecole Polytechnique Fédérale de Lausanne
• Information provided by (Responsible Party): Adrian Guggisberg, University Hospital, Geneva

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
Stroke	Device: DC-stimulator (Neuroconn, Germany)	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 44 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Effects of Transcranial Direct Current Stimulation (tDCS) on Brain Organization and Motor Recovery After Stroke
• Actual Study Start Date: November 13, 2017
• Estimated Primary Completion Date: August 31, 2022
• Estimated Study Completion Date: September 30, 2022

Arms and Interventions

Arm	Intervention/treatment
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); A current of 2 mA will be applied for 20 minutes, 3 times per week during 2 weeks, except for the sham tDCS arm.
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); A current of 2 mA will be applied for 20 minutes, 3 times per week during 2 weeks, except for the sham tDCS arm.
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); A current of 2 mA will be applied for 20 minutes, 3 times per week during 2 weeks, except for the sham tDCS arm.
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); A current of 2 mA will be applied for 20 minutes, 3 times per week during 2 weeks, except for the sham tDCS arm.

Outcome Measures

Primary Outcome Measures :

1. 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

Secondary Outcome Measures :

1. Change in EEG functional connectivity, after intervention [ Time Frame: Difference between the week before the intervention and the week 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.
2. Change in amplitude of motor evoked potentials, after intervention [ Time Frame: Difference between the week before the intervention and the week after intervention ]
   Motor evoked potentials are obtained with single-pulse transcranial magnetic stimulation. Continuous measure expressed in microvolts, more microvolts indicate better outcome.

Other Outcome Measures:

1. Change in upper extremity Fugl-Meyer score, follow up 1 [ Time Frame: Difference between the week before intervention and 4 weeks after intervention ]
   Scale range 0-66 points, higher values indicate better outcome. Assessed by qualified physical or occupational therapists
2. Change in upper extremity Fugl-Meyer score, follow up 2 [ Time Frame: Difference between the week before intervention and 12 weeks after stroke onset ]
   Scale range 0-66 points, higher values indicate better outcome. Assessed by qualified physical or occupational therapists
3. Change in Jamar dynamometer, after intervention [ Time Frame: Difference between the week before the intervention and the week after intervention ]
   Continous measure expressed in kilograms. Higher values indicate better outcome. Assessed by qualified physical or occupational therapists
4. Change in Jamar dynamometer, follow up 1 [ Time Frame: Difference between the week before intervention and 4 weeks after intervention ]
   Continous measure expressed in kilograms. Higher values indicate better outcome. Assessed by qualified physical or occupational therapists
5. Change in Jamar dynamometer, follow up 2 [ Time Frame: Difference between the week before intervention and 12 weeks after stroke onset ]
   Continous measure expressed in kilograms. Higher values indicate better outcome. Assessed by qualified physical or occupational therapists
6. Change in Nine-Hole-Peg test, after intervention [ Time Frame: Difference between the week before the intervention and the week after intervention ]
   Expressed in pegs/second. Higher values indicate better outcome. Assessed by qualified physical or occupational therapists.
7. Change in Nine-Hole-Peg test, follow up 1 [ Time Frame: Difference between the week before intervention and 4 weeks after intervention ]
   Expressed in pegs/second. Higher values indicate better outcome. Assessed by qualified physical or occupational therapists.
8. Change in Nine-Hole-Peg test, follow up 2 [ Time Frame: Difference between the week before intervention and 12 weeks after stroke onset ]
   Expressed in pegs/second. Higher values indicate better outcome. Assessed by qualified physical or occupational therapists.
9. Change in action research arm test (ARAT) score, after intervention [ Time Frame: Difference between the week before the intervention and the week after intervention ]
   Scale range 0-57 points, higher values indicate better outcome. Assessed by qualified physical or occupational therapists
10. Change in action research arm test (ARAT) score, follow up 1 [ Time Frame: Difference between the week before intervention and 4 weeks after intervention ]
    Scale range 0-57 points, higher values indicate better outcome. Assessed by qualified physical or occupational therapists
11. Change in action research arm test (ARAT) score, follow up 2 [ Time Frame: Difference between the week before intervention and 12 weeks after stroke onset ]
    Scale range 0-57 points, higher values indicate better outcome. Assessed by qualified physical or occupational therapists
12. Change in Functional Independence Measure (FIM) score, after intervention [ Time Frame: Difference between the week before the intervention and the week after intervention ]
    Range 18-126, higher values indicate better outcome. Assessed by rehabilitation nurses.
13. Change in Functional Independence Measure (FIM) score, follow up 1 [ Time Frame: Difference between the week before intervention and 4 weeks after intervention ]
    Range 18-126, higher values indicate better outcome. Assessed by rehabilitation nurses.
14. Change in Functional Independence Measure (FIM) score, follow up 2 [ Time Frame: Difference between the week before intervention and 12 weeks after stroke onset ]
    Range 18-126, higher values indicate better outcome. Assessed by rehabilitation nurses.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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
• Informed consent obtained

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 contraindication to non-invasive brain stimulation

Contacts and Locations

Contacts

Contact: Adrian G Guggisberg, MD; +41223723521; Adrian.Guggisberg@hcuge.ch

Contact: José Millán, PhD; jose.millan@epfl.ch

Locations

Switzerland

Division of Neurorehabilitation, University Hospital of Geneva; Recruiting

Geneva, GE, Switzerland, 1211

Contact: Adrian G Guggisberg, MD +41223723521 adrian.guggisberg@hcuge.ch

Principal Investigator: Adrian G Guggisberg, MD

Sponsors and Collaborators

Adrian Guggisberg

University Hospital, Geneva

Clinique Romande de Readaptation

Ecole Polytechnique Fédérale de Lausanne

Investigators

• Principal Investigator: Adrian G Guggisberg, MD; University of Geneva
• Study Director: José Millán, PhD; Ecole Polytechnique Fédérale de Lausanne

More Information

• Responsible Party: Adrian Guggisberg, Médecin adjoint agrégé, assistant professor, University Hospital, Geneva
• ClinicalTrials.gov Identifier: NCT03342534
• Other Study ID Numbers: CRSII5-170985A
• First Posted: November 17, 2017
• Last Update Posted: October 6, 2021
• Last Verified: October 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases