Effect of tDCS on Brain Organization and Motor Recovery

Stroke Clinical Trial

— ESTCORM  

Official title:

Effects of Transcranial Direct Current Stimulation (tDCS) on Brain Organization and Motor Recovery After Stroke

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03342534
• Other study ID #: CRSII5-170985A
• Status: Recruiting
• Phase: N/A
• Start date: November 13, 2017
• Est. completion date: September 30, 2024

Study information

• Verified date: November 2023
• Source: University Hospital, Geneva
• Contact: Adrian G Guggisberg, MD
• Phone: +41223723521
• Email: Adrian.Guggisberg[@]hcuge.ch
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 44
• Est. completion date: September 30, 2024
• Est. primary completion date: August 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Stroke

Intervention

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.

Locations

Country	Name	City	State
Switzerland	Division of Neurorehabilitation, University Hospital of Geneva	Geneva	GE

Sponsors (4)

Lead Sponsor	Collaborator
Adrian Guggisberg	Clinique Romande de Readaptation, Ecole Polytechnique Fédérale de Lausanne, University Hospital, Geneva

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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	Difference between the week before intervention and 4 weeks after intervention
Other	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	Difference between the week before intervention and 12 weeks after stroke onset
Other	Change in Jamar dynamometer, after intervention	Continous measure expressed in kilograms. Higher values indicate better outcome. Assessed by qualified physical or occupational therapists	Difference between the week before the intervention and the week after intervention
Other	Change in Jamar dynamometer, follow up 1	Continous measure expressed in kilograms. Higher values indicate better outcome. Assessed by qualified physical or occupational therapists	Difference between the week before intervention and 4 weeks after intervention
Other	Change in Jamar dynamometer, follow up 2	Continous measure expressed in kilograms. Higher values indicate better outcome. Assessed by qualified physical or occupational therapists	Difference between the week before intervention and 12 weeks after stroke onset
Other	Change in Nine-Hole-Peg test, after intervention	Expressed in pegs/second. Higher values indicate better outcome. Assessed by qualified physical or occupational therapists.	Difference between the week before the intervention and the week after intervention
Other	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.	Difference between the week before intervention and 4 weeks after intervention
Other	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.	Difference between the week before intervention and 12 weeks after stroke onset
Other	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	Difference between the week before the intervention and the week after intervention
Other	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	Difference between the week before intervention and 4 weeks after intervention
Other	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	Difference between the week before intervention and 12 weeks after stroke onset
Other	Change in Functional Independence Measure (FIM) score, after intervention	Range 18-126, higher values indicate better outcome. Assessed by rehabilitation nurses.	Difference between the week before the intervention and the week after intervention
Other	Change in Functional Independence Measure (FIM) score, follow up 1	Range 18-126, higher values indicate better outcome. Assessed by rehabilitation nurses.	Difference between the week before intervention and 4 weeks after intervention
Other	Change in Functional Independence Measure (FIM) score, follow up 2	Range 18-126, higher values indicate better outcome. Assessed by rehabilitation nurses.	Difference between the week before intervention and 12 weeks after stroke onset
Primary	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	Difference between the week before the intervention and the week after intervention
Secondary	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.	Difference between the week before the intervention and the week after intervention
Secondary	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.	Difference between the week before the intervention and the week after intervention