Clinical trial NCT01644929: Rehabilitation Combined With Bihemispherictranscranial Direct Current Stimulation in Subacute Ischemic Stroke
Official title: Rehabilitation Combined With Bihemispherictranscranial Direct Current Stimulation in Subacute Ischemic Stroke to Increase Upper Limb Motor Recovery, a Randomised, Controlled, Double-blind Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: First Ever Clinical Stroke
Ischemic Stroke
Subacute Phase
Persistent Hemiparesis of Upper Extremity
Keywords: hemiparesis
bihemispheric transcranial direct current stimulation
ischemic stroke
subacute
rehabilitation
physiotherapy
ergotherapy
Lead sponsor: Ospedale Civico, Lugano
Sponsor class: OTHER_GOV
Collaborators: name: Insel Gruppe AG, University Hospital Bern
name: Clinica Hildebrand Brissago
name: Advisory Board Research Ente Ospedaliero Cantonale
First posted: 2012-07-19
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: Rehabilitation after stroke improves motor functions by promoting plastic changes however, after completing standard rehabilitation, 50-60% of patients still exhibit some degree of motor impairment and require at least partial assistance in activities of day living. Therefore, the exploration of other approaches to promote recovery is compulsory. Non invasive brain stimulation and motor rehabilitation are thought to share similar mechanisms in inducing neuroplastic changes in the human cortex and an emerging field of research is focusing on the possibility of coupling both therapies in order to achieve an additive effect and improve outcome.

We hypothesize that coupling bihemispheric transcranial direct current stimulation (tDCS) with simultaneous physical/occupational therapy in the subacute phase of ischemic stroke patients may improve upper limb motor recovery in humans.

This is a randomized, controlled, double blind, cross-over, multicentre, clinical trial. Thirty-six ischemic stroke patients in the subacute phase will be recruited in three centers of neurorehabilitation in Switzerland. After stratification based on the Fugl-Meyer Assessment Upper Extremity according to the severity of the deficit, the patient will be randomized to receive besides standardized physical/occupational treatment according to the Impairment-Oriented Training, tDCS of themotor cortex (1.5 mA, 30 minutes) (group 1: 12 patients) or sham stimulation (without current) (group 2: 12 patients). After three weeks of treatment group 1 and 2 will cross-over and will be treated for other three weeks. Group 3 (12 patients) will receive routine physical/occupational treatment and sham tDCS for six weeks. Assessment will be performed before starting tDCS, at week 3, 6 and at 6 months. Outcome measures are the Fugl-Meyer Assessment Upper Extremity, the extended Barthel Index, the Ashworth scale, the Test of Upper Limb Apraxia (only baseline, week 6, month6), the grip strength evaluated by the Jamar Hydraulic Hand dynamometer. At baseline at week 6 and at month 6 depression will be assessed by the Hamilton depression Rating Scale.


Eligibility criteria: Inclusion Criteria:

1. Ischemic lesions in the territory of middle cerebral artery subcortical or subcortical/cortical confirmed neuroimaging
2. Inclusion must be in the sub-acute phase defined as within 2-4 weeks after stroke
3. Persistent hemiparesis, indicated by a score of 1-3 on the motor arm item of the NIH Stroke Scale (NIHSS) (Brott et al. 1989) but wrist and finger movement is not required
4. No UE injury or conditions that limited use prior to the stroke.
5. The patient is \>18 years old.
6. The patient has subscribed the informed consent

Exclusion Criteria:

1. History of epilepsy, brain tumor, major head trauma, learning disorder, severe cognitive impairment, drug or alcohol abuse, major psychiatric illness
2. Use of medications that may lower seizure threshold (e.g., metronidazole, fluoroquinolones)
3. Severe pain in the affected upper limb (\>=8 on the shoulder item of the "joint pain during passive motion" of the Fugl-Meyer Assessment Upper Extremity)
4. Further stroke or other significant medical complication during the study
5. Evidence of severe leucoencephalopathy (grade IV according to the Fazeka's scale)
6. Important aphasia that would impair the understanding and performance of the assessment scales

Primary outcomes:
measure: Fugl-Meyer Assessment Upper Extremity
timeFrame: 6 weeks
Secondary outcomes:
measure: Fugl-Meyer Assessment Upper Extremity
timeFrame: 3 weeks
measure: Fugl-Meyer Assessment Upper Extremity
timeFrame: 6 months
measure: Barthel Index
timeFrame: 3 weeks
measure: Barthel Index
timeFrame: 6 weeks
measure: Barthel Index
timeFrame: 6 months
measure: Ashworth scale
timeFrame: 3 weeks
measure: Ashworth scale
timeFrame: 6 weeks
measure: Ashworth scale
timeFrame: 6 months
measure: Test of Upper Limb Apraxia (TULIA)
timeFrame: 6 weeks
measure: Test of Upper Limb Apraxia (TULIA)
timeFrame: 6 months
measure: Grip strength
timeFrame: 3 weeks
measure: Grip strength
timeFrame: 6 weeks
measure: Grip strength
timeFrame: 6 months
measure: Hamilton depression Rating scale
timeFrame: 6 weeks
measure: Hamilton depression Rating scale
timeFrame: 6 months
Other outcomes:
Locations:
city: Bern
country: Switzerland
facility: Universitätsspital Bern, Inselspital, Neuropsychologische Rehabilitation
city: Brissago
country: Switzerland
facility: Clinica Hildebrand, Centro di riabilitazione Brissago
city: Zihlschlacht
country: Switzerland
facility: HELIOS Klinik Zihlschlacht AG, Neurologisches Rehabilitationszentrum
Study officials:
affiliation: Ospedale Regionale di Lugano - Civico
name: Carlo Cereda, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lindenberg R, Renga V, Zhu LL, Nair D, Schlaug G. Bihemispheric brain stimulation facilitates motor recovery in chronic stroke patients. Neurology. 2010 Dec 14;75(24):2176-84. doi: 10.1212/WNL.0b013e318202013a. Epub 2010 Nov 10.
citation: Elsner B, Kugler J, Pohl M, Mehrholz J. Transcranial direct current stimulation (tDCS) for improving activities of daily living, and physical and cognitive functioning, in people after stroke. Cochrane Database Syst Rev. 2020 Nov 11;11(11):CD009645. doi: 10.1002/14651858.CD009645.pub4.