Rehabilitation Combined With Bihemispherictranscranial Direct Current Stimulation in Subacute Ischemic Stroke (RECOMBINE)

Dr. med. Carlo Cereda

Status: Unknown

Conditions: Ischemic Stroke; Persistent Hemiparesis of Upper Extremity; First Ever Clinical Stroke; Subacute Phase

Treatments: Procedure: transcranial direct current stimulation (tDCS); Procedure: Sham stimulation; Procedure: Sham stimulation, then tDCS

Study type: Interventional

Funder types: Other

Identifiers

NCT01644929

EOC.NSI.11.02

Details and patient eligibility

About

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.

Enrollment: 36 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

---

36 participants in 3 patient groups

1 tDCS-Sham

Experimental group

Description:

tDC stimulation for 3 weeks, then cross-over to sham stimulation

Treatment:

Procedure: transcranial direct current stimulation (tDCS)

2 Sham-tDCS

Experimental group

Description:

Sham stimulation for 3 weeks, then cross over to tDCS stimulation

Treatment:

Procedure: Sham stimulation, then tDCS

3 Sham-Sham

Sham Comparator group

Description:

Treatment for 6 weeks daily with sham stimulation

Treatment:

Procedure: Sham stimulation