Rehabilitation Combined With Bihemispherictranscranial Direct Current Stimulation in Subacute Ischemic Stroke

NCT01644929 | Unknown DMC

• 1 other identifier: EOC.NSI.11.02
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 3

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.

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

Outcome Measures

Primary Outcomes (1)

• Fugl-Meyer Assessment Upper Extremity

  Investigator administered questionnaire

  6 weeks

Secondary Outcomes (15)

• Fugl-Meyer Assessment Upper Extremity

  3 weeks

• Fugl-Meyer Assessment Upper Extremity

  6 months

• Barthel Index

  3 weeks

• Barthel Index

  6 weeks

• Barthel Index

  6 months

Study Arms (3)

1 tDCS-Sham

EXPERIMENTAL

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

Procedure: transcranial direct current stimulation (tDCS)

2 Sham-tDCS

EXPERIMENTAL

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

Procedure: Sham stimulation, then tDCS

3 Sham-Sham

SHAM COMPARATOR

Treatment for 6 weeks daily with sham stimulation

Procedure: Sham stimulation

Interventions

transcranial direct current stimulation (tDCS) PROCEDURE

Anodal tDCS of the ipsilesional motor cortex and cathodal tDCS of contralesional motor cortex (1.5 mA, 30 minutes) for 15 days during three weeks, then sham stimulation for 30 seconds on 15 days during 3 weeks

1 tDCS-Sham

Sham stimulation, then tDCS PROCEDURE

Sham stimulation for 30 seconds on 15 days during 3 weeks, then anodal tDCS of the ipsilesional motor cortex and cathodal tDCS of contralesional motor cortex (1.5 mA, 30 minutes) for 15 days during three weeks

2 Sham-tDCS

Sham stimulation PROCEDURE

Sham stimulation for 30 seconds on 15 days during 6 weeks

3 Sham-Sham

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Ischemic lesions in the territory of middle cerebral artery subcortical or subcortical/cortical confirmed neuroimaging
• 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
• No UE injury or conditions that limited use prior to the stroke.
• The patient is \>18 years old.
• The patient has subscribed the informed consent

You may not qualify if:

• History of epilepsy, brain tumor, major head trauma, learning disorder, severe cognitive impairment, drug or alcohol abuse, major psychiatric illness
• Use of medications that may lower seizure threshold (e.g., metronidazole, fluoroquinolones)
• 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)
• Further stroke or other significant medical complication during the study
• Evidence of severe leucoencephalopathy (grade IV according to the Fazeka's scale)
• Important aphasia that would impair the understanding and performance of the assessment scales

Sponsors & Collaborators

• Dr. med. Carlo Cereda: lead
• Insel Gruppe AG, University Hospital Bern: collaborator
• Clinica Hildebrand Brissago: collaborator
• Advisory Board Research Ente Ospedaliero Cantonale: collaborator

Study Sites (3)

Universitätsspital Bern, Inselspital, Neuropsychologische Rehabilitation

Bern, 3010, Switzerland

WITHDRAWN

Clinica Hildebrand, Centro di riabilitazione Brissago

Brissago, 6614, Switzerland

RECRUITING

HELIOS Klinik Zihlschlacht AG, Neurologisches Rehabilitationszentrum

Zihlschlacht, 8588, Switzerland

TERMINATED

Related Publications (2)

• 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.

  PMID: 21068427 BACKGROUND

• 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.

  PMID: 33175411 DERIVED

Related Links

• Link to the hospital coordinating the study
• Link to the hospital participating in the study
• Link to the clinic participating in the study

MeSH Terms

Conditions

Ischemic Stroke; Paresis

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Study Officials

• Carlo Cereda, MD

  Ospedale Regionale di Lugano - Civico

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Carlo Cereda, MD

CONTACT

+41 91 811 66 91; Carlo.Cereda@eoc.ch

Paolo Rossi, MD

CONTACT

+41 091 786 86 86; paolo.rossi@clinica-hildebrand.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Capo clinica

Study Record Dates

• First Submitted: July 17, 2012
• First Posted: July 19, 2012
• Study Start: March 1, 2013
• Primary Completion: February 1, 2018
• Study Completion: February 1, 2018
• Last Updated: September 19, 2017

Record last verified: 2017-09

Locations

CH (3)