Clinical trial NCT00909714: Neuroregeneration Enhanced by Transcranial Direct Current Stimulation (TDCS) in Stroke
Official title: Neuroregeneration Enhanced by TDCS in Stroke
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Keywords: stroke
non-invasive cortical stimulation
motor recovery
cortical plasticity
TDCS
Lead sponsor: Universitätsklinikum Hamburg-Eppendorf
Sponsor class: OTHER
First posted: 2009-05-28
Enrollment: 119
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Testing the hypothesis that non-invasive brain stimulation by transcranial direct current stimulation (tDCS) combined with functional training in the subacute phase of first-ever stroke will enhance functional regeneration compared with a Placebo intervention.

Detailed description: Stroke is the leading cause of long-term disability, which significantly impairs the economic and social life of patients and society. Every year 200 000 to 250 000 patients suffer a stroke in Germany. Only a small number of the stroke survivors recover to a degree that allows them to return into their professional and private life. Despite significant efforts to develop novel and efficient treatment strategies the level of functional regeneration is still not satisfying. Thus, the development of innovative and effective treatment strategies will have a major impact for the patients' life, the society and the public health system.

Within the proposed project an innovative, non-invasive and cost effective interventional strategy, based on the combination of a specific rehabilitative training and brain stimulation by transcranial direct current stimulation (tDCS), will be used to enhance functional regeneration in stroke patients. The intervention will be applied in an early stage in which plasticity, cortical reorganization and functional improvement is most pronounced. We hypothesize that the combination of anodal tDCS delivered to the motor cortex of the affected hemisphere combined with training over a period of two weeks in the subacute stage after stroke will significantly enhance cortical plasticity, functional regeneration and long-term outcome determined by clinical and functional outcome measures compared with Placebo stimulation.

Eligibility criteria: Inclusion Criteria:

* Subacute stroke patients (5-45 days after stroke) with thromboembolic non-hemorrhagic subcortical or cortical, first clinically overt stroke will be included. Moderate to moderately severe upper-extremity hemiparesis, defined as an Upper Extremity Fugl-Meyer score (UEFMA) between 20 and 58 (inclusive).

Exclusion Criteria:

* pre-existing large lesions (\> 1.5 cm maximum diameter) in a brain area that belongs to the anatomically established sensorimotor/premotor system
* progressive stroke
* completely lesioned hand knob area of M1 affected if no motor evoked potentials (MEPs) elicited by transcranial magnetic stimulation (TMS) are present
* bilateral motor impairment
* florid alcohol and/or drug abuse
* florid severe psychiatric illness (e.g. schizophrenia)
* severe language disturbances that prevents the patient to give informed consent or inhibit adequate scoring because of insufficient understanding of scoring introductions
* tumor diseases with a life expectancy less than one year
* increased intracranial pressure
* polyneuropathy and/or ischemic peripheral disease if the sensorimotor functions of the upper extremities are affected clinically relevant
* severe cognitive deficits (MMSE ≤ 23)
* pregnancy
* contraindication for MRI or TMS

Primary outcomes:
measure: Upper Extremity Fugl-Meyer-Assessment (UEFMA)
timeFrame: 1-7 days after the end of the intervention
Secondary outcomes:
measure: Upper Extremity Fugl-Meyer-Assessment (UEFMA)
timeFrame: 30±10 days after the intervention
measure: Upper Extremity Fugl-Meyer-Assessment (UEFMA)
timeFrame: 90±20 days after the intervention
measure: Upper Extremity Fugl-Meyer-Assessment (UEFMA) | Long-term outcome
timeFrame: 12±1 months after the intervention
measure: Action Research Arm Test (ARAT)
timeFrame: 1-7 days after the end of the intervention
measure: Action Research Arm Test (ARAT)
timeFrame: 30±10 days after the intervention
measure: Action Research Arm Test (ARAT)
timeFrame: 90±20 days after the intervention
measure: Action Research Arm Test (ARAT) | Long-term outcome
timeFrame: 12±1 months after the intervention
measure: Nine Hole Peg Test (NHPT)
timeFrame: 1-7 days after the end of the intervention
measure: Nine Hole Peg Test (NHPT)
timeFrame: 30±10 days after the intervention
measure: Nine Hole Peg Test (NHPT)
timeFrame: 90±20 days after the intervention
measure: Nine Hole Peg Test (NHPT) | Long-term outcome
timeFrame: 12±1 months after the intervention
measure: Stroke Impact Scale (SIS)
timeFrame: 1-7 days after the end of the intervention
measure: Stroke Impact Scale (SIS)
timeFrame: 30±10 days after the intervention
measure: Stroke Impact Scale (SIS)
timeFrame: 90±20 days after the intervention
measure: Stroke Impact Scale (SIS) | Long-term outcome
timeFrame: 12±1 months after the intervention
measure: Box-and-Block Test
timeFrame: 1-7 days after the end of the intervention
measure: Box-and-Block Test
timeFrame: 30±10 days after the intervention
measure: Box-and-Block Test
timeFrame: 90±20 days after the intervention
measure: Box-and-Block Test
timeFrame: 12±1 months after the intervention
measure: Grip Force
timeFrame: 1-7 days after the end of the intervention
measure: Grip Force
timeFrame: 30±10 days after the intervention
measure: Grip Force
timeFrame: 90±20 days after the intervention
measure: Grip Force
timeFrame: 12±1 months after the intervention
Other outcomes:
Locations:
city: Wien
country: Austria
facility: Neurologische Universitätsklinik Wien
city: Kipfenberg
country: Germany
facility: Klinik Kipfenberg
state: Bayern
city: Bernau bei Berlin
country: Germany
facility: Brandenburgklinik Berlin-Brandenburg
state: Berlin
city: Bad Klosterlausnitz
country: Germany
facility: Neurologie Moritzklinik
state: Thüringen
city: Bad Aibling
country: Germany
facility: Neurologische Klinik Bad Aibling
city: Bad Segeberg
country: Germany
facility: Neurologisches Zentrum Segeberger Kliniken
city: Bennewitz
country: Germany
facility: NRZ Leipzig
city: Berlin
country: Germany
facility: MEDIAN Klinik Berlin-Kladow
city: Hamburg
country: Germany
facility: University Medical Center Hamburg Eppendorf (UKE)
city: Heidelberg
country: Germany
facility: University Medical Center Heidelberg
city: Rome
country: Italy
facility: Fondazione Santa Lucia
Study officials:
affiliation: Department of Neurology, University Medical Center Hamburg-Eppendorf
name: Christian Gerloff, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: NETS Trial Collaboration Group. A multicenter, randomized, double-blind, placebo-controlled trial to test efficacy and safety of transcranial direct current stimulation to the motor cortex after stroke (NETS): study protocol. Neurol Res Pract. 2022 Apr 18;4(1):14. doi: 10.1186/s42466-022-00171-2.
citation: NETS Trial Collaboration Group. Efficacy and safety of transcranial direct current stimulation to the ipsilesional motor cortex in subacute stroke (NETS): a multicenter, randomized, double-blind, placebo-controlled trial. Lancet Reg Health Eur. 2024 Jan 2;38:100825. doi: 10.1016/j.lanepe.2023.100825. eCollection 2024 Mar.
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.