NCT02031107

Brief Summary

Background: Stroke is a leading cause of adult disability. Non-invasive brain stimulation can induce significant and sustained improvements in functional outcome. However the effect is inconsistent and difficult to predict, in particular in the subacute phase after stroke. Although several different stimulation techniques are available, it is unknown which is suitable for which patient. Objectives: This study has three main objectives:

  1. 1.To compare the effects of two techniques of non-invasive brain stimulation (cTBC, continuous theta-burst stimulation; tDCS, direct current transcranial stimulation) on clinical recovery in patients with subacute stroke.
  2. 2.To assess the effect of these brain stimulation techniques on brain organization with non-invasive imaging.
  3. 3.To find clinical and neural predictors of responsiveness to brain stimulation therapy.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
41

participants targeted

Target at P25-P50 for not_applicable stroke

Timeline
Completed

Started Sep 2013

Typical duration for not_applicable stroke

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2013

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 6, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 9, 2014

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2016

Completed
Last Updated

May 12, 2016

Status Verified

May 1, 2016

Enrollment Period

2.5 years

First QC Date

January 6, 2014

Last Update Submit

May 11, 2016

Conditions

Stroke

Keywords

strokebrain stimulationelectroencephalographyfunctional magnetic resonance imagingfunctional connectivity

Outcome Measures

Primary Outcomes (2)

  • Change in compound motor score slope at week 4

    The Fugl Meyer motor assessment (FMA), the Nine Hole Peg test (expressed as pegs per minute), and the Jamar dynamometer strength of the affected arm are normalized to the healthy arm and averaged to a compound motor score. This score is obtained twice before treatment (at weeks -1 and 0 relative to treatment start), and twice after treatment (at weeks 4 and 8). Primary outcome measure is the change in slope from week 0 to 4 as compared to the slope between week -1 and 0.

    week 4 after treatment start

  • Change in alpha-band coherence between the affected motor cortex and the rest of the brain

    Calculated from electroencephalography recordings

    Week 4

Secondary Outcomes (7)

  • Change in Fugl Meyer Upper Extremity Motor Score at week 4

    Week 4

  • Change in Fugl Meyer Upper Extremity Motor Score at week 8

    Week 8

  • Change in alpha-band coherence between the unaffected motor cortex and the rest of the brain

    Week 4

  • Change in activity of daily life scale (motor activity log, MAL)

    Week 4

  • Change in activity of daily life scale (motor activity log, MAL)

    Week 8

  • +2 more secondary outcomes

Other Outcomes (11)

  • Total Fugl Meyer motor assessment score at week 4

    Week 4

  • Total Fugl Meyer motor assessment score at week 8

    Week 8

  • Change in average velocity in the Nine Hole Peg test at week 4

    Week 4

  • +8 more other outcomes

Study Arms (3)

cTBS

ACTIVE COMPARATOR

A transcranial magnetic stimulator (MagPro X100, Medtronic Functional Diagnostics, Skovlunde, Denmark) will deliver continuous bursts of bipolar magnetic pulses exerting an inhibition on the underlying brain tissue (cTBS). The stimulation coil will be placed over the unaffected primary motor cortex. The stimulation protocol implies 200 bursts, each consisting of three pulses applied at 30 Hz, repeated at inter-burst intervals of 167 ms. Two stimulation trains of 30 s, separated by 15 min, will be applied 3 times per week for 3 weeks and will be immediately followed by physical therapy.

Device: cTBS

cathodal tDCS

ACTIVE COMPARATOR

A stimulator (NeuroConn GmbH, Illmenau, Germany) will deliver cathodal transcranial direct current stimulation (tDCS) of the unaffected motor cortex. The anode will be placed over the contralateral supraorbital region. Stimulation will be performed for 25 min, 3 times per week for 3 weeks during upper extremity treatment sessions.

Device: cathodal tDCS

sham stimulation

SHAM COMPARATOR

This group will receive the same stimulation protocol as used for the active groups except that sham stimuli will be applied. Half of the patients receive sham cTBS, the other half sham tDCS.

Device: sham stimulation

Interventions

cTBSDEVICE
Also known as: MagPro X100
cTBS
cathodal tDCSDEVICE
Also known as: NeuroConn
cathodal tDCS
sham stimulationDEVICE
sham stimulation

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • ischemic or hemorrhagic stroke leading to unilateral deficits in motor function with significant impact on independence and daily activities at the beginning of rehabilitation
  • less than 10 weeks after stroke onset.

You may not qualify if:

  • epileptic seizures
  • metallic objects in the brain
  • presence of implants or neural stimulators
  • pregnancy
  • sleep deprivation
  • recent traumatic brain injury
  • delirium or disturbed vigilance
  • inability to participate in 1h treatment sessions
  • severe language comprehension deficits
  • skull breach
  • new stroke lesions during rehabilitation
  • medical complications

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Service de Neurorééducation, Unversity Hospital

Geneva, 1211, Switzerland

Location

Related Publications (2)

  • Rizk S, Ptak R, Nyffeler T, Schnider A, Guggisberg AG. Network mechanisms of responsiveness to continuous theta-burst stimulation. Eur J Neurosci. 2013 Oct;38(8):3230-8. doi: 10.1111/ejn.12334. Epub 2013 Aug 14.

    PMID: 23941616BACKGROUND

  • Nicolo P, Magnin C, Pedrazzini E, Plomp G, Mottaz A, Schnider A, Guggisberg AG. Comparison of Neuroplastic Responses to Cathodal Transcranial Direct Current Stimulation and Continuous Theta Burst Stimulation in Subacute Stroke. Arch Phys Med Rehabil. 2018 May;99(5):862-872.e1. doi: 10.1016/j.apmr.2017.10.026. Epub 2017 Dec 7.

    PMID: 29223708DERIVED

MeSH Terms

Conditions

Stroke

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeuticsConvulsive TherapyPsychiatric Somatic TherapiesBehavioral Disciplines and ActivitiesElectroshockPsychological Techniques

Study Officials

  • Adrian G Guggisberg, MD

    University Hospital, Geneva

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Médecin adjoint agrégé

Study Record Dates

First Submitted

January 6, 2014

First Posted

January 9, 2014

Study Start

September 1, 2013

Primary Completion

March 1, 2016

Study Completion

March 1, 2016

Last Updated

May 12, 2016

Record last verified: 2016-05

Locations

CH(1)