Transcranial direct current stimulation (tDCS): Anodal stimulation or sham
Study summary
The present study will evaluate the potential of cortico-cerebellar network properties derived from neuroimaging in a group of chronic stroke patients to explain inter-subject variability in responsiveness to transcranial direct current stimulation (tDCS) targeting the cortico-spinal and cortico-cerebellar network.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
* patients after first-ever clinical ischemic stroke in the early (\>3 month) or later chronic (\>6 months) stage of recovery
* persistent motor deficit of the upper extremity
* stroke location: supratentorial
* age \> 18 years
* written informed consent obtained
Exclusion Criteria:
* contraindication against MRI \& tDCS
* known epilepsy, previous epileptic seizure
* electric implants such as brain stimulator
* medical history suggesting more than one previous stroke
* severe polyneuropathy and peripheral ischemic vascular diseases; only if they critically influence sensorimotor function of the upper limb
* any active drug and alcohol abuse
* any active and severe psychiatric disease (such as psychosis)
* severe cognitive deficits (mini mental state examination, MMSE ≤ 23)
* uncontrolled other medical problems (cardiovascular diseases, instable arrhythmia, arthritis)
Primary outcome measure(s)
Relationship between properties of the cortico-spinal and cortico-cerebellar motor network and change in FMA from baseline in the verum and sham conditions until last training day (Day 7) — Baseline - Day 7 Statistics will be conducted to relate single-patient data of structural and functional network properties to treatment gains in the FMA during active and sham stimulations. Treatment gains will be defined as change from baseline until last training day (Day 7). Statistics will be adjusted for baseline values.
Relationship between properties of the cortico-spinal and cortico-cerebellar motor network and change in FMA from baseline in the verum and sham conditions until 1 week after last training day (Day 14) — Baseline - Day 14 Statistics will be conducted to relate single-patient data of structural and functional network properties to treatment gains in the FMA during active and sham stimulations. Treatment gains will be defined as change from baseline until 1 week after last training day (Day 14). Statistics will be adjusted for baseline values.
Relationship between properties of the cortico-spinal and cortico-cerebellar motor network and change in NIHSS from baseline in the verum and sham conditions until last training day (Day 7) — Baseline - Day 7 Statistics will be conducted to relate single-patient data of structural and functional network properties to treatment gains in the NIHSS during active and sham stimulations. Treatment gains will be defined as change from baseline until last training day (Day 7). Statistics will be adjusted for baseline values.
Relationship between properties of the cortico-spinal and cortico-cerebellar motor network and change in NIHSS from baseline in the verum and sham conditions until 1 week after last training day (Day 14) — Baseline - Day 14 Statistics will be conducted to relate single-patient data of structural and functional network properties to treatment gains in the NIHSS during active and sham stimulations. Treatment gains will be defined as change from baseline until 1 week after last training day (Day 14). Statistics will be adjusted for baseline values.
Relationship between properties of the cortico-spinal and cortico-cerebellar motor network and change in WMFT from baseline in the verum and sham conditions until last training day (Day 7) — Baseline - Day 7 Statistics will be conducted to relate single-patient data of structural and functional network properties to treatment gains in WMFT during active and sham stimulations. Treatment gains will be defined as change from baseline until last training day (Day 7). Statistics will be adjusted for baseline values.
Relationship between properties of the cortico-spinal and cortico-cerebellar motor network and change in WMFT from baseline in the verum and sham conditions until 1 week after last training day (Day 14) — Baseline - Day 14 Statistics will be conducted to relate single-patient data of structural and functional network properties to treatment gains in WMFT during active and sham stimulations. Treatment gains will be defined as change from baseline until 1 week after last training day (Day 14). Statistics will be adjusted for baseline values.
Relationship between properties of the cortico-spinal and cortico-cerebellar motor network and change in JTT from baseline in the verum and sham conditions until last training day (Day 7) — Baseline - Day 7 Statistics will be conducted to relate single-patient data of structural and functional network properties to treatment gains in JTT during active and sham stimulations. Treatment gains will be defined as change from baseline until last training day (Day 7). Statistics will be adjusted for baseline values.
Relationship between properties of the cortico-spinal and cortico-cerebellar motor network and change in JTT from baseline in the verum and sham conditions until 1 week after last training day (Day 14) — Baseline - Day 14 Statistics will be conducted to relate single-patient data of structural and functional network properties to treatment gains in JTT during active and sham stimulations. Treatment gains will be defined as change from baseline until 1 week after last training day (Day 14). Statistics will be adjusted for baseline values.
Relationship between properties of the cortico-spinal and cortico-cerebellar motor network and change in NHP from baseline in the verum and sham conditions until last training day (Day 7) — Baseline - Day 7 Statistics will be conducted to relate single-patient data of structural and functional network properties to treatment gains in the NHP during active and sham stimulations. Treatment gains will be defined as change from baseline until last training day (Day 7). Statistics will be adjusted for baseline values.
Relationship between properties of the cortico-spinal and cortico-cerebellar motor network and change in NHP from baseline in the verum and sham conditions until 1 week after last training day (Day 14) — Baseline - Day 14 Statistics will be conducted to relate single-patient data of structural and functional network properties to treatment gains in the NHP during active and sham stimulations. Treatment gains will be defined as change from baseline until 1 week after last training day (Day 14). Statistics will be adjusted for baseline values.
Trial sites (1)
Facility
City
Region
Status
University Medical Center Hamburg-Eppendorf, Dept. of Neurology
Hamburg
Free and Hanseatic City of Hamburg
Recruiting
More Universitätsklinikum Hamburg-Eppendorf trials in Germany
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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