Theta-Burst-Stimulation in Early Rehabilitation of Stroke
TheSiReS
Theta-Burst-Stimulation in Der frühen Rehabilitation Von Schlaganfallpatienten
4 other identifiers
interventional
150
1 country
1
Brief Summary
The present prospective, randomized, controlled, double-blinded trial investigates the effects of intermittent theta-burst stimulation (iTBS) during the early rehabilitation after stroke. Patients with hemipresis will receive either sham or real iTBS over their affected hemispheres before occupational therapy for 8 days. Motor recovery is assessed one day after the intervention phase and three months after enrollment.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 stroke
Started Apr 2016
Longer than P75 for phase_2 stroke
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2016
CompletedFirst Submitted
Initial submission to the registry
September 8, 2016
CompletedFirst Posted
Study publicly available on registry
September 21, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 15, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
September 15, 2022
CompletedSeptember 21, 2022
September 1, 2022
6.5 years
September 8, 2016
September 19, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Relative grip force
grip force as measured with vigorimeter
3 months after enrollment
Secondary Outcomes (10)
Relative grip force
after 8 days of intervention, and 3 months after enrollment
Motor function
after 8 days of intervention, and 3 months after enrollment
Motor function
after 8 days of intervention, and 3 months after enrollment
Stroke severity
after 8 days of intervention, and 3 months after enrollment
Degree of disability
after 8 days of intervention, and 3 months after enrollment
- +5 more secondary outcomes
Study Arms (2)
Real-rTMS
ACTIVE COMPARATORRepetitive transcranial magnetic stimulation (rTMS) of the primary motor cortex in the lesioned hemisphere using the intermittent theta-burst-stimulation protocol (iTBS; application of 3 pulses with a frequency of 50 Hz, in a theta-rhythm of 5 Hz for 2 seconds, repeated every 10 seconds, duration of one session: about 3,5 minutes) before physiotherapy for 8 days
Sham-rTMS
SHAM COMPARATORRepetitive transcranial magnetic stimulation (rTMS) in sham position (tilted coil over parieto-occipital vertex) before physiotherapy for 8 days
Interventions
iTBS applied over ipsilesional M1
iTBS applied with tilted coil over parieto-occipital vertex
Eligibility Criteria
You may qualify if:
- written consent
- age: 40-90 years
- ischemic stroke
- hemiparesis with impaired hand motor function
You may not qualify if:
- Subjects who are legally detained in an official institute (§20 MPG)
- Participation in clinical trial within the last 12 weeks
- Electronic implants or ferromagnetic Implants located in the head, neck or thorax (e.g. clips, intracranial shunt, artificial heart valve, pacemaker)
- Medication pump (e.g. insulin pump)
- Metal splinters in eye or head
- Pregnancy / breastfeeding
- Severe Neurodegenerative disease
- Severe Neuroinflammatory disease
- History of seizures / epilepsy
- Physical addiction to alcohol, medication, or drugs (excluded: nicotine)
- Insufficient compliance
- Present or past malignant tumor involving the central nervous system
- Severe Psychiatric disease
- Clinically manifest bilateral hemiparesis or infarcts in the primary motor cortex or along the tractus corticospinalis in the hemisphere ipsilateral to the hemiparesis
- Pre-existing cerebral infarctions with hemiparesis or pre-existing cerebral infarctions in the primary motor cortex or along the tractus corticospinalis, excluding microangiopathic changes (e.g. clinically asymptomatic lacunae \<1cm)
- +9 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Klinik und Poliklinik für Neurologie, Universitätsklinikum Köln
Cologne, North Rhine-Westphalia, 50924, Germany
Related Publications (1)
Hensel L, Grefkes C, Tscherpel C, Ringmaier C, Kraus D, Hamacher S, Volz LJ, Fink GR. Intermittent theta burst stimulation applied during early rehabilitation after stroke: study protocol for a randomised controlled trial. BMJ Open. 2019 Dec 30;9(12):e034088. doi: 10.1136/bmjopen-2019-034088.
PMID: 31892668DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Gereon R Fink, Univ.-Prof. Dr.
University of Cologne
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Prof. Dr. med.
Study Record Dates
First Submitted
September 8, 2016
First Posted
September 21, 2016
Study Start
April 1, 2016
Primary Completion
September 15, 2022
Study Completion
September 15, 2022
Last Updated
September 21, 2022
Record last verified: 2022-09
Data Sharing
- IPD Sharing
- Will not share