Theta-Burst-Stimulation in Early Rehabilitation of Stroke

Stroke Clinical Trial

— TheSiReS  

Official title:

Theta-Burst-Stimulation in Der frühen Rehabilitation Von Schlaganfallpatienten

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02910024
• Other study ID #: Uni-Koeln-1778
• Secondary ID: U1111-1172-6026C
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: April 2016
• Est. completion date: September 15, 2022

Study information

• Verified date: September 2022
• Source: University of Cologne
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

To date, rehabilitation of stroke with hemiparesis mainly includes physiotherapy and occupational therapy. Yet, the majority of patients retain movement impairment relevant for activities of daily living. One explanation for this deficit is the insufficient recovery of connectivity between brain regions after stroke. It is possible to modulate this process by repetitive transcranial magnetic stimulation (rTMS) using the protocol of intermittent theta-burst stimulation (iTBS). Previous data indicate that modulation of the motor cortex with iTBS enhances the effects of subsequent motor training. The present study aims at investigating whether daily repetitive transcranial magnetic stimulation over 8 days combined with subsequent physiotherapy leads to better motor recovery, compared with physiotherapy after sham stimulation. In the first weeks and after three months, motor function, degree of disability and quality of life are examined in order to evaluate the effects of iTBS in the rehabilitation of stroke patients.

Amendment (approved by the Ethics-Committee of the Medical Faculty of the University of Cologne, 20/12/2016): Specification of exclusion criteria.

Amendment (approved by the Ethics-Committee of the Medical Faculty of the University of Cologne, 15/11/2018): Change of inclusion and exclusion criteria.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: September 15, 2022
• Est. primary completion date: September 15, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 90 Years

Eligibility

Inclusion Criteria:

• written consent

• age: 40-90 years

• ischemic stroke

• hemiparesis with impaired hand motor function

Exclusion Criteria:

• 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)

• Known brain lesion (surgical, traumatic)

• Evidence for enhanced cerebral pressure

• Severe cardial dysfunction

• life expectancy < 12 months

• NIHSS Score > 20

• Blood glucose imbalances resistant to treatment (<50 mg/dl or >300 mg/dl)

• Elevated blood pressure resistant to treatment (RR > 185/110mmHg)

• Systemic Thrombolysis using r-tPA or thrombectomy within the last 24 hours before enrollment in study

• Medication with benzodiazepines, high-potency antipsychotics or tricyclic antidepressants before hospitalization or long-term during hospitalization

Related Conditions & MeSH terms

• Stroke

Intervention

Device:
• Magstim Super Rapid2 System, intermittent theta-burst-stimulation (iTBS) protocol
iTBS applied over ipsilesional M1
• Magstim Super Rapid2 System, sham-stimulation (in iTBS)
iTBS applied with tilted coil over parieto-occipital vertex

Locations

Country	Name	City	State
Germany	Klinik und Poliklinik für Neurologie, Universitätsklinikum Köln	Cologne	North Rhine-Westphalia

Sponsors (1)

Lead Sponsor	Collaborator
University of Cologne

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Relative grip force	grip force as measured with vigorimeter	3 months after enrollment
Secondary	Relative grip force	grip force as measured with vigorimeter	after 8 days of intervention, and 3 months after enrollment
Secondary	Motor function	Action Research Arm Test, ARAT	after 8 days of intervention, and 3 months after enrollment
Secondary	Motor function	Fugl-Meyer Motor Scale of the upper extremity, FM	after 8 days of intervention, and 3 months after enrollment
Secondary	Stroke severity	National Instituts of Health Stroke Scale, NIHSS	after 8 days of intervention, and 3 months after enrollment
Secondary	Degree of disability	modified Rankin Scale, mRS	after 8 days of intervention, and 3 months after enrollment
Secondary	Motorcortex excitability	Motor evoked potential induced by stimulation of the affected motor cortex, MEP	after 8 days of intervention, and 3 months after enrollment
Secondary	Motorcortex excitability	Resting motor threshold as measured by stimulation of the affected motor cortex, RMT	after 8 days of intervention, and 3 months after enrollment
Secondary	Quality of life	EuroQol 5D questionnaire, EQ-5D	after 8 days of intervention, and 3 months after enrollment
Secondary	Activities of daily living at admission and discharge in external rehabilitation facility	Barthel-Index (BI) scores as documented by external rehabilitation facility	3 months after enrollment
Secondary	Days of rehabilitation after intervention phase	Days of rehabilitation after intervention phase as documented by external rehabilitation facility	3 months after enrollment