Theta-Burst-Stimulation in Early Rehabilitation of Stroke

NCT ID: NCT02910024

Last Updated: 2022-09-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-04-30
• Study Completion Date: 2022-09-15

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.

Detailed 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.

Conditions

Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Real-rTMS

Repetitive 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

Group Type: ACTIVE_COMPARATOR

Magstim Super Rapid2 System, intermittent theta-burst-stimulation (iTBS) protocol

Intervention Type: DEVICE

iTBS applied over ipsilesional M1

Sham-rTMS

Repetitive transcranial magnetic stimulation (rTMS) in sham position (tilted coil over parieto-occipital vertex) before physiotherapy for 8 days

Group Type: SHAM_COMPARATOR

Magstim Super Rapid2 System, sham-stimulation (in iTBS)

Intervention Type: DEVICE

iTBS applied with tilted coil over parieto-occipital vertex

Interventions

Magstim Super Rapid2 System, intermittent theta-burst-stimulation (iTBS) protocol

iTBS applied over ipsilesional M1

Intervention Type: DEVICE

Magstim Super Rapid2 System, sham-stimulation (in iTBS)

iTBS applied with tilted coil over parieto-occipital vertex

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Cologne

OTHER

Sponsor Role: lead

Responsible Party

Gereon R. Fink

Prof. Dr. med.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Gereon R Fink, Univ.-Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

University of Cologne

Locations

Klinik und Poliklinik für Neurologie, Universitätsklinikum Köln

Cologne, North Rhine-Westphalia, Germany

Countries

Germany

References

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.

Reference Type: DERIVED

PMID: 31892668 (View on PubMed)

Other Identifiers

U1111-1172-6026

Identifier Type: OTHER

Identifier Source: secondary_id

CIV-15-09-013868

Identifier Type: OTHER

Identifier Source: secondary_id

DRKS00008963

Identifier Type: REGISTRY

Identifier Source: secondary_id

Uni-Koeln-1778

Identifier Type: -

Identifier Source: org_study_id