Back to results

Theta-Burst-Stimulation in Early Rehabilitation of Stroke (TheSiReS)

Primary Purpose

Stroke

Status

Completed

Phase

Phase 2

Locations

Germany

Study Type

Interventional

Intervention

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

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

About this trial

This is an interventional treatment trial for Stroke

Eligibility Criteria

40 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Klinik und Poliklinik für Neurologie, Universitätsklinikum Köln

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

Real-rTMS

Sham-rTMS

Arm Description

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

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

Outcomes

Primary Outcome Measures

Relative grip force

grip force as measured with vigorimeter

Secondary Outcome Measures

Relative grip force

grip force as measured with vigorimeter

Motor function

Action Research Arm Test, ARAT

Motor function

Fugl-Meyer Motor Scale of the upper extremity, FM

Stroke severity

National Instituts of Health Stroke Scale, NIHSS

Degree of disability

modified Rankin Scale, mRS

Motorcortex excitability

Motor evoked potential induced by stimulation of the affected motor cortex, MEP

Motorcortex excitability

Resting motor threshold as measured by stimulation of the affected motor cortex, RMT

Quality of life

EuroQol 5D questionnaire, EQ-5D

Activities of daily living at admission and discharge in external rehabilitation facility

Barthel-Index (BI) scores as documented by external rehabilitation facility

Days of rehabilitation after intervention phase

Days of rehabilitation after intervention phase as documented by external rehabilitation facility

Full Information

NCT ID

NCT02910024

First Posted

September 8, 2016

Last Updated

September 19, 2022

Sponsor

University of Cologne

1. Study Identification

Unique Protocol Identification Number

NCT02910024

Brief Title

Theta-Burst-Stimulation in Early Rehabilitation of Stroke

Acronym

TheSiReS

Official Title

Theta-Burst-Stimulation in Der frühen Rehabilitation Von Schlaganfallpatienten

Study Type

Interventional

2. Study Status

Record Verification Date

September 2022

Overall Recruitment Status

Completed

Study Start Date

April 2016 (Actual)

Primary Completion Date

September 15, 2022 (Actual)

Study Completion Date

September 15, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Cologne

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Stroke

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2, Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

150 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Real-rTMS

Arm Type

Active Comparator

Arm Description

Arm Title

Sham-rTMS

Arm Type

Sham Comparator

Arm Description

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

Intervention Type

Device

Intervention Name(s)

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

Intervention Description

iTBS applied over ipsilesional M1

Intervention Type

Device

Intervention Name(s)

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

Intervention Description

iTBS applied with tilted coil over parieto-occipital vertex

Primary Outcome Measure Information:

Title

Relative grip force

Description

grip force as measured with vigorimeter

Time Frame

3 months after enrollment

Secondary Outcome Measure Information:

Title

Relative grip force

Description

grip force as measured with vigorimeter

Time Frame