Theta-Burst-Stimulation in Recurrent Stroke Recovery

NCT ID: NCT03337867

Last Updated: 2019-11-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-11

Study Completion Date

2021-11-01

Brief Summary

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The present study aims at investigating the effects of intermittent theta-burst stimulation (iTBS) for motor recovery in recurrent stroke patients. Therefore a daily intervention of repetitive transcranial magnetic stimulation over 8 days combined with subsequent physiotherapy is compared to a control condition, sham stimulation combined with subsequent physiotherapy. Motor function, degree of disability and quality of life are examined in order to evaluate the effects of iTBS in the rehabilitation of recurrent stroke patients in the first weeks and after three months.

Detailed Description

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To date, the majority of neuromodulation approaches aiming at improving motor recovery after stroke are limited to patients with first-ever ischemic stroke. Therefore, rehabilitation of recurrent stroke mainly includes physiotherapy and occupational therapy. Yet, particular these patients retain movement impairment relevant for activities of daily living.

By using repetitive transcranial magnetic stimulation (rTMS), it is possible to promote recovery of connectivity between brain regions, particularly after stroke and thereby improve motor performance. Previous data indicate that intermittent theta-burst stimulation (iTBS), a protocol of neuromodulation, enhances the effects of subsequent motor training in early rehabilitation after stroke.

The current study aims at investigating whether daily repetitive transcranial magnetic stimulation over 8 days combined with subsequent physiotherapy leads to better motor recovery in recurrent stroke, compared to control condition, physiotherapy after sham stimulation. Motor function, degree of disability and quality of life are examined in order to evaluate the effects of iTBS in the rehabilitation of recurrent stroke patients in the first weeks and after three months.

Conditions

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Stroke Neurorehabilitation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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Real-iTBS

Group Type ACTIVE_COMPARATOR

Magstim Super Rapid2 System

Intervention Type DEVICE

Intermittent theta-burst-stimulation (iTBS) protocol

Sham-iTBS

Group Type SHAM_COMPARATOR

Magstim Super Rapid2 System

Intervention Type DEVICE

Sham stimulation

Interventions

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Magstim Super Rapid2 System

Intermittent theta-burst-stimulation (iTBS) protocol

Intervention Type DEVICE

Magstim Super Rapid2 System

Sham stimulation

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* written consent
* age: 40-90 years
* recurrent stroke
* hemiparesis with impaired hand motor function

Exclusion Criteria

* Subjects who are legally detained in an official institute (ยง20 MPG)
* 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
* Frequent 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

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University Hospital of Cologne

OTHER

Sponsor Role lead

Responsible Party

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Christian Grefkes

Principal Investigator, Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Christian Grefkes, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital Cologne

Locations

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Christian Grefkles

Cologne, , Germany

Site Status

Countries

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Germany

Other Identifiers

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U1111-1204-6783

Identifier Type: -

Identifier Source: org_study_id

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