NCT03337867

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P50-P75 for phase_2 stroke

Timeline
Completed

Started Jan 2018

Typical duration for phase_2 stroke

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 3, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 9, 2017

Completed
2 months until next milestone

Study Start

First participant enrolled

January 11, 2018

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2021

Completed
Last Updated

November 27, 2019

Status Verified

November 1, 2019

Enrollment Period

3.8 years

First QC Date

November 3, 2017

Last Update Submit

November 25, 2019

Conditions

StrokeNeurorehabilitation

Keywords

Recurrent strokeStrokeTranscranial Magnetic StimulationTheta-Burst-Stimulation

Outcome Measures

Primary Outcomes (1)

  • Relative grip force

    grip force as measured with vigorimeter

    3 months after enrollment

Secondary Outcomes (12)

  • Relative grip force

    After 8 days of intervention, and 3 months of enrollment

  • Motor function

    After 8 days of intervention, and 3 months of enrollment

  • Motor function

    After 8 days of intervention, and 3 months of enrollment

  • Stroke severity

    After 8 days of intervention, and 3 months of enrollment

  • Degree of disability

    After 8 days of intervention, and 3 months of enrollment

  • +7 more secondary outcomes

Study Arms (2)

Real-iTBS

ACTIVE COMPARATOR
Device: Magstim Super Rapid2 System

Sham-iTBS

SHAM COMPARATOR
Device: Magstim Super Rapid2 System

Interventions

Magstim Super Rapid2 SystemDEVICE

Intermittent theta-burst-stimulation (iTBS) protocol

Real-iTBS

Eligibility Criteria

Age40 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Subjects who are legally detained in an official institute (§20 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Christian Grefkles

Cologne, 50937, Germany

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Christian Grefkes, MD

    University Hospital Cologne

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator, Professor

Study Record Dates

First Submitted

November 3, 2017

First Posted

November 9, 2017

Study Start

January 11, 2018

Primary Completion

November 1, 2021

Study Completion

November 1, 2021

Last Updated

November 27, 2019

Record last verified: 2019-11

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)