NCT03947645

Brief Summary

Chronic stroke patients (\> 6 months) with severe motor impairment of the upper extremity will be enrolled in this single-centre, randomized controlled clinical trial (RCT). All patients will take part in two blocks of high-intense motor training with concurrent neuromuscular stimulation of the paretic upper extremity. In a randomized, cross-over block design, patients will receive transcranial stimulation of either the ipsi- or contralesional hemisphere.

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
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2019

Longer than P75 for not_applicable

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

May 2, 2019

Completed
Same day until next milestone

Study Start

First participant enrolled

May 2, 2019

Completed
11 days until next milestone

First Posted

Study publicly available on registry

May 13, 2019

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2022

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed
Last Updated

September 29, 2021

Status Verified

September 1, 2021

Enrollment Period

2.8 years

First QC Date

May 2, 2019

Last Update Submit

September 28, 2021

Conditions

Chronic Stroke

Outcome Measures

Primary Outcomes (1)

  • Fugl-Meyer Assessment (Upper Extremity)

    change from baseline to both directly after intervention and 3 months after

Secondary Outcomes (17)

  • Action Research Arm Test (ARAT)

    change from baseline to both directly after intervention and 3 months after

  • Arm-A

    change from baseline to both directly after intervention and 3 months after

  • Modified Ashworth Scale (MAS)

    change from baseline to both directly after intervention and 3 months after

  • Fugl-Meyer Assessment (Lower Extremity)

    change from baseline to both directly after intervention and 3 months after

  • 10m walking test

    change from baseline to both directly after intervention and 3 months after

  • +12 more secondary outcomes

Other Outcomes (4)

  • Elektroencephalography in resting and active states

    change from baseline to both directly after intervention and 3 months after

  • Input-Output curves and motor maps with transcranial magnetic stimulation

    change from baseline to both directly after intervention and 3 months after

  • Task-related and evoked electromyography

    change from baseline to both directly after intervention and 3 months after

  • +1 more other outcomes

Study Arms (2)

Ipsilesional stimulation

EXPERIMENTAL

Ipsilesional stimulation

Device: Ipsilesional stimulation

Contralesional stimulation

EXPERIMENTAL

Contralesional stimulation

Device: Contralesional stimulation

Interventions

Ipsilesional stimulationDEVICE

Device: ipsilesional transcranial stimulation, neuromuscular Stimulation over target muscle

Ipsilesional stimulation
Contralesional stimulationDEVICE

Device: contralesional transcranial stimulation, neuromuscular stimulation over target muscle

Contralesional stimulation

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Written informed consent
  • Chronic stage of stroke (\> 6 months)
  • No active finger extension/hand opening of the paretic side

You may not qualify if:

  • Pregnancy
  • Epilepsy
  • Metal implants
  • Pacemaker

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Tübingen

Tübingen, Baden-Wurttemberg, 72076, Germany

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 2, 2019

First Posted

May 13, 2019

Study Start

May 2, 2019

Primary Completion

February 1, 2022

Study Completion

December 1, 2022

Last Updated

September 29, 2021

Record last verified: 2021-09

Locations

DE(1)