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Intensive Neurorehabilitation and Stimulation in Chronic Stroke Patients

U

University Hospital Tuebingen

Status

Unknown

Conditions

Chronic Stroke

Treatments

Device: Ipsilesional stimulation
Device: Contralesional stimulation

Study type

Interventional

Funder types

Other

Identifiers

NCT03947645
In-Tens

Details and patient eligibility

About

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.

Full description

Chronic stroke patients (> 6 months) with severe motor impairment of the upper extremity and non-proportional recovery 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.

The primary outcome measure is the Fugl-Meyer Assessment for upper extremity (FM-UE), acquired at baseline, after the intervention period, and at 3 months follow-up. Secondary outcome measures consist of further clinical parameters and biomarkers of corticospinal connectivity.

Enrollment

20 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

  • Pregnancy
  • Epilepsy
  • Metal implants
  • Pacemaker

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Quadruple Blind

20 participants in 2 patient groups

Ipsilesional stimulation
Experimental group
Description:
Ipsilesional stimulation
Treatment:
Device: Ipsilesional stimulation
Contralesional stimulation
Experimental group
Description:
Contralesional stimulation
Treatment:
Device: Contralesional stimulation

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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