Intensive Neurorehabilitation and Stimulation in Chronic Stroke Patients

• ClinicalTrials.gov Identifier: NCT03947645
• Recruitment Status: Active, not recruiting
• First Posted: May 13, 2019
• Last Update Posted: September 29, 2021
• Sponsor: University Hospital Tuebingen
• Information provided by (Responsible Party): University Hospital Tuebingen

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Chronic Stroke	Device: Ipsilesional stimulation; Device: Contralesional stimulation	Not Applicable

Detailed 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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 20 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Intensive Neurorehabilitation and Stimulation in Chronic Stroke Patients With Severe Motor Impairment of the Upper Extremity
• Actual Study Start Date: May 2, 2019
• Estimated Primary Completion Date: February 1, 2022
• Estimated Study Completion Date: December 1, 2022

Arms and Interventions

Arm	Intervention/treatment
Experimental: Ipsilesional stimulation; Ipsilesional stimulation	Device: Ipsilesional stimulation; Device: ipsilesional transcranial stimulation, neuromuscular Stimulation over target muscle
Experimental: Contralesional stimulation; Contralesional stimulation	Device: Contralesional stimulation; Device: contralesional transcranial stimulation, neuromuscular stimulation over target muscle

Outcome Measures

Primary Outcome Measures :

1. Fugl-Meyer Assessment (Upper Extremity) [ Time Frame: change from baseline to both directly after intervention and 3 months after ]

Secondary Outcome Measures :

1. Action Research Arm Test (ARAT) [ Time Frame: change from baseline to both directly after intervention and 3 months after ]
   Motor Impairment of the upper extremity. Several objects in different sizes and weights should be moved by patients.
2. Arm-A [ Time Frame: change from baseline to both directly after intervention and 3 months after ]
   Questionnaire on capability to care for the paretic arm in different situations of daily living. Scale ranges from 0 (no problems) to 4 (impossible to do).
3. Modified Ashworth Scale (MAS) [ Time Frame: change from baseline to both directly after intervention and 3 months after ]
   Spasticity in different body parts. Scale ranges from 0 (no spasticity) to 4 (rigid).
4. Fugl-Meyer Assessment (Lower Extremity) [ Time Frame: change from baseline to both directly after intervention and 3 months after ]
   Assessment of motor impairment of the lower extremity.
5. 10m walking test [ Time Frame: change from baseline to both directly after intervention and 3 months after ]
   Assessment of motor impairment of the lower extremity.
6. National Institute of Stroke Scale (NIHSS) [ Time Frame: baseline ]
   Assessment of severity of stroke and neurological deficits. Scale ranges from 0 (normal) to 2, 3 or 4 (depending on the item).
7. Modified Rankin Scale (mRS) [ Time Frame: change from baseline to both directly after intervention and 3 months after ]
   Degree of disability after stroke on a scale from 0 (no symptoms) to 6 (dead).
8. EQ-5D [ Time Frame: change from baseline to both directly after intervention and 3 months after ]
   Questionnaire on subjective health status. Patients should rate their health status for that day in different tasks of daily living on a scale from no problems, minor problems, moderate problems, big problems to not possible at all.
9. CAHAI-13 [ Time Frame: change from baseline to both directly after intervention and 3 months after ]
   Test on activities of daily living. Patients should perform several tasks and are scored from 1 (total assist) to 7 (complete independence).
10. Stroke Impact Scale [ Time Frame: change from baseline to both directly after intervention and 3 months after ]
    Questionnaire on subjective impact of stroke on daily living and health status. Scale ranges from 1 (most negative answer) to 5 (most positive answer).
11. Barthel Index [ Time Frame: change from baseline to both directly after intervention and 3 months after ]
    Questionnaire on extent to which patients can perform activities of daily living on their own. Patients can reach 0 (cannot perform any task) to a maximum of 100 points (can do everything on their own).
12. Hospital Anxiety and Depression Scale [ Time Frame: change from baseline to both directly after intervention and 3 months after ]
    Questionnaire on anxiety and depression. Scale ranges from 0 (most positive answer) to 3 (most negative answer).
13. Neurological Fatigue Index [ Time Frame: change from baseline to both directly after intervention and 3 months after ]
    Questionnaire on fatigue in the last two weeks. Scale ranges from no agreement at all, no agreement, agreement to some extent to full agreement.
14. NEO-Fünf-Faktoren Inventar [ Time Frame: baseline ]
    Personality questionnaire with 60 statements that patients should rate ranging from strong disagreement, disagreement, neutral, agreement to strong agreement.
15. Situational Motivation Scale [ Time Frame: change from baseline to both directly after intervention and 3 months after ]
    Questionnaire on motivation to participate in training. Scale ranges from 0 (not correct at all) to 6 (strongly agree).
16. Berlin Social Support Scale [ Time Frame: change from baseline to both directly after intervention and 3 months after ]
    Questionnaire to evaluate social support. Patients should rate different questions regarding their most important attachment figure ranging from no agreement at all, no agreement, agreement to some extent to full agreement.
17. Credibility/Expectancy Questionnaire [ Time Frame: change from baseline to both directly after intervention and 3 months after ]
    Questionnaire to evaluate expectancies on current program. Scale rangs from 0 (most negative) to 9 (most positive).

Other Outcome Measures:

1. Elektroencephalography in resting and active states [ Time Frame: change from baseline to both directly after intervention and 3 months after ]
2. Input-Output curves and motor maps with transcranial magnetic stimulation [ Time Frame: change from baseline to both directly after intervention and 3 months after ]
3. Task-related and evoked electromyography [ Time Frame: change from baseline to both directly after intervention and 3 months after ]
4. Camera and marker-based motion capturing [ Time Frame: change from baseline to both directly after intervention and 3 months after ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 80 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Locations

Germany

University Hospital Tübingen

Tübingen, Baden-Württemberg, Germany, 72076

Sponsors and Collaborators

University Hospital Tuebingen

More Information

• Responsible Party: University Hospital Tuebingen
• ClinicalTrials.gov Identifier: NCT03947645
• Other Study ID Numbers: In-Tens
• First Posted: May 13, 2019
• Last Update Posted: September 29, 2021
• Last Verified: September 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases