A neurorehabilitation therapy based on a brain machine interface (BMI) for the motor function restoration of the upper limb in chronic stroke patients.

Not Applicable

Suspended

• Conditions: Chronic stroke patients with severely paralyzed upper-limb; Nervous System Diseases; Chronic stroke

• Registration Number: ISRCTN10150672
• Lead Sponsor: Instituto de Investigación Sanitaria Biodonostia (Spain)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-05-07
• Last Update Posted: 12 December 2023
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: Suspended
• Sex: All
• Target Recruitment: 6

Inclusion Criteria

Assessment of physical and psychological function and impairment:
1. Wolf-Motor test
2. Goal Attainment Scale (GAS)
3. Motor Activity Log
4. KVIQ-20
5. Modified Ashworth scales (spasticity)
6. Beck Depression Inventory (BDI)
7. Hamilton Depression Rating Scale (HDRS)
8. Berlin Social Support Scale (BSSS)
9. The Schedule for the Evaluation of the Individual Quality of Life-Direct Weighting (SEIQoL-DW) (quality of life)
10. Placebo Questionnaire

Patients will be selected according to strict inclusion criteria, including but not limited to their level of impairment, physiology of the stroke lesion, psychological and cognitive characteristics.

All participants should fulfill the following criteria:
1. Paralysis of one hand with no residual active finger extension
2. Considerable motor impairment in the upper-limb, with MRC (Medical Research Council) below 2 out of 5 (5 = muscle contraction against full resistance, normal; 4 = reduced strength, but contraction can still move joint against resistance; 3 = strength further reduced such that joint can be moved only against gravity with examiner's resistance completely removed; 2 = muscle can only move if resistance of gravity is removed; 1 = only a trace or flicker of movement is seen or felt, or muscle twitching/spasms (fasciculations) are observed; 0 = no movement).
3. Ischemic or hemorrhagic stroke with subcortical damage and, if possible, intact motor cortex.
4. Time since stroke of at least 9 months (chronic stage)
5. Age 18 to 70
6. No psychiatric or neurological condition other than stroke
7. No cerebellar lesion or bilateral motor deficit
8. No pregnancy
9. No claustrophobia
10. No epilepsy or medication for epilepsy during the last 6 months
11. Eligibility to undergo magnetic resonance imaging (MRI)
12. Ability to understand and follow instructions

Exclusion Criteria

1. Drug and/or alcohol abuse
2. Psychiatric disorder (including post-stroke depression)
3. Cerebellar damage
4. Bilateral motor deficit
5. Uncontrolled health problems (coronary heart disease, severe heart failure in stage III-IV according to NYHA, severe cardiac arrhythmia, severe edema, severe arthritis, malignant tumor, chronic renal failure)
6. Cognitive impairment (Mini Mental State below 23/30 points). Patients with cognitive or language difficulties that will prevent them giving informed consent and/or follow instructions
7. Pregnancy
8. Drug-resistant epilepsy
9. Pacemakers, metallic implants (ferromagnetic) or claustrophobia, contraindications to undergo magnetic resonance imaging (MRI)

Study & Design

• Study Type: Interventional
• Study Design: Not specified