Brain-computer interface and neuromuscular stimulation for rehabilitation following acute stroke

• Register: German Clinical Trials Register
• Last refreshed on: 21 May 2024
• Main ID: DRKS00007832
• Date of registration: 24/02/2015
• Prospective Registration: No
• Primary sponsor: Universitätsklinik für Neurologie
• Public title: Brain-computer interface and neuromuscular stimulation for rehabilitation following acute stroke
• Scientific title: Brain-computer interface and neuromuscular stimulation for rehabilitation following acute stroke - BCI-NMES-CVA
• Date of first enrolment: 23/02/2015
• Target sample size: 40
• Recruitment status: Recruiting
• URL: http://drks.de/search/en/trial/DRKS00007832
• Study type: interventional
• Study design: Allocation: Randomized controlled study; Masking: Blinded (masking used); Control: active; Assignment: parallel; Study design purpose: treatment
• Phase: N/A

Countries of recruitment

Germany, Italy, Switzerland

Contacts

• Name: Catherine Sweeney-Reed
• Affiliation: Unversitätsklinik für Neurologie

• Name: Catherine Sweeney-Reed
• Affiliation: Universitätsklinik für Neurologie

Key inclusion & exclusion criteria

Inclusion criteria: - First stroke (thrombotic or haemorrhagic), diagnosed with CT or MRI, lasting more than 24 hours to 4 weeks
- Reduced or absent power of the affected extremity (arm/hand)
Exclusion criteria: - sever aphasia
- Medical Research Council Power Test: >= 3
- cognitive impairment leading to inability to perform the tasks: Montreal Cognitive Assessment (> 25)
- severe depression
- medically unstable (postural hypotension, sepsis, epilepsy, severe renal failure, hemispatial neglect, severe visual impairment, fixed joint contractures, skin condition which could be worsened by electrode placement)
- certain medications (L-dopa, amantadine. Antidepressive medication is permissible.)
- history of epilepsy
- Fatigue Severity Scale: > 36/63
- Pain Scale: > 5/10

Age minimum: 18 Years
Age maximum: None
Gender: All

Health Condition(s) or Problem(s) studied

Cerebral infarction

I61
I63

Intracerebral haemorrhage

Intervention(s)

Group 1: Test group (20 participants): the arm musculature will be stimulated at the timepoint at which the patient attempts to move, determined from the EEG.
Group 2: Control group (20 participants): the electrodes will also be placed, but the stimulation timing will be random.

Primary Outcome(s)

Improvement of mobility, to enable performance of daily tasks. To be evaluated and quantified using the Fugl-Mayr Assessment: motor arm.

The test will be carried out before the therapy, at the end of each week of therapy, and 6 months after the therapie.

Secondary Outcome(s)

The following tests will be carried out before the therapy, after 3 and 5 weeks, and 6 months after the therapy:
- Medical Research Council Power Test
- Rivermead Test
- Barthel Index
- National Institute of Health Stroke Scale (motor: Arm)
- European Stroke Scale
- Modified Ashworth Scale (spasticity)
- Sensory deficits (Since feedback is visual as well as sensory, these patients will be included. Baseline 2-point discrimination and proprioceptive tests will be performed.)
- Standard clinical evaluation of the cranial and peripheral nerves, gait, Romberg test
- Neuropsychological profile (with Montreal Cognitive Assessment)
- Goal attainment questionnaire
- Stroke Impact Scale

Secondary ID(s)

U1111-1167-4386

Source(s) of Monetary Support

Universitätsklinik für Neurologie

Ethics review

Status: Approved
Approval date: 15/12/2014
Contact:

[e-mail]

Ethik-Kommission der Otto-von-Guericke-Universität an der Medizinischen Fakultät und am Universitätsklinikum Magdeburg A.ö.R.

[phone]

[e-mail]

Results

• URL: http://drks.de/search/en/trial/DRKS00007832#studyResults