Grasping Rehabilitation Using Motor Imagery With or With no Neurofeedback After Tetraplegia (TETRAMINF)

Civil Hospices of Lyon

Status: Enrolling

Conditions: Individuals With C6-C7 Tetraplegia (AIS A or B)

Treatments: Behavioral: Motor imagery (MI); Behavioral: Control (C); Behavioral: Motor imagery combined with neurofeedback (MINF)

Study type: Interventional

Funder types: Other

Identifiers

NCT03190863

69HCL17_0016

Details and patient eligibility

About

Motor imagery has shown promising results to optimize tenodesis grasp in individuals with C6-C7 tetraplegia. However, efficacy of using motor imagery to improve grasping after tetraplegia requires further study with higher level of evidence. In addition, controlling covert practice remains difficult due to the absence of overt movements. However, similar brain activity measured during both over and cover movements makes possible to provide visual information about the covert practice performance using neurofeedback.

The Investigators thus designed this multicentric randomized controlled trial to investigate the effect of motor imagery with or with no visual neurofeedback on grasping capabilities after C6-C7 tetraplegia. They hypothesized that providing neurofeedback based on brain activity measured by electroencephalography namely knowing the covert practice performance would results in greater grasping improvement in response to practice as compared to motor imagery practice alone.

Enrollment: 21 estimated patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Volunteer individuals with C6-C7 tetraplegia with complete finger flexor paralysis restricting grasping capabilities to the tenodesis.
• Consent to participate to the study after receiving clear, loyal and appropriate information.
• Aged between 18 and 55 years.
• Time since spinal cord injury above 6 months
• Stabilized condition in particular sensori-motor deficit.
• Sitting position for more than 1 hour
• Able to imagine movement
• Health care beneficiary

Exclusion criteria

• Long-lasting autonomic disorders while sitting (orthostatic hypotension and/or blood pressure instability) limiting sitting position to less than 1 hour.
• Upper limb pain for either mechanic or neuropathic reasons preventing all grasping movement and/or the ability to imagine those movements.
• Restricted wrist and finger range of motion preventing the tenodesis grasp.
• Patient after surgical tendon transfer that improved grasping capabilities (e.g. active finger flexion).
• Ongoing participation in another research that aim to evaluate an intervention likely to improve the neurological or functional recovery introducing an experimental bias.
• Specific contraindication to Magnetoencephalography with the presence of metallic fragments inside the body such as pace-maker, neurostimulator, cochlear implants, steel dental implant and osteosynthesis material only applicable to the participants included in Lyon hospital center (n=15).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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21 participants in 3 patient groups

Motor imagery combined with neurofeedback (MINF)

Experimental group

Treatment:

Behavioral: Motor imagery combined with neurofeedback (MINF)

Motor imagery (MI)

Active Comparator group

Treatment:

Behavioral: Motor imagery (MI)

Control (C)

Sham Comparator group

Treatment:

Behavioral: Control (C)