Effectiveness of NEUROM Combined With tDCS to Guide Motor Recovery in Paraplegics Patients
Condition: Spinal Cord Injuries
MeSH terms: Spinal Cord Injuries
Study type: Interventional

Summary: 
      In a traditional view going back to 1800, spinal cord has been described as a protected
      bundle of nerves that connects the brain to the body. Galen contended that spinal cord
      mediates motor, sensory and some of the autonomic functions below the neck.

      Traumatic Spinal Cord Injury (TSCI) is a catastrophic unexpected and devastating event that
      can be occurred along the spinal column (cervical, thoracic, and lumbar). A global-incident
      rate (2007) is estimated at 23 TSCI cases per million (179312 cases per annum). TSCI can
      often results in a life-threatening condition that includes varying degrees of motor
      paralysis and sensory loss and impairment of bowel, bladder, sexual, and other physiologic
      functions.

      In this study, investigators suggest a new experimental rehabilitative protocol for TSCI
      patients called Neural Motor Recruitment Method (NEUROM). This method is based on the
      mentioned histological and/or functional reorganization model after TSCI, on the MI concepts
      and the targeted sensory inputs related to motor recovery. The hypothesis here is that NEUROM
      can enhance sparing- induced plasticity and increase motor and sensory recovery in SCI
      patients especially when combined to tDCS.
    

Detailed description: 
      PARTICIPANTS Fifty paraplegic patients will be recruited from inpatient rehabilitation
      hospitals. The patients will be treated at Rahma Hospital for Rehabilitation in Tripoli and
      Physical Therapy Center of the Faculty of Public Health-I in Hadath.

      Main inclusion criteria will be age between 18-30 years, diagnosis of chronic incomplete
      lower dorsal (below Th10) or lumbar spinal cord injury as defined by the American Spinal
      Injury Association Impairment scale classification (AIS B, C or D) and at least 3 months'
      post-injury. Ethical committee's approval will be obtain from the Lebanese University
      official ethical committee and informed consent will be obtained from all participants with
      respect the the Declaration of Helsinki ethical considerations.

      Exclusion criteria included neuropsychiatric comorbidities; traumatic brain injury (TBI);
      involvement in any specific program of rehabilitation other than the conventional protocol
      since his injury; contraindications to tDCS such as metal in the head or implanted brain
      medical devices. Patients with history of seizure, use of medications containing sodium
      channel blocker such as carbamazepine and any substance abuse will be excluded from the
      study. Patients with severe spasticity greater then and equal to 3 out of 4 as determined by
      a Modified Ashworth Scale will be also excluded.

      When the experiment will start, patients should have received conventional physiotherapy in
      the physical therapy center, and demonstrated stable lower limb functional scores, thus their
      performance must not change from the end of the conventional therapy until the first baseline
      measurements.

      All subjects will be randomly assigned into three groups: 1) Conventional group (n=20) where
      patients will receive a standardized conventional type of intervention (stretching,
      strengthening, neuro-muscular facilitation), Experimental Group (n=20) receiving the neural
      motor recruitment NEROM and the Transcranial Direct Current Stimulation (tDCS) Group (n=10)
      receiving the NEROM combined to the tDCS.

      All participants will undergo a detailed medical examination with particular attention to the
      subjects of the experimental group who will receive tDCS in order to eliminate any adverse
      effect.

      Before every session, participants will be prepared for the closed-loop rehabilitation
      protocol by a static stretching of 20 minutes in both lower legs especially for the
      hamstrings and the soleus muscles.

      GENERAL EXPERIMENTAL PROCEDURE

      CONVENTIONAL REHABILITATION PROGRAM For the conventional control group, investigators will
      include therapeutic exercises such as: Repetitive neuromuscular facilitation, Passive and
      Active Mobilization, Strengthening, Endurance exercises, and/or musculoskeletal interventions
      (Static and dynamic stretching).

      NEURAL MOTOR RECRUITMENT NEROM Patients of the NEROM and the tDCS groups will receive a daily
      home MI training with 20 minutes of stretching during 7 days. MI training will be
      individually delivered in the same quiet room designed for this purpose. SCI participants
      will lay on their bed facing a 43 inches screen distant from their faces of about 3.5 meters
      with a height of the center of the screen of 1.2 meters from the floor. Screen will show
      5-minutes video of two feet repeating large movements of dorsi- and plantar flexion. The
      instructions given to the subject were detailed and read aloud. During this part, an audio
      computer output guided the subject to feel the movement (as a kinesthetic imagery).

      TRANSCRANIAL DIRECT CURRENT STIMULATION tDCS group will receive NEUROM + tDCS. Transcranial
      Direct Current Stimulation which is a form of non-invasive cortical stimulation will be
      performed. Participants will remain seated in their own wheelchair or will be provided with a
      comfortable chair. The StarstimNE non-invasive wireless tDCS neurostimulator (NE
      Neuroelectrics®, Barcelona, Spain) will be used to deliver the direct current. The StarstimNE
      neurostimulator included a wireless neoprene cap based on the International 10-20 System,
      which will be placed on each participant's head by aligning the central CZ electrode position
      with the vertex. Small Ag/AgCl gelled electrodes, with a surface contact area of 3.14 cm2,
      specific to the StarstimNEdevice (Pi electrodes, Neuroelectrics®), will be used. In all
      sessions, one electrode was placed on the left M1, and the other on the right M1;
      corresponding to C3 and C4 of the International 10-20 EEG system. In one session the anode
      was on the left M1, and the cathode on the right M1, and this is referred as AL-CR montage.
      In other session the anode was on the right M1, and the cathode on the left M1 (AR-CL). In
      the stimulation period, DC current was gradually increased over a 7-s period until it reached
      1 mA, and constant current stimulation was subsequently maintained for a total of 20 min.
      During tDCS, the patient will be asked to perform kinesthetic imagery.

      OUTCOME MEASUREMENT

      The primary outcome will be:

        1. Vividness of motor imagery questionnaire (VMIQ) Participants were asked to indicate the
           vividness of an imagined movement on a 5-point scale: 1 (excellent imagination of the
           movement performance as lively as actual performance), 2 (a good capacity to imagine
           movement performance), 3 (moderate capacity to imagine the performance of a movement), 4
           (a vague or unclear image) or 5 (no image at all).

        2. Assessment of movement attempt and execution The studied motor task is consisted of
           repetitive alternating dorsal and plantar flexion of the right foot (30°-0°-45°) at a
           self-paced rhythm. The ability to attempt moving the foot (motor attempt, MA) was
           assessed as follows. The perceived intensity and frequency of attempted movements was
           rated in a structured interview on phantom sensations, which had been developed for
           evaluating phantom body phenomena, paresthesia and movement sensations in SCI patients.

      The intensity of the feeling to move the feet and the frequency of spontaneous attempts in
      daily life were rated. Answers were noted as qualitative descriptors and both the phenomena's
      frequency and intensity were individually rated using a 6-point scale.

      Ability of attempt to move the right foot with intensity of the feeling (1: very weak; 6:
      very high) and frequency of spontaneous attempt in daily life (1: very rare; 6: very often).

      3. The ASIA motor and sensory examinations will be performed by SCI-experienced physical
      therapists at initial (baseline) and every examination point (week +1, week +2, and week +4).
      Five key muscle groups will be assessed using the ASIA International Standards for
      Neurological Classification of SCI, recorded using a six-point ordinal scale for both lower
      limbs resulting in an ASIA total maximum score of 50. Sensation will be recorded for the 12
      key sensory points using a three-point ordinal scale for both lower limbs (maximum possible
      scores = 48) for light touch (LT) and pin prick (PP) (151).

      4. The visual analog scale (VAS) will be used to obtain a measure of introspective perception
      of movement while watching the movie in the illusion condition.

      Before and after all sessions, subjects will be interviewed about the strength of the
      kinesthetic illusion; subjects will provide answers on the VAS regarding the strength of the
      feeling of actual movement, with "0 mm" indicating that subjects have no illusory sensation
      at all and "100 mm" indicating that they feel exactly as if their own finger was moving.
      Before the first part of the imagery protocol, investigators will instruct KI training and
      confirm that all subjects will report a VAS score greater than 50 mm.

      EXPECTED OUTCOMES Priming of the motor cortex to augment functional benefits with peripheral
      training is relatively new, and therapeutic effects of motor cortex stimulation as an
      intervention alone or combined with peripheral training is reported by only a few
      researchers.

      Research is needed to increase effectiveness of physical rehabilitation in Spinal Cord
      Injury. To date, quality of rehabilitative interventions is poor and therapists need to
      differentiate between therapies with unequal impacts on outcomes. This type of protocol will
      find answers to some clinical questions about the effectiveness of non-conventional
      strategies to decrease disabilities after spinal cord injury as post-SCI patients' status
      will have a negative effect on societal and health system in Lebanon.

      APPLICABILITY This type of protocol will find answers to some clinical questions about the
      effectiveness of non-conventional strategies to decrease disabilities after spinal cord
      injury as post-SCI patients' status will have a negative effect on societal and health system
      in Lebanon.

      Our findings may support that modulating excitatory input of the corticospinal tracts on
      spinal circuits combining with motor imagery and static strategy in a closed-loop
      rehabilitation protocol may be a promising strategy in improving lower limb functions in
      persons with incomplete paraplegia.
    

Intervention name(s): Conventional Rehabilitation; NEUROM + tDCS; NEUROM
Intervention type(s): Other; Other; Other
Intervention description(s): Motor Imagery Training combined with Active functional exercises; NEUROM combined to tDCS; protocol to induce motor recovery
Other intervention name(s): Physical Therapy
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: 3 groups receiving parallel different interventions
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Spinal Cord Injury; Neurorehabilitation; Motor and Sensory Recovery; Physical Therapy