Clinical trial NCT04790149: Effectiveness of NEUROM Combined With tDCS to Guide Motor Recovery in Paraplegics Patients
Official title: Effectiveness of NEUROM Protocol Combined With tDCS to Induce and Guide Motor Recovery in Incomplete Paraplegics Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Spinal Cord Injuries
Keywords: Spinal Cord Injury
Neurorehabilitation
Motor and Sensory Recovery
Physical Therapy
Lead sponsor: Lebanese University
Sponsor class: OTHER
First posted: 2021-03-10
Enrollment: 56
Sex: ALL
Minimum age (years): 25
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 3 groups receiving parallel different interventions
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: Inclusion Criteria:

* 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)
* at least 3 months' post-injury.

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.

Primary outcomes:
measure: American Spinal Injury Association Scale - ASIA
timeFrame: Baseline
measure: American Spinal Injury Association Scale - ASIA
timeFrame: during the intervention
measure: American Spinal Injury Association Scale - ASIA
timeFrame: immediately after the intervention
measure: Vividness of motor imagery questionnaire (VMIQ)
timeFrame: Baseline
measure: Vividness of motor imagery questionnaire (VMIQ)
timeFrame: during the intervention
measure: Assessment of movement attempt and execution
timeFrame: Baseline
measure: Assessment of movement attempt and execution
timeFrame: During the intervention
measure: Assessment of movement attempt and execution
timeFrame: Immediately after the intervention
measure: Ashworth Scale
timeFrame: Baseline
Secondary outcomes:
measure: The visual analog scale (VAS)
timeFrame: Baseline
Other outcomes:
Locations:
city: Beyrouth
country: Lebanon
facility: Lebanese University
Study officials:
affiliation: Lebanese University
name: Ahmad Rifai Sarraj, PhD
role: PRINCIPAL_INVESTIGATOR
References: