Active tDCS Versus Sham tDCS for Upper Limb Recovery in Incomplete Tetraplegic Patients

NCT05390853 | Recruiting

• 1 other identifier: CE AVEC_96-2022-SPER-AUSLIM
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Spinal Cord Injury (SCI) at the cervical level results in motor and sensory impairment below the lesion level and may determine a consistent loss of the use of the upper limbs, with a substantial impact on daily life activities. Therefore, functionality recovery of the upper limbs, of the hands in particular, represents a priority rehabilitation target. Studies in the literature show that the most relevant recovery occurs in the first months after SCI and that neuromodulation techniques may facilitate it. Transcranial Direct Current Stimulation (tDCS ) is a non-invasive neuromodulation technique. The present pilot, randomized controlled study aims at exploring the feasibility and efficacy of an early application of tDCS, in addition to the traditional physiotherapy treatment for the functional recovery of the upper limb, in incomplete traumatic tetraplegic subjects in the sub-acute phase after SCI occurrence. Patients hospitalized at the Montecatone Rehabilitation Institute are randomly assigned to Active tDCS or Sham tDCS.

Conditions

Spinal Cord Injury Cervical

Keywords

Neuromodulation; Transcranial Direct Current Stimulation; tDCS; Upper limb; Functional recovery; Early rehabilitation; Incomplete tetraplegia

Outcome Measures

Primary Outcomes (1)

• Change in motor function, after the tDCS treatment period completion

  Motor function (i.e. muscle strength) of the target upper limb, determined according to the Medical Research Council /International Classification for the Surgery of the Tetraplegic Hand (MRC/ICSTH)

  Baseline 1 (initial visit); Baseline 2 (second visit, 2 weeks after Baseline 1); just before tDCS session n.1 (4 weeks after Baseline 1); just after tDCS session n.20 (6 weeks after Baseline 1)

Secondary Outcomes (8)

• Permanence of motor function, 4 weeks after the tDCS treatment period completion

  Just after tDCS session n.20 (6 weeks after Baseline 1); 4 weeks after tDCS session n.20 (10 weeks after Baseline 1)

• Change in strength, sensitivity and grip, up to 4 weeks after the tDCS treatment period completion

  Baseline 1 (initial visit); Baseline 2 (second visit, 2 weeks after Baseline 1); just before tDCS session n.1 (4 weeks after Baseline 1); just after tDCS session n.20 (6 weeks after Baseline 1); 4 weeks after tDCS session n.20 (10 weeks after Baseline 1)

• Change in spasticity, up to 4 weeks after the tDCS treatment period completion

  Baseline 1 (initial visit); Baseline 2 (second visit, 2 weeks after Baseline 1); just before tDCS session n.1 (4 weeks after Baseline 1); just after tDCS session n.20 (6 weeks after Baseline 1); 4 weeks after tDCS session n.20 (10 weeks after Baseline 1)

• Change in motor function and muscle activity during rest activity, from the beginning of the tDCS treatment period until 4 weeks after its completion

  just before tDCS session n.1 (4 weeks after Baseline 1); just after tDCS session n.20 (6 weeks after Baseline 1); 4 weeks after tDCS session n.20 (10 weeks after Baseline 1)

• Change in Motor Evoked Potentials, from the beginning of the tDCS treatment period until 4 weeks after its completion

  just before tDCS session n.1 (4 weeks after Baseline 1); just after tDCS session n.20 (6 weeks after Baseline 1); 4 weeks after tDCS session n.20 (10 weeks after Baseline 1)

Study Arms (2)

Active tDCS (A)

EXPERIMENTAL

Two daily tDCS sessions for 5 days a week, for 2 consecutive weeks, are carried out, simultaneously with the usual rehabilitation physiotherapy of the upper limbs. Patients will receive the usual rehabilitation physiotherapy of the upper limbs at least in the 4 weeks before and in the 4 weeks after the tDCS treatment period too.

Procedure: Active tDCS

Sham tDCS (S)

PLACEBO COMPARATOR

Two daily tDCS sessions for 5 days a week, for 2 consecutive weeks, are carried out, simultaneously with the usual rehabilitation physiotherapy of the upper limbs. Patients will receive the usual rehabilitation physiotherapy of the upper limbs at least in the 4 weeks before and in the 4 weeks after the tDCS treatment period too.

Procedure: Sham tDCS

Interventions

Active tDCS PROCEDURE

tDCS application is anodic, in the M1 area (Primary Motor Cortex) right or left, contralateral to the pre-defined target limb. The cathode is positioned in the supraorbital area, contralateral to the anode. Active stimulation is carried out with a current intensity of 2 milliAmpere. Each tDCS session lasts 20 minutes. tDCS is administered simultaneously during the first 20 minutes of the usual upper limb rehabilitation physiotherapy, which will continue for a further 20 minutes. During the whole study period (10 weeks) each patient is not subjected to any focal treatments in the target upper limb. In the study period, the contralateral limb is rehabilitated and evaluated according to usual practice.

Active tDCS (A)

Sham tDCS PROCEDURE

tDCS application is anodic, in the M1 area (Primary Motor Cortex) right or left, contralateral to the pre-defined target limb. The cathode is positioned in the supraorbital area, contralateral to the anode. Sham stimulation is carried out through a dedicated program, which increases the current for several seconds up to the target intensity and then decreases it gradually in a few seconds, so that subjects experience the same itching and tingling experience as in active stimulation, but they do not receive any significant therapeutic currents. Each tDCS session lasts 20 minutes. tDCS is administered simultaneously during the first 20 minutes of the usual upper limb rehabilitation physiotherapy, which will continue for a further 20 minutes. During the whole study period (10 weeks) each patient is not subjected to any focal treatments in the target upper limb. In the study period, the contralateral limb is rehabilitated and evaluated according to usual practice.

Sham tDCS (S)

Eligibility Criteria

• Age: 18 Years - 74 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Traumatic SCI;
• SCI neurological level, according to the American Spinal Injury Association (ASIA) definitions, from C3 to C7, included;
• incomplete SCI (i.e. ASIA Impairment Scale: B, C or D);
• distance from the SCI event: from 3 to 6 months;
• residual motor ability of the target upper limb;
• stable clinical conditions;
• tolerance to sitting position for at least 45 minutes;
• subjects capable and collaborating, able to give informed consent in person.

You may not qualify if:

• presence of implanted devices (e.g. pacemakers, intrathecal infusers, neurostimulators, hearing aids);
• positive history of brain lesions;
• presence of cerebral metallic implants (clips) or intracranial implants (e.g. ventriculoperitoneal shunt);
• history of epilepsy or previous state of epileptic disease;
• mechanical ventilation in place;
• history of psychotic disorders;
• history of severe neurodegenerative disease;
• concomitant pre-existing clinical conditions that may interfere with movements of the target arm or hand (e.g. severe osteoarthritis, joint injuries, plexus injuries, peripheral nerve injuries, partial amputations);
• use of antiepileptic drugs blocking Sodium o Calcium channels (e.g. Carbamazepine) or N-Methyl-D-Aspartate receptor antagonists (e.g. Dextromethorphan);
• history of drugs abuse;
• further contraindications to the use of TMS for PEMs elicitation (e.g. migraine with aura, permanent head / face tattoos);
• presence of brain tumor;
• pregnancy in progress.

Sponsors & Collaborators

• Montecatone Rehabilitation Institute S.p.A.: lead

Study Sites (1)

Montecatone Rehabilitation Institute S.p.A.

Imola, BO, 40026, Italy

RECRUITING

Study Officials

• Silvia Olivi, MD

  Montecatone Rehabilitation Institute S.p.A.

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Silvia Olivi, MD

CONTACT

+39 0542 632811; silvia.olivi@montecatone.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: After selection, enrollment and basal assessments, patients are randomized just before the first tDCS session by the professional who will apply the tDCS and will thus be the only one knowing the assigned intervention during the study
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 20, 2022
• First Posted: May 25, 2022
• Study Start: May 24, 2023
• Primary Completion: October 1, 2025
• Study Completion: November 1, 2025
• Last Updated: October 22, 2024

Record last verified: 2024-10

Locations

IT (1)