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Combined Electrical Stimulation of the Brain and Muscles for patients with Spinal Cord Injury: an experimental study

Transcranial Electrical Stimulation combined with Neuromuscular Electrical Stimulation in patients with Spinal Cord Injury: quasi-experimental study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-7w3jw35
Enrollment
Unknown
Registered
2024-03-05
Start date
2024-04-01
Completion date
Unknown
Last updated
2026-01-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Spinal Cord Diseases

Interventions

This is an uncontrolled, single-arm clinical trial, without blinding or randomization. Twelve participants (in a single group) will undergo twelve weeks of weekly training, once per week, for twenty m

Sponsors

Universidade Estadual de Campinas
Lead Sponsor
Universidade Estadual de Campinas
Collaborator

Eligibility

Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Spinal cord injury at any neurological level from C2 to T12 for at least one year. Stable neurological deficit for at least 6 months. Over 18 years of age. Both sexes. Pain at the neurological level of injury or below with a Neuropathic Pain 4 (DN4) scale equal to or greater than 4

Exclusion criteria

Exclusion criteria: Cognitive impairment that prevents the safe completion of electrode training. Neuropathic pain prior to spinal cord injury. Other chronic pain syndromes, especially fibromyalgia and complex regional pain syndrome. Extensive skin lesions that do not allow electrode coupling. Decompensated mood disorder. Epilepsy. Use of a pacemaker

Design outcomes

Primary

MeasureTime frame
It is expected to observe improvement in chronic pain, as assessed by the Neuropathic Pain Symptoms Inventory (NPSI), McGill Pain Questionnaire (MPQ), and Pain Quality Assessment Questionnaire (PQAS), with a minimum variation of 5% between pre- and post-intervention measurements

Secondary

MeasureTime frame
It is expected to observe improvement in quality of life, as assessed by the Short-form Health Survey-36 (SF-36) and Quality of Life Index Spinal Cord Injury III (QoLSCI), with a minimum variation of 5% between pre- and post-intervention measurements;It is expected to observe an increase in muscle strength, as assessed by the peak isometric force, with a minimum variation of 5% between pre- and post-intervention measurements;It is expected to observe a lowering of the level of sensory injury, as assessed by the American Spinal Cord Injury Association Impairment Scale (AIS), with a reduction of at least one sensory dermatome between pre- and post-intervention measurements

Countries

Brazil

Contacts

Public ContactJean De Souza

Universidade Estadual de Campinas

souzajm@unicamp.br+55(19)3521-9211

Outcome results

None listed

Source: REBEC (via WHO ICTRP)