Efficacy and Safety of Growth Hormone Treatment in Spinal Cord Injury

Hospital Nacional de Parapléjicos de Toledo76 enrolled

Overview

Objectives: To evaluate the efficacy and safety of one year treatment based on daily doses of exogenous growth hormone (GH) in patients with traumatic spinal cord injury. The first six months the pharmacological treatment will be associated to rehabilitation treatment. The main hypothesis is that GH can improve motor function of patients with traumatic spinal cord injury below the lesion level. The hypothesis is based on possible effects of GH at muscle and synaptic level. GH can also promote axonal growth and regeneration. Design: Clinical trial placebo-controlled, double-blind intervention with blind evaluation by third parties and blinding in the analysis of data (triple-blind design). Duration of intervention and monitoring: 364 days. Primary outcome measures. Changes of the American Spinal Injury Association (ASIA) scale (motor score)

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Spinal Cord Injury

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Traumatic Spinal cord injury * Incomplete (ASIA scale B or C) * Level of injury: Between C4 and D12 * More than 18 months from the SCI injury. Exclusion Criteria: * Non traumatic Spinal cord injury * Complete SCI (ASIA A) * Incomplete (ASIA D or E) * Less than 18 months from the SCI * Intensive Care Unit (ICU) staying for a period of 2 months or more * More than 3 urological infections in the last year * Pneumonia in the 6 months prior to the study * Severe respiratory failure * History of head trauma * Severe psychiatric disorder * A history of heart disease, diabetes or hypertension * Concomitant Neurological Diseases * Regular use of substances of abuse * Patients with severe kidney and / or liver failure. * Patients who can not be included in an intensive rehabilitation program * Patients who are pregnant or breast-feeding * History of malignancy * Impossibility to obtain informed consent

Outcomes

Primary Outcomes

Motor Score of the American Spinal Injury Association (ASIA) scale

Motor score of the ASIA scale reports the strenght of 10 key muscles in each body side (5 key muscles in upper limb and 5 key muscles in lower limb). The strenght is rated between 0 and 5 (Medical Research Council-MRC scale). The ASIA motor score range is between 0 and 100 (normal).

Time frame: 12 months

Secondary Outcomes

ASIA

ASIA grades

Time frame: 12 months

ASIA sensory score

Time frame: 12 months

Spasticity

Penn scale and Ashworth scale

Time frame: Baseline, 15 days, 6 months, 12 months

Pain

Visual analogic scale (VAS)

Time frame: Baseline, 15 days, 6 months, 12 months

Independence Measures and Quality of life

Spinal Cord Indipendence Measures (SCIM) and the Quality of Life Questionnaire (EQ 5D)

Time frame: 12 months

Neurophysiological Measures

Motor Evoked Potentials, Somatosensory Evoked Potentials, Motor Neurography

Time frame: 6 months and 12 months

Safety

Recording of any adverse event, full blood and urine examination

Time frame: 15, 30, 60, 90, 120, 150, 180, 360 days

Efficacy and Safety of Growth Hormone Treatment in Spinal Cord Injury

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes