Baclofen for Spinal cord injury

Inclusion criteria

• {"criterion_text":"- Cervical SCI neurological level C1-Th1\n- Functionally hindering generalized spasticity of the upper extremities with insufficient effect or too many side effects of oral spasmolytics and/or local treatments\n- American Spinal Injury Association (ASIA) Impairment Scale: A,B,C,D\n- > 1 year after onset of SCI\n- Over 18 years old\n- No progressive disease\n- Stabile medical situation for undergoing the ITB-trial and a final implantation of a baclofen pump after positive test\n- No muscle or nerve blocks < 6 months for start of study"}

Exclusion criteria

• {"criterion_text":"- Pregnancy\n- Women of child bearing potential\n- Nursing women\n- Allergy baclofen\n- Contra indication ITB (increased bleeding tendency, increased intracranial pressure, severe pressure ulcer)\n- Oral anticoagulants\n- Severe depression\n- excessive alcohol use\n- Patients depending on ventilation\n- Not adequately treated SAS\n- PcCO2 > 6,5 KPa"}

Primary endpoints

• {"endpoint_text":"- The primary endpoint of the study is treatment safety, which is defined as PcCO2 between 4,7 kPa and 6,5 kPa and an AHI < 15 without complaints of SAS in patients without SAS and an AHI < 5 in patients with treated SAS. If patients use a CPAP device, it may be adjusted to stay within the safe margin. This adjustment will be registered. The spirometry is not used for safety reasons but to determine the effect of ITB on pulmonary function","definition_or_measurement_approach":"Defined as PcCO2 between 4.7 kPa and 6.5 kPa and AHI thresholds: AHI < 15 without complaints of SAS in patients without SAS, and AHI < 5 in patients with treated SAS. CPAP adjustments may be made and will be registered. Spirometry used to determine effect on pulmonary function but not used for safety."}

Secondary endpoints

• {"endpoint_text":"- Secondary endpoints are the amount of spasticity, patients satisfaction and patients level of function and activities.","definition_or_measurement_approach":"No specific measurement instruments or timepoints are detailed in the record; endpoints described as amount of spasticity, patient satisfaction, and patient level of function and activities."}

Netherlands

Earliest CTIS Part Ii Submission Date

03-05-2024

Latest Decision Or Authorization Date

06-05-2024

Processing Time Days

3

Number Of Sites

2

Number Of Participants

11

Primary sponsor

Full Name

Roessingh Centrum Voor Revalidatie

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Netherlands

Third parties

• {"country":"","full_name":"neurobionic foundation","duties_or_roles":"Source of monetary support","organisation_type":""}
• {"country":"","full_name":"Medtronic","duties_or_roles":"Source of monetary support","organisation_type":""}
• {"country":"","full_name":"Roessingh","duties_or_roles":"Source of monetary support","organisation_type":""}