Triple therapy to boost stroke recovery in Azerbaijan: combining brain stimulation, medication, and physiotherapy
| ISRCTN | ISRCTN45191532 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN45191532 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | Nil known |
| Sponsor | Azerbaijan Medical University |
| Funder | Azerbaijan Scientific Research Institute of Medical Rehabilitation |
- Submission date
- 30/01/2025
- Registration date
- 13/02/2025
- Last edited
- 12/02/2025
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Circulatory System
Plain English summary of protocol
Background and study aims
This research will study the effectiveness of cerebrolysin in combination with physical methods of treatment, including transcranial direct current stimulation (tDCS), kinesitherapy, and massage, in the rehabilitation of patients with cerebral stroke.
Who can participate?
Patients aged between 18 and 85 years old with acute ischemic stroke in the early recovery period (90-180 days) and late (from 6 months to a year)
What does the study involve?
The investigators hypothesize that the triple therapy concept in this study (cerebrolysin plus tDCS plus standardized physiotherapy) will be superior in improving the patient's motor skills and quality of life after stroke compared to traditional physiotherapy plus tDCS alone.
What are the possible benefits and risks of participating?
Benefits and risks not provided at registration
Where is the study run from?
The Azerbaijan Scientific Research Institute of Medical Rehabilitation
When is the study starting and how long is it expected to run for?
March 2024 to March 2026
Who is funding the study?
The Azerbaijan Scientific Research Institute of Medical Rehabilitation
Who is the main contact?
Mrs Sadagat Huseynova, hsadagat@gmail.com, huseynova-sadagat@rambler.ru
Contact information
Public, Scientific, Principal investigator
Azerbaijan Scientific Research Institute of Medical Rehabilitation
Khatai Avenue, 9
Baku, Narimanov
AZ1008
Azerbaijan
| Phone | +994 12 496-07-06, +994 12 496-07-47, +994 12 496-07-48 |
|---|---|
| hsadagat@gmail.com |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Single-centre interventional randomized open-label study |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | CINEMA study - cerebrolysin neuro modulation Azerbaijan |
| Study acronym | CINEMA |
| Study objectives | The investigators hypothesize that the innovative triple therapy concept in this study (cerebrolysin plus transcranial direct current stimulation [tDCS] plus standardized physiotherapy) will be superior in improving the patient's motor skills and quality of life after stroke compared to traditional physiotherapy plus tDCS alone. |
| Ethics approval(s) |
Approved 23/09/2024, Ethics Committee of Azerbaijan Medical University (Samad Vurghun, Baku, AZ1022, Azerbaijan; +994125973898; info@amu.edu.az), ref: 35 |
| Health condition(s) or problem(s) studied | To study the effectiveness of the use of cerebrolysin in combination with physical methods of treatment (direct current stimulation, kinesitherapy, massage) in the rehabilitation of patients with cerebral stroke. |
| Intervention | This is a single-centre interventional randomised open-label study design: The study will involve 60 patients with cerebral stroke (CS) in the early (from 3 to 6 months) and late (from 6 months to a year) recovery periods of the disease. Patients will be divided into 2 groups. 1. Patients in group I (main) will receive injections of cerebrolysin - 30 ml diluted in 100 ml of NaCl solution, intravenously, by drop infusion (14 days). On the same day, patients will receive transcranial direct current stimulation (tDCS) kinesiotherapy (proprioceptive neuromuscular facilitation (PNF), constraint-induced movement (Ci) therapy) and massage. 2. Patients of group II (control, comparison group) will receive only tDCS kinesiotherapy and massage. Methods of kinesitherapy (task-oriented approach): 1. Treatment by constraint-induced movement, Ci-therapy. 2. Method of proprioceptive muscle facilitation - PNF. |
| Intervention type | Mixed |
| Primary outcome measure(s) | Functional activity of the upper limbs is measured using the Action Research Arm Test (ARAT) on the 14th day after the start of treatment |
| Key secondary outcome measure(s) | The following secondary outcome measures are assessed on day 15: 1. The severity of neurological deficit measured using the NIH Stroke Scale/Score (NIHSS) scale 2. Daily life activity measured using the Barthel scale (and Rankin scale) 3. Cognitive functions measured using the Mini-Mental State Examination (MMSE) scale (or Functional Independence Measure (FIM), Montreal Cognitive Assessment (MoCA)) 4. Functional activity of the upper limbs measured using the ARAT 5. Electrical activity of the muscles measured using electromyography (EMG) |
| Completion date | 01/03/2026 |
Eligibility
| Participant type(s) | Health professional |
|---|---|
| Age group | Mixed |
| Lower age limit | 18 Years |
| Upper age limit | 85 Years |
| Sex | All |
| Target sample size at registration | 60 |
| Key inclusion criteria | 1. Ischemic stroke patients 2. Non-transient arm paresis 3. Aged 18-85 4. Intact cortico-spinal tract 5. Baseline NIHSS above 8. |
| Key exclusion criteria | 1. Progressive or unstable stroke 2. Preexisting or active major neurological or psychiatric disease 3. History of significant alcohol or drug abuse within the previous 3 years 4. Advanced liver, kidney, cardiac, or pulmonary disease 5. Terminal medical diagnosis with an expected survival of <l year 6. Substantial decrease in alertness at the time of randomization 7. Any condition that would represent a contraindication for cerebrolysin administration, including allergy 8. Pregnancy or lactation 9. Participation in another therapeutic study of stroke or stroke recovery |
| Date of first enrolment | 01/03/2024 |
| Date of final enrolment | 01/03/2026 |
Locations
Countries of recruitment
- Azerbaijan
Study participating centre
Baku
AZ1073
Azerbaijan
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Available on request |
| IPD sharing plan | The datasets generated during and/or analysed during the current study will be available upon request from Mrs Huseynova Sadagat, hsadagat@gmail.com, huseynova-sadagat@rambler.ru |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
30/01/2025: Study's existence confirmed by the Ethics Committee of Azerbaijan Medical University.
