rTMS-stroke-phase I

• Register: RPCEC
• Last refreshed on: 29 April 2013
• Main ID: RPCEC00000076
• Date of registration: 29/05/2009
• Primary sponsor: International Center for Neurological Restoration
• Public title: rTMS-stroke-phase I
• Scientific title: Therapeutic repetitive Transcranial Magnetic Stimulation in patients with stroke
• Date of first enrolment: 25/05/2008
• Target sample size: 30
• Recruitment status: Active
• URL: http://registroclinico.sld.cu/trials/RPCEC00000076-En
• Study type: Interventional
• Study design: Randomization: Randomized Controlled Trial Blinding: Double Blind Placebo: Placebo Assignment: Parallel Purpose: Treatment

Countries of recruitment

Cuba

Contacts

• Name: Dr. Lázaro Gómez Fernández
• Affiliation: International Center for Neurological Restoration

• Name: Dr. Lázaro Gómez Fernández
• Affiliation: International Center for Neurological Restoration

Key inclusion & exclusion criteria

Inclusion criteria: Patients with only one stroke from the middle cerebral artery territory and hemiparesia as a sequel Three months or even more of evolution time after stroke Patients hospitalized to be included in the CIREN´s neurological restorative program
Exclusion criteria: Patient with more than one clinical recognized stroke Antecedent of convulsive crisis or presence of active epileptiform activity in the electroencephalogram(EEG)(definned qualitatively by a frequent paroxismal activity and/or high frequency discharges in the conventional EEG, according to expert criteria. Severe congnitive dysfunction that make difficult patient´s collaboration Younger that 18 Pregnant woman Use of electromagnetic prosthesis, like auditive prosthesis or cardiac pacemaker; surgical clips, or any other metallic piece in the head If one or more results from laboratory studies give us new data no suspected from the clinical examination that constitutes a contraindication for the use of this method If in the current condition of the patient, it´s comorbility with other diseases or systemic clinical conditions, the occurrence of a convulsion would deteriorate its health state Even when the investigators do not indentify a contraindication, if it is considered that the patient will not be beneficiated from the treatment for any other reason will be excluded too.

Age minimum: 18
Age maximum: None
Gender: Both

Health Condition(s) or Problem(s) studied

Stroke

Intervention(s)

Thirty hospitalized patients were selected and randomized assigned to 6 different groups. Each one will receive a different transcranial magnetic repetitive stimulation scheme based on stimulation frequency and location. All of them will receive one session per day during 20 days, before the patient go to rehabilitation or occupational therapy activities. Group I: 10 Hz stimulation of motor area from the affected hemisphere Group II: 1 Hz stimulation of motor area from the non-affected hemisphere Group III: 1 Hz stimulation of posterior middle line(placebo) Group IV: intermittent theta burst stimulation of motor area from the affected hemisphere Group V: continuous theta burst stimulation of motor area from the non-affected hemisphere Group VI: a combination of stimulation used in group II and IV.

Primary Outcome(s)

Percentage of patients that no fulfill the complete treatment, during the 20 days Percentage of patients who suffer convulsions, after discharges o spread of excitation, during the 20 days of treatment Percentage of patients who suffer headache, cervicalgia o other minor symptom during the 20 days of treatment

Secondary Outcome(s)

Incidence of epileptiform discharges and its frequency, before and after to complete 20 sessions of rTMS Barthel´s index, before and after treatment, 3 months, 6 and 12 months Scandinavian Scale for Stroke, before and after treatment, 3 months, 6 and 12 months MRC, before and after treatment, 3 months, 6 and 12 months Hamilton Scale, before and after treatment, 3 months, 6 and 12 months

Secondary ID(s)

CIREN.02/2008

Source(s) of Monetary Support

International Center for Neurological Restoration