rTMS-stroke-phase I

Phase 1

Recruiting

• Conditions: Stroke

• Registration Number: RPCEC00000076
• Lead Sponsor: International Center for Neurological Restoration

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-05-29
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Measures

Name	Time	Method
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