rTMS-stroke-phase I

General information

Section to complete general information about the trial: scientific and public title, protocol identifiers, sponsors and Source(s) of Monetary or Material Support.

Scientific title:

Therapeutic repetitive Transcranial Magnetic Stimulation in patients with stroke

Secondary indentifying numbers:

CIREN.02/2008

Issuing authority of the secondary identifying numbers:

International Center for Neurological Restoration

Source(s) of monetary or material support:

International Center for Neurological Restoration

Authorization for beginning

Section to complete information about the regulatory approval of clinical trial: regulatory agency name, approval date and reference number in the agency.

Regulatory instance to authorize the initiation of the study:

Only approved by Ethics Committees

Principal investigator

Section to complete information about Email address, telephone number and postal address of the Principal Investigator.

First name:

Dr. Lázaro Gómez Fernández

Last name:

Not entered

Affiliation:

Not entered

Postal address:

Not entered

City:

Not entered

País:

Not entered

Zip Code:

Not entered

Email address:

email@not.entered

Clinical sites to participate

Section to complete the data related to the clinical sites involved in the trial: site and responsible investigator for every site.

Countries of recruitment:

Cuba

Research ethics committees:

Ethic Committee, from the International Center for Neurological Restoration, May 6th 2008

Recruitment status

Section to complete information about the recruitment status and the date of first enrolment subject

Recruitment status:

Recruiting

Date of first enrollment:

25/05/2008

Health condition and Intervention

Section to complete information about the primary medical condition(s) or problem(s) studied and, a characteristics of the intervention(s).

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.

Outcomes and Timepoint

Section to complete information about primary and secondary outcomes including. It includes the metric or method of measurement used and, the time point for every outcome.

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

Key secondary outcomes:

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

Selection criterias

Section to complete information about the inclusion and exclusion criteria for participant selection, including age and gender.

Gender:

Male/Female

Minimum age:

18

Maximum age:

None

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.

Type of population:

Adults

Type of participant:

Patients

Study design

Section to complete information about the characteristics of the study design.

Type study:

Interventional

Purpose:

Treatment

Allocation:

Randomized controlled trial

Masking:

Double Blind

Control group:

Placebo

Study design:

Parallel

Phase:

1

Target sample size:

30

Contact for public queries

Section to complete information about Email address, telephone number and postal address of the contact who will respond to general queries, including information about current recruitment status

First Name:

Dr. Lázaro

Last Name:

Gómez Fernández

Affiliation:

International Center for Neurological Restoration

Postal Address:

25th avenue, No 15805, %158 y 160. Cubanacán

City:

Havana City

País:

Cuba

Zip Code:

Playa 11300

Telephone:

53 7 2715353

Email :

lazarog@neuro.ciren.cu

Contact for scientific queries

Section to complete information about Email address, telephone number and postal address of the contact who will respond to scientific queries.

First Name:

Dr. Lázaro

Last Name:

Gómez Fernández

Affiliation:

International Center for Neurological Restoration

Postal Address:

25th avenue, No 15805, % 158 and 160.

City:

Havana City

País:

Cuba

Zip Code:

Playa 11300

Telephone:

53 7 2715353

Email :

lazarog@neuro.ciren.cu

Registration and Update

Section to complete information about the name of Primary Registry, date of registration and the unique ID number assigned by the registry (RPCEC).

Primary registry:

RPCEC

Unique ID number:

RPCEC00000076

Date of Registration in Primary Registry:

2009-05-29

Record Verification Date:

2009-05-21 20:00

Link to the spanish version:

Click here

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Ensayos Registrados

Proceso de Registro

rTMS-stroke-phase I

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