Transcranial Stimulation in Motor Stroke Rehabilitation

NCT ID: NCT02525393

Last Updated: 2015-08-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-03-31

Study Completion Date

2014-07-31

Brief Summary

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Patients were randomized in 3 groups: two intervent groups and a control group. The first group received two weeks of daily session of repetitive Transcranial Magnetic Stimulation (rTMS, 10 sessions) and, at least 6 months after, two weeks of daily transcranial Direct Current Stimulation (tDCS, 10 sessions); the second group received 10 daily session of tDCS and, after at least 6 months, 10 sessions of rTMS; the control group received 10 daily session of sham tDCS.

Physiatric evaluations (ARAT scale), neuropsychological assessment and ERP (P300) were performed before (1 week) and after (1 week) the end of each treatment. Furthermore, all patients underwent follow-up neuropsychological assessment 6 months after the end of each stimulation period and follow-up physiatric evaluation at 3 and 6 months after the end of each stimulation period.

Detailed Description

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Conditions

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Stroke

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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tDCS+rTMS

Stroke patients were treated with an initial two weeks of transcranial direct current stimulation and after six months with two weeks of repetitive transcranial magnetic stimulation.

Group Type EXPERIMENTAL

tDCS

Intervention Type DEVICE

Stroke rehabilitation performed with the aid of a transcranial electrical stimulation device.

rTMS

Intervention Type DEVICE

Stroke rehabilitation performed with the aid of a repetitive transcranial magnetic stimulation device.

rTMS+tDCS

Stroke patients were treated with an initial two weeks of repetitive transcranial magnetic stimulation and after six months with two weeks of transcranial direct current stimulation.

Group Type EXPERIMENTAL

tDCS

Intervention Type DEVICE

Stroke rehabilitation performed with the aid of a transcranial electrical stimulation device.

rTMS

Intervention Type DEVICE

Stroke rehabilitation performed with the aid of a repetitive transcranial magnetic stimulation device.

Sham stimulation

Stroke patients were treated with two weeks of sham transcranial direct current stimulation.

Group Type SHAM_COMPARATOR

Sham

Intervention Type DEVICE

Stroke sham stimulation performed with the aid of a transcranial electrical stimulation device.

Interventions

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tDCS

Stroke rehabilitation performed with the aid of a transcranial electrical stimulation device.

Intervention Type DEVICE

rTMS

Stroke rehabilitation performed with the aid of a repetitive transcranial magnetic stimulation device.

Intervention Type DEVICE

Sham

Stroke sham stimulation performed with the aid of a transcranial electrical stimulation device.

Intervention Type DEVICE

Other Intervention Names

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HDC Stim device Newronica PowerMAG 100 MAG&More HDC Stim device Newronica

Eligibility Criteria

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Inclusion Criteria

* ischemic or hemorrhagic stroke (\> 6 months from the accident)

Exclusion Criteria

* general cognitive impairment (Mini Mental State Examination \< 25), severe functional disability (Barthel Index \< 45),
* psychiatric disorders,
* degenerative neurological disorders,
* epilepsy,
* severe medical conditions,
* having been implanted a drug infusion system, spinal/brain-stimulator, or endovascular coil
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Turin, Italy

OTHER

Sponsor Role lead

Responsible Party

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Federico Dagata

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Federico D'Agata, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Turin, Italy

Locations

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AOU Città della Salute e della Scienza

Turin, , Italy

Site Status

Countries

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Italy

Other Identifiers

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CEI 339

Identifier Type: -

Identifier Source: org_study_id

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