Effects of Transcranial Magnetic Stimulation Associated to Sensory Therapy for Treatment of Motor Function of Upper Limb of Stroke Patients
NCT ID: NCT03329807
Last Updated: 2017-11-06
Study Results
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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UNKNOWN
NA
40 participants
INTERVENTIONAL
2017-07-20
2019-08-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Experimental rTMS and conventional sensory therapy
Device: Repetitive Transcranial Magnetic Stimulation (rTMS) The subjects were seated in a comfortable chair with head and arm rests. Focal TMS of the somatosensory cortex was performed with a 70-mm figure-8 coil attached to magnetic stimulator stimulation parameters : frequency of 10Hz on the injured hemisphere by stroke; 1500 pulses with an intensity of 120% of MT 10 sessions of rTMS, one per day, always before conventional sensory therapy. rTMS it will be applied for about 20 minutes, five days per week.
Behavioral: conventional sensory therapy All patients will receive the same protocol of Sensory Therapy that will consist of the behavioral methods of Active Sensory Reeducation, Mirror Therapy and passive method that will consist in the administration of electric current by TENS (sensitive threshold). Participants will be instructed not to perform active muscular contraction during Interventions. The protocol it will be applied for about 60 minutes, five days per week.
Transcranial Magnetic Stimulation
The subjects were seated in a comfortable chair with head and arm rests. Focal TMS of the somatosensory cortex was performed with a 70-mm figure-8 coil attached to magnetic stimulator stimulation parameters : frequency of 10Hz on the injured hemisphere by stroke; 1500 pulses with an intensity of 120% of MT 10 sessions of rTMS, one per day, always before conventional sensory therapy. rTMS it will be applied for about 20 minutes, five days per week.
conventional sensory therapy
Behavioral: conventional sensory therapy All patients will receive the same protocol of Sensory Therapy that will consist of the behavioral methods of Active Sensory Reeducation, Mirror Therapy and passive method that will consist in the administration of electric current by TENS (sensitive threshold). Participants will be instructed not to perform active muscular contraction during Interventions. The protocol it will be applied for about 60 minutes, five days per week.
Sham Comparator
control The control group received rTMS sham stimulation (same area as the experimental group) in 10 sessions, 5 days per week, and Sham conventional sensory therapy in the paretic upper limb The sham stimulation will be applied so that it is perceived by the patient as real. Thus during the rTMS sessions the same procedures of the active rTMS sessions will be applied, however the stimulation will be performed with two coils: a coil coupled to the stimulator positioned away from the patient's scalp, yet not visible to the patient so that the patient Perceive only the characteristic sound of the stimulation, and the other coil, disconnected from the stimulator positioned on the volunteer's head.
For the SHAM group, all sensory therapy activities will be performed, however only with the non-affected member. Patients will be convinced that a transfer of skills from one member to another can occur through the connections between the hemispheres.
conventional sensory therapy
Behavioral: conventional sensory therapy All patients will receive the same protocol of Sensory Therapy that will consist of the behavioral methods of Active Sensory Reeducation, Mirror Therapy and passive method that will consist in the administration of electric current by TENS (sensitive threshold). Participants will be instructed not to perform active muscular contraction during Interventions. The protocol it will be applied for about 60 minutes, five days per week.
Interventions
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Transcranial Magnetic Stimulation
The subjects were seated in a comfortable chair with head and arm rests. Focal TMS of the somatosensory cortex was performed with a 70-mm figure-8 coil attached to magnetic stimulator stimulation parameters : frequency of 10Hz on the injured hemisphere by stroke; 1500 pulses with an intensity of 120% of MT 10 sessions of rTMS, one per day, always before conventional sensory therapy. rTMS it will be applied for about 20 minutes, five days per week.
conventional sensory therapy
Behavioral: conventional sensory therapy All patients will receive the same protocol of Sensory Therapy that will consist of the behavioral methods of Active Sensory Reeducation, Mirror Therapy and passive method that will consist in the administration of electric current by TENS (sensitive threshold). Participants will be instructed not to perform active muscular contraction during Interventions. The protocol it will be applied for about 60 minutes, five days per week.
Eligibility Criteria
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Inclusion Criteria
* absence of cognitive deficits (evaluated by Mini Mental State Examination, score ≥ 20 - FOLSTEIN 1975);
* partially preserved motor functions (evaluated by the Fugl-Meyer Scale, score between 14 and 60, due to the necessary movements to be performed during the intervention);
* partially preserved sensorial (evaluated by the Fugl-Meyer Scale, score between 2 and 10 in the sensorial item , Indicating subjects with sensorial alterations but without extinction of the sensation) (MAKI, QUAGLIATO, CACHO, et al., 2006);
* patients who, through exposure to electric current by TENS, perceive the electrical stimulation in the palm, back of the hand and ventral forearm will be included.
Exclusion Criteria
* peripheral neuropathies;
* leprosy;
* fibromyalgia;
* rheumatoid arthritis;
* other upper and lower motor neuron pathologies;
* sensitizing skin diseases;
* history of psychiatric illnesses including drug and alcohol abuse;
* traumato-orthopedic deformities installed in upper limbs;
* those who are performing some rehabilitation treatment during the collection (Physiotherapy and / or Occupational Therapy) will not participate in the research.
In addition, for the application of rTMS:
* patients with intracranial metal implants will be excluded;
* pregnancy;
* history of seizures and / or epilepsy;
* use of medication that interferes with cortical excitability.
30 Years
75 Years
ALL
No
Sponsors
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Universidade Federal de Pernambuco
OTHER
Responsible Party
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Kátia Monte-Silva
Clinical Professor; PHD
Locations
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Federal University of Pernambucano
Recife, Pernambuco, Brazil
Aristela de Freitas Zanona
Recife, , Brazil
Countries
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Facility Contacts
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Katia Monte-Silva, phd
Role: primary
ARISTELA ZANONA
Role: primary
References
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de Freitas Zanona A, Romeiro da Silva AC, Baltar do Rego Maciel A, Shirahige Gomes do Nascimento L, Bezerra da Silva A, Piscitelli D, Monte-Silva K. Sensory and motor cortical excitability changes induced by rTMS and sensory stimulation in stroke: A randomized clinical trial. Front Neurosci. 2023 Jan 25;16:985754. doi: 10.3389/fnins.2022.985754. eCollection 2022.
de Freitas Zanona A, Romeiro da Silva AC, do Rego Maciel AB, Gomes do Nascimento LS, Bezerra da Silva A, Bolognini N, Monte-Silva K. Somatosensory Cortex Repetitive Transcranial Magnetic Stimulation and Associative Sensory Stimulation of Peripheral Nerves Could Assist Motor and Sensory Recovery After Stroke. Front Hum Neurosci. 2022 Apr 11;16:860965. doi: 10.3389/fnhum.2022.860965. eCollection 2022.
Other Identifiers
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rTMS_sensory_therapy_stroke
Identifier Type: -
Identifier Source: org_study_id