Effects of tDCS Combined With mCIMT or Mental Practice in Poststroke Patients

NCT01879787 | Completed Phase 2 DMC

• 1 other identifier: tDCS_mCIMT_MP_Stroke
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to evaluate systematically and controlled the effectiveness of mental practice techniques and modified constraint- induced movement therapy (mCIMT)in the treatment of post-stroke patients with motor deficit in the upper limb. As well as finding a protocol of transcranial direct current stimulation(tDCS)that will maximize the effects of the practice of mental image and mCIMT. To this end, the subjects included will be submitted to 12 therapy sessions with active or sham tDCS combined with at least one of the following techniques: conventional physiotherapy, mental practice technique or mCIMT

Conditions

Stroke

Keywords

Stroke; transcranial direct current stimulation; constraint-induced movement therapy; mental practice

Outcome Measures

Primary Outcomes (1)

• Change from Fugl-Meyer Assessment of Upper Extremity Motor Function

  The Fugl-Meyer assessment was used to measure recovery of motor control. It is a 226-point scoring system that includes range of motion, pain, sensation, motor function of the upper and lower extremities, and balance.This instrument provides a reliable and valid measure of specific motor function that is also sensitive to change.

  At baseline, 1 month and 2 month

Secondary Outcomes (1)

• Change from Motor Activity Log

  At baseline, 1 month and 2 month

Other Outcomes (1)

• Change from Jebsen-Taylor Hand Function Test

  At baseline, 1 month and 2 months

Study Arms (7)

physiotherapy + anodal tDCS + mCIMT

EXPERIMENTAL

Before a anodal tDCS with duration of 13 minutes and intensity of 1mA applied at the injured motor cortex, the patient will be submitted to a 30 minutes physiotherapy protocol. Lastly the individual will realized a 45 minutes mCIMT protocol. The experimental sessions will be repeated three times per week, will be realized 10 sessions. At home the patient will spend 6 hours per day with the restraint for the paretic upper limb.

Other: tDCS

Physiotherapy + cathodal tDCS + mCIMT

EXPERIMENTAL

Before a cathodal tDCS with duration of 9 minutes and intensity of 1mA applied at the healthy motor cortex, the patient will be submitted to a 30 minutes physiotherapy protocol. Lastly the individual will realized a 45 minutes mCIMT protocol. The experimental sessions will be repeated three times per week, will be realized 10 sessions. At home the patient will spend 6 hours per day with the restraint for the paretic upper limb.

Other: tDCS

Physiotherapy+bi-hemispheric tDCS+mCIMT

EXPERIMENTAL

Before a bi-hemispheric tDCS with duration of 13 minutes and intensity of 1mA applied at the healthy (cathode) and injured (anode) motor cortex, the patient will be submitted to a 30 minutes physiotherapy protocol. Lastly the individual will realized a 45 minutes mCIMT protocol. The experimental sessions will be repeated three times per week, will be realized 10 sessions. At home the patient will spend 6 hours per day with the restraint for the paretic upper limb.

Other: tDCS

Physiotherapy+sham tDCS+mCIMT

SHAM COMPARATOR

Before a sham tDCS with duration of 30 seconds and intensity of 1mA applied at the injured motor cortex, the patient will be submitted to a 30 minutes physiotherapy protocol. Lastly the individual will realized a 45 minutes mCIMT protocol. The experimental sessions will be repeated three times per week, will be realized 10 sessions. At home the patient will spend 6 hours per day with the restraint for the paretic upper limb.

Other: tDCS

Physiotherapy+tDCS+mental practice

EXPERIMENTAL

Before a tDCS protocol applied during de mental practice training , the patient will be submitted to a 30 minutes physiotherapy protocol. The experimental sessions will be repeated three times per week, will be realized 10 sessions.

Other: tDCS

Physiotherapy+sham tDCS+mental practice

SHAM COMPARATOR

Before a sham tDCS protocol applied during the mental practice training, the patient will be submitted to a 30 minutes physiotherapy protocol. The experimental sessions will be repeated three times per week, will be realized 10 sessions.

Other: tDCS

Physiotherapy

NO INTERVENTION

The patient will be submitted to a 30 minutes physiotherapy protocol. The experimental sessions will be repeated three times per week, will be realized 10 sessions.

Interventions

tDCS OTHER

tDCS involves application of very low-amplitude direct currents(2 mA or less) via surface scalp electrodes.This produces a sub-sensory level of electrical stimulation which remains imperceptible by most people during its application. In a small percentage of patients it may cause minimal discomfort with a mild tingling sensation, which usually disappears after a few seconds. The applied current modifies the transmembrane neuronal potential and thus influences the level of excitability. Depending on the polarity of active electrodes tDCS can increase or decrease corticomotor excitability. Cathodal tDCS decrease and anodal tDCS increase the motor cortex excitability.

Also known as: non invasive brain stimulation

Physiotherapy + cathodal tDCS + mCIMT; Physiotherapy+bi-hemispheric tDCS+mCIMT; Physiotherapy+sham tDCS+mCIMT; Physiotherapy+sham tDCS+mental practice; Physiotherapy+tDCS+mental practice; physiotherapy + anodal tDCS + mCIMT

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• chronic stroke (\> 6 months)
• score ≥ 20 at the Folstein Mini Mental State Examination
• score ≤ 3 at the Ashworth Scale
• score ≤ 4 at the Visual Analog Pain Scale

You may not qualify if:

• multiple brain lesions
• medication for treatment of spasticity
• attention deficit
• deficit in perceptual ability and motivation to follow the instructions for the mental training
• pregnant
• pacemaker
• metal implant in the region of the skull and face
• history of convulsion
• epilepsy

Sponsors & Collaborators

• Universidade Federal de Pernambuco: lead

Study Sites (1)

Applied Neuroscience Laboratory

Recife, Pernambuco, 50740-560, Brazil

Location

MeSH Terms

Conditions

Stroke

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Study Officials

• Kátia K Monte Silva, PhD

  Universidade Federal de Pernambuco

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD in Neuroscience

Study Record Dates

• First Submitted: May 10, 2013
• First Posted: June 18, 2013
• Study Start: January 1, 2011
• Primary Completion: August 1, 2013
• Study Completion: December 1, 2014
• Last Updated: April 13, 2015

Record last verified: 2014-05

Locations

BR (1)