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StrokePhase 2NCT01879787

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

A Phase 2 study testing tDCS in people with Stroke, run by Universidade Federal de Pernambuco at 1 site in Brazil.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 40 to 80 years
Conditions the study is for
Stroke
What is being tested?
tDCS
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
84 participants
Where
1 siteBrazil
Study dates
Jan 2011to Dec 2014
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 9Show fewer
  • metal implant in the region of the skull and face
  • history of convulsion
  • epilepsy

Trial locations and contacts

1 site in 1 country.

Brazil1 site
  • Applied Neuroscience Laboratory

    Recife, Pernambuco, 50740-560

Other trials in Brazil

About this study

Official title: Impact of Transcranial Direct Current Stimulation (tDCS)on the Effects of Mental Practice and Modified Constraint-induced Movement Therapy (mCIMT)in the Rehabilitation of Chronic Stroke Patients

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

Read the detailed description

Eighty-four patients chronic post-stroke will be recruited to participate in the study. After screening to check the eligibility criteria and giving informed consent, the patients will be randomized into seven distinct groups (12 per group). All the patients will be submitted to 12 therapeutic sessions that will occur with a frequency of three times a week.

Before, immediately after and 1 month after the beginning of the experimental sessions patients will be submitted to an evaluation at each moment will be applied: (i) Fugl- Meyer Scale, (ii) Motor Activity Log Scale, (iii ) Jebsen-Taylor hand functional test, (iv) Independence Functional Measure (v) Box-Block Test, (vi) Dynamometry and (vii) Berg Balance Scale.

In experimental sessions, the subjects always receive physiotherapy treatment with conventional techniques, the protocol will follow the guidelines outlined in Clinical Practice Guideline for physical therapy in stroke patients with the Royal Dutch Society for Physical Therapy (2004). Besides physical therapy, the patient may be subjected to transcranial direct current stimulation (tDCS) associated with the techniques of modified constraint-induced movement therapy (mCIMT) or mental practice (MP).

tDCS protocol During tDCS sessions, the patients will be seated in a comfortable chair with head and arm rests. Continuous direct current will be applied by clinical microcurrent stimulator (Soterix, USA) using a pair of saline-soaked surface sponge electrodes (surface 35 cm2). For anodal and sham stimulation (the polarity refers always to the motor cortical electrode), the anode electrode will be placed over primary motor cortex (M1; EEG 10/20 system) of the affected hemisphere and cathode above contralateral orbit. For cathodal tDCS, the cathode will be positioned over M1 of the non-affected hemisphere and the anode was placed above the contralateral orbit. For bi-hemispheric tDCS the anode electrode will be placed over M1 of the affected hemisphere and the cathode over the M1 of the healthy hemisphere. Transcranial direct current stimulation will be administered with a current strength of 1 mA for 13 (anodal/bi-hemispheric tDCS) or 9 min (cathodal tDCS). Sham tDCS will be performed by current flow for 30 s, a method shown to achieve a good level of blinding mCIMT protocol The modified CIMT consisted of (i) complete immobilization of the non-paretic upper limb and (ii) intensive training the paretic upper limb and will be administered by a trained therapist, who was not involved in the pre-post evaluations.

Continuously for six hours daily over a period of four weeks, including weekend, all patients will be remained with complete immobilization of the non paretic upper limb. For this, an arm sling with the shoulder in adduction and internal rotation, elbow flexed at 90º, wrist and fingers in neutral position, made specifically for each patient will be used. They will be advised to use the restriction during their daily activities and instructed to remove it every hour for 10 minutes to perform stretching, which has been previously taught by the researchers to avoid functional deterioration caused by disuse. All muscle groups of the upper extremity will be stretched. A guide with instructions of the stretching will be distributed to patients. The patients will be instructed to take the immobilization on every day at same hour the tDCS sessions. In addition, the patients will be allowed to take the arm sling off during activities in which safety would be compromised, such as toileting, dressing, and bathing.

For intensive training the paretic upper limb, the patients will attend a gross motor and fine motor activities program performed for 1 hour per day, three times per week. Each task was performed for 2-3 minutes and the rest interval between tasks will be determined for each subject in order to avoid fatigue and excessive tiredness. The tasks will be progressively adapted by increasing speed or accuracy to allow improvement of patient performance. All tasks will be done with subjects sitting on a chair with standard dimensions and performed on support table. During training sessions, the patients will remain with the non-paretic arm immobilized.

Mental practice protocol Prior to experimental sessions, the mental capacity of subjects to learn the imagery techniques will be tested by the Kinesthetic and Visual Imagery Questionnaire and a chronometric test. The Kinesthetic and Visual Imagery Questionnaire is an imagery assessment tool comprised of 10 items, each scored on a five-point ordinal scale, including the image clarity (visual dimension) and the sensations intensity (kinesthetic dimension) of body movements. Each item describes an action: (i) neck flexion/extension, (ii) shoulder shrugging, (iii) forward trunk flexion, (iv) forward shoulder flexion, (v) elbow flexion, (vi) thumb to finger tips, (vii) knee extension, (viii) hip abduction, (ix) foot external rotation, and (x) foot tapping. Subjects physically execute each movement and immediately afterwards imagine performing the same movement. A score of 5 corresponds to the highest clarity/intensity, and a score of 1 corresponds to the lowest clarity/ intensity (for a review, see Malouin et al., 2007). The Kinesthetic and Visual Imagery Questionnaire scores allowed the researcher to assess each participant's abilities and decide whether the subject was a suitable candidate for MP. Comparing actual and imagined movement times, the chronometric test determined the motor imagery ability of participants.

The mental practice will consist of motor imagination of tasks. These tasks will consist of action for the patient to imagine themselves, with the greatest wealth of detail possible, performing motor activities with the hemiparetic upper limb, such as the movement of the touching thumb on each other's toes hand, or even the movement of bringing a cup towards his mouth. The technique of mental practice will be applied at the same time of the tDCS.

Conditions
Stroke
Being tested
tDCS
Keywords
Stroke, transcranial direct current stimulation, constraint-induced movement therapy, mental practice
Medical subject headings
Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • tDCSOther

    Also called non invasive brain stimulation

    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.

Study groups in NCT01879787
Study groupRoleWhat they receive
physiotherapy + anodal tDCS + mCIMTExperimentalBefore 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.
Receives: Other: tDCS
Physiotherapy + cathodal tDCS + mCIMTExperimentalBefore 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.
Receives: Other: tDCS
Physiotherapy+bi-hemispheric tDCS+mCIMTExperimentalBefore 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.
Receives: Other: tDCS
Physiotherapy+sham tDCS+mCIMTSham comparatorBefore 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.
Receives: Other: tDCS
Physiotherapy+tDCS+mental practiceExperimentalBefore 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.
Receives: Other: tDCS
Physiotherapy+sham tDCS+mental practiceSham comparatorBefore 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.
Receives: Other: tDCS
PhysiotherapyNo interventionThe 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: At baseline, 1 month and 2 month

Secondary outcomes (1)
  1. Change from Motor Activity Log

    The MAL is a scripted, structured interview to measure real-world upper extremity function. It was developed to measure the effects of therapy on the more impaired arm following stroke. The original MAL consists of 14 activities of daily living (ADLs) such as using a towel, brushing teeth, and picking up a glass. For a specified time period post-stroke, the individual is asked about the extent of the activity performed and how well it was performed by the more impaired arm. The response scale ranges from 0 (never used) to 5 (same as pre-stroke). The mean of the scores for frequency of the activity comprises the Amount of Use (AOU) scale; the mean of the scores for how well the activity was performed comprises the Quality of Movement (QOM) scale. Ideally, ratings are obtained from the individual with a stroke as well as a knowledgeable informant (caregiver).

    Measured: At baseline, 1 month and 2 month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Jun 2013 (estimated)
  2. Study startJan 2011
  3. Primary completionAug 2013
  4. Study completionDec 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
84 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01879787
Sponsor's protocol ID
tDCS_mCIMT_MP_Stroke
Status last verified
May 2014
First submitted
10 May 2013
Last updated
13 Apr 2015
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing tDCS in people with Stroke, run by Universidade Federal de Pernambuco at 1 site in Brazil.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from Fugl-Meyer Assessment of Upper Extremity Motor Function (time frame: At baseline, 1 month and 2 month). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2015.

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