AzTrials
AzTrials

StrokePhase 2NCT02166619

tDCS in Poststroke on Upper Limb Rehabilitation

A Phase 2 study testing tDCS + physical therapy in people with Stroke, run by Universidade Federal de Pernambuco at 3 sites in Brazil.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial summary

In this study, the investigators wondered whether bihemispheric transcranial direct current stimulation (tDCS) would be capable to potentialize the effects of physical therapy on upper limb rehabilitation of chronic stroke patients. 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 + physical therapy
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
24 participants
Where
3 sitesBrazil
Study dates
Dec 2013to Dec 2015
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

  • Primary or recurrent, ischemic or hemorrhagic stroke, confirmed by computed tomography or magnetic resonance imaging
  • Chronic Stroke (> 12 months)
  • Sensorimotor sequelae in an upper limb due to stroke
  • Score ≥ 18 at Folstein Mini Mental State Examination
  • Score ≥ 4 at Ashworth Scale
  • Minimal active wrist movement (flexion and extension)
  • At least one pinch movement

Who cannot join

  • Prior neurological diseases
  • Multiple brain lesions
  • Metal implant in the skull and face
  • Pacemaker
  • History of seizures
  • Epilepsy
Show all 11Show fewer
  • Pregnancy
  • Hemodynamic instability
  • Performing physical therapy elsewhere during the period of intervention
  • Score > 59 at the Fugl-Meyer Assessment of Motor Recovery after Stroke
  • Traumatic or orthopedic lesion limiting the range of motion of upper limb

Trial locations and contacts

3 sites in 1 country.

Kátia Monte-Silva, PhD contact

+55 81 88631322

monte.silvakk@gmail.com

Déborah Marques, PT contact

+55 81 97479444

deby.marques@gmail.com

Brazil3 sites, 3 recruiting
  • Applied Neuroscience Laboratory, Universidade Federal de Pernambuco

    Recife, Pernambuco, 50670-900

    Adriana Baltar, PT, +55 81 91296401, adrianabaltarmaciel@gmail.com

    Maíra Souza, PT, +55 81 89496886, mairasouza77@gmail.com

    Recruiting
  • D'Or Institute for Research and Education (ID'Or)

    Rio de Janeiro, Rio de Janeiro

    Fernanda Moll, PhD, fernandanrn@hotmail.com

    Fernanda Moll, PhD

    Recruiting
  • University Center Augusto Mota (UNISUAM)

    Rio de Janeiro, Rio de Janeiro

    Érika Rodrigues, PhD, +55 21 9971244796, erikacrodrigues@gmail.com

    Laura Oliveira, PhD, +55 21 934844107, lauraoliveira.ft@gmail.com

    Recruiting

Other trials in Brazil

About this study

Official title: Transcranial Direct Current Stimulation in Rehabilitation of Chronic Stroke Patients: Multicenter Clinical Trial

In this study, the investigators wondered whether bihemispheric transcranial direct current stimulation (tDCS) would be capable to potentialize the effects of physical therapy on upper limb rehabilitation of chronic stroke patients. Moreover, the study aims to investigate the pattern of physiological variables involved in the recovery of these patients. For this purpose, patients included will be submitted to 10 sessions with active or sham bihemispheric tDCS associated with intensive and individual physical therapy session.

Read the detailed description

Patients will undergo behavioral and electrophysiological evaluation before, immediately after, 30 and 90 days after 10 sessions (follow ups). They will be submitted to the following evaluations: (i) Fugl-Meyer Scale; (ii) Jebsen-Taylor hand functional test; (iii) Box-Block test; (iv) Motor Activity Log - 30; (v) Geriatric Depression Scale - 15; (vi) Beck Depression Inventory; (vii) Stroke Impact Scale; (viii) Hand Grip Strength and (iv) Modified Ashworth Scale. In addition, one question of motivation will be answered by patients in different stages of the treatment: (i) motivation regarding their own life at the beginning and ending of the treatment; (ii) daily motivation at the beginning of each session; (iii) motivation of the last week at the fifth and tenth sessions; (iv) motivation regarding their own life at 30 and 90 days after the ending of the treatment. A visual scale will be used to assess patient's motivation through five potential answers: "very little", "little", "more or less", "very much" and "extremely".

Electrophysiological measures will be performed before and after each session and in follow ups.

Evaluation of brain activity will be performed using single-pulse transcranial magnetic stimulation (TMS-p) only in Recife Centre. Magnetic stimulation (Neurosoft, Russia) will be applied through a figure-8 coil to determine motor cortex representation of first dorsal interosseus muscle (hotspot) and performed the following electrophysiological measures, in both cerebral hemispheres, to assess cortical activity: (i) Motor Evoked Potential (MEP); (ii) Active motor threshold (AMT) and (iii) Silent period (PS).

Evaluation of brain activity will be performed using single-pulse transcranial magnetic stimulation (TMS-p) only in Recife Centre. Magnetic stimulation (Neurosoft, Russia) will be applied through a figure-8 coil kept at a 45 degree angle relative to the sagittal line and pointed to the anterior region of the skull. Firstly, patients will be instructed to sit in a chair and to search a comfortable position. TMS-p will be applied in both motor cortex, healthy and injured, to determine the cortical representation of first dorsal interosseus muscle. The hotspot will be considered the most excitable area, with more intense motor evoked potential (MEP), measured by electromyography.

The following electrophysiological measures will be performed in both cerebral hemispheres to assess cortical activity:

(i) Motor Evoked Potential (MEP) : the intensity of magnetic stimulator is adjusted to produce an average MEP of 1.0 mV. TMS-p will be applied in the area of cortical representation of the first dorsal interosseous and mean responses to stimuli should reach 0.8 mV to 1.2 mV.

(ii) Active motor threshold (AMT) : will be request to the patient to perform contraction of the first interosseous muscle and then, will be given ten pulses by TMS-p to determinate active motor threshold. Motor threshold corresponds to the lowest intensity of TMS-p to produce a MEP of 50 μV in 50% of the pulses applied to the hotspot.

(iii) Silent period (PS) : is the interval of time that usually is observed absence of electromyographic activity. Occurs immediately after the registration of MEP during voluntary contraction of the target muscle (PEMvc - motor evoked potentials recorded during voluntary contraction). Higher the intensity of the magnetic stimulation, longer the duration of PS.

During tDCS application, patients will be seated in a comfortable chair with head and arms rests. Current will be applied by a DC stimulator (NeuroConn, Germany) using a pair of saline-soaked sponge electrodes (surface 24 cm²).

Bihemispheric tDCS will be applied to primary motor cortex (M1) in left and right hemispheres. These points correspond to C3 and C4 according to International 10-20 EEG system. Anode will be placed to M1 in affected hemisphere, while the cathode is positioned to M1 over the unaffected hemisphere. Parameters of current intensity and duration (dose) used were previously established in poststroke patients: 2 mA stimulation intensity for 20 minutes with current ramping up and down of 10 seconds each.

Sham tDCS has been used in several studies to evaluate the effect of active tDCS. In placebo stimulation, intensity and electrode's positions are the same as in the active group, however, current duration is only 30 seconds, with current ramping up and down of 10 seconds each. Moreover, the electrostimulation device is automatically turned off without patient's perception. Thus, patients experience early sensations (mild to moderate tingling) in stimulation site without inducing effect. Moreover, after each tDCS session, patients will answer adverse effects questionnaire.

After apply tDCS, 40 minutes of individual and intensive physical therapy session will be performed. Goals of the physical therapy protocol were discussed based in neuroplasticity principles by a group of experienced physiotherapists. Physical therapy activities will be focused on rehabilitation of upper limb and will cover the following purposes: flexibility, transfer and posture, coordination, balance and sensorial stimulation. Depending on patient's ability, a program of activities for each purpose will be adapted by a trained physical therapist.

The study will be conducted simultaneously in three research centers in Brazil: Applied Neuroscience Laboratory (LANA), Universidade Federal de Pernambuco (UFPE), Pernambuco, Brazil; D'Or Institute for Research and Education (ID'Or), Botafogo, Rio de Janeiro, Brazil and at the University Center Augusto Mota (UNISUAM), Bonsucesso Unit, Rio de Janeiro, Brazil.

Conditions
Stroke
Being tested
tDCS + physical therapy
Keywords
Stroke, Rehabilitation, Electric stimulation therapy, Neuroplasticity
Medical subject headings
Stroke

What participants receive

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

  • tDCS + physical therapyDevice

    Also called non invasive brain stimulation, neuroConn (Germany)

    Bihemispheric tDCS involves application of very low-amplitude direct currents (2 mA or less) via surface scalp electrodes. It produces a sub-sensory level of electrical stimulation wich remains imperceptible by most people during application. In a small percentage of patients, it may cause minimal discomfort with a mild tingling sensation, which usually disappears after a few seconds. Depending on the polarity, tDCS can increase or decrease corticomotor excitability. Anodal tDCS is able to facilitate neurons depolarization - increasing cortical excitability - while, on the other hand, cathodal tDCS hyperpolarizes the resting membrane potential, reducing the neuronal firing and the cortical excitability.

    Other: Physical Therapy

Study groups in NCT02166619
Study groupRoleWhat they receive
tDCS + physical therapyExperimentalFirstly, patients will undergo electrophysiological evaluation: motor evoked potential, motor threshold and silent period in both hemispheres. After those procedures, bihemispheric tDCS will be applied with duration of 20 minutes, intensity of 2 mA where anodal electrode will be on the affected hemisphere and the cathodal electrode, on the non-affected hemisphere. After tDCS, patients will be submitted to 40 minutes of physical therapy protocol. Experimental sessions will be repeated five times per week to complete 10 sessions.
Receives: Device: tDCS + physical therapy
Sham tDCS + physical therapySham comparatorFirstly, patients will undergo electrophysiological evaluation: motor evoked potential, motor threshold and silent period in both hemispheres. After those procedures, bihemispheric sham tDCS will be applied. Anodal electrode will be on the affected hemisphere and the cathodal electrode, on the non-affected hemisphere. Sham tDCS will be performed by ramping current flow for the first 10 seconds of stimulation, but switching the stimulator off after 30 seconds. After bihemispheric sham tDCS, patients will be submitted to 40 minutes of physical therapy protocol. Experimental sessions will be repeated five times per week to complete 10 sessions.
Receives: Device: tDCS + physical therapy

What is being measured

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

  1. Change in Fugl-Meyer assessment of paretic upper limb motor function

    Fugl-Meyer assessment is used to measure motor control recovery. It is a 226-point scoring system that includes the following sessions: range of motion, pain, sensation, motor function of upper and lower limbs, balance and coordination/velocity. We will apply only two sessions: upper limb motor function and coordination/velocity. These sessions totalize 66 points.The instrument provides a reliable and valid measure of specific motor function that is also sensitive to change.

    Measured: baseline, after sessions, 30 and 90 days

Secondary outcomes (1)
  1. Change from Motor Activity Log-30

    MAL is a scripted, structured interview to measure real-world upper extremity function. It was developed to measure the effects of therapy on the most impaired arm following stroke. Consists of 30 activities of daily living such as using a towel, brushing teeth and picking up a glass. For a specified time period post-stroke, patients are asked about the extent of activity performance and how well it was performed by the most impaired arm. Response scale ranges from 0 (never used) to 5 (same as pre-stroke). Scores average for activity frequency comprises the Amount of use scale (AOU); the mean of scores for how well the activity was performed comprises Quality of movement (QOM). Ideally, ratings are obtained from patient and as well as the caregiver.

    Measured: baseline, after sessions, 30 and 90 days

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 2014 (estimated)
  2. Study startDec 2013
  3. Primary completionDec 2014 (estimated)
  4. Study completionDec 2015 (estimated)

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
Double blind
Who is masked
Participant, Investigator
Enrolment
24 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02166619
Sponsor's protocol ID
ChronicStroke_tDCS_rehab
Status last verified
May 2014
First submitted
14 Jun 2014
Last updated
18 Jun 2014
Results posted
No
Data monitoring committee
Yes

Publications

  • Elsner B, Kugler J, Pohl M, Mehrholz J. Transcranial direct current stimulation (tDCS) for improving activities of daily living, and physical and cognitive functioning, in people after stroke. Cochrane Database Syst Rev. 2020 Nov 11;11(11):CD009645. doi: 10.1002/14651858.CD009645.pub4.

    PubMed 33175411

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing tDCS + physical therapy in people with Stroke, run by Universidade Federal de Pernambuco at 3 sites 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 7 inclusion and 11 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: status not confirmed, as of the sponsor's last update on 18 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites 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?

Results are not available in the source record.

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

Contact Kátia Monte-Silva, PhD (+55 81 88631322, monte.silvakk@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Fugl-Meyer assessment of paretic upper limb motor function (time frame: baseline, after sessions, 30 and 90 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02166619, which also lists 1 linked publication.

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 18 Jun 2014; AzTrials last refreshed its copy on 2 Nov 2026.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in