HemiparesisPhase 2NCT03008720

Evaluation of Electrical Activity Tibial Muscle and Postural Control of Individuals With Hemiparesia Post TDCS Associated With FES

A Phase 2 study testing Transcranial direct current stimulation (tDCS) and Functional electrical stimulation (FES) in people with Hemiparesis and Transcranial Direct Current Stimulation, run by University of Nove de Julho.

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 The sponsor has not verified this record for over two years, so it may be out of date.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

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Trial summary

Who is it for?: Ages 6 months and older
Conditions the study is for: Hemiparesis, Transcranial Direct Current Stimulation, Electromyography
What is being tested?: Transcranial direct current stimulation (tDCS) and Functional electrical stimulation (FES)
Type of treatment: Medical device
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 2 participants
Where: No sites listed yet
Study dates: Feb 2017to Nov 2018
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 6 months and older
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

Individuals with hemiparesis due to stroke;
Both sexes;
Agree to sign the free and informed consent form.

Who cannot join

Positive cut-off point for the Mini Mental State Examination (MMSE) of less than 11 points already corrected for schooling;
Ankle mobility reduced by history of fracture or use of ankle fasteners;
Irreducible equine deformity;
Muscle strength level of AT less than 1 by the scale of Kendall;
Patients with reported severe visual impairment;
Contraindications to the use of transcranial direct current stimulation (history of seizure or recurrent epilepsy, brain tumors at the stimulation site, metallic materials implanted in the brain);

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Individuals with cutaneous infection at the point of application of FECC or FES;
Individuals who presented anesthesia or hyperesthesia at the point of application of the ECTS;
Individuals diagnosed with deep venous thrombosis (DVT);
Individuals diagnosed with degenerative diseases or polyneuropathies.
Individuals who do not present complementary tests that diagnose the lesion site.

About this study

Official title: EVALUATION OF ELECTRICAL ACTIVITY TIBIAL MUSCLE AND POSTURAL CONTROL OF INDIVIDUALS WITH HEMIPARESIA FROM AVE SUBMITTED TDCS ASSOCIATED WITH FES - CLINICAL STUDY, RANDOMIZED, DOUBLE BLIND.

Introduction: It is suggested that increased cortical activity, induced by cerebral stimulation associated or not with other rehabilitation techniques, may potentiate the motor and functional therapeutic effects in individuals with neurological deficits. Objectives: To evaluate the electrical activity of the anterior tibial muscle (TA) and postural control of individuals with hemiparesis due to stroke following treatment with transcranial direct current (tDCS) stimulation and functional electrical stimulation (FES), associated or isolated). (EMG) and postural control by the Balance Evaluation Systems Test (BESTest). Both of which were collected at four different time points: pre-treatment, immediately after 10 treatment sessions, and 30 days follow-up after the interventions. Patients will be randomized into 4 experimental groups: tDCS anodic active + active FES+ active contraction TA, tDCS sham + active FES+ active contraction TA, tDCS anodic active+ placebo FES+ active contraction TA, tDCS sham+ FES sham+ active contraction TA. tDCS (2mA) will be applied over the motor (Cz) and cathodic vertex over the supraorbital region of the normal hemisphere and FES over hemiparetic TA by a researcher who will not be the one who will evaluate the anesthesia patient. The treatment will last 10 sessions, twice a week, with a time of 20 minutes.

Conditions: Hemiparesis, Transcranial Direct Current Stimulation, Electromyography
Being tested: Transcranial direct current stimulation (tDCS), Functional electrical stimulation (FES), Sham stimulation
Keywords: functional electrical simulation
Medical subject headings: Paresis

What participants receive

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

Transcranial direct current stimulation (tDCS)Device
Functional electrical stimulation (FES)Device
Sham stimulationDevice

Study groups in NCT03008720
Study group	Role	What they receive
tDCS active	Active comparator	Transcranial stimulation ( tDCS ) active will be administered using Tct Research 1 CH tdcs Simulator model 101. tDCS will be performed for 20 minutes and intensity 2mA associated active contraction of the TA muscle. Receives: Device: Transcranial direct current stimulation (tDCS)
tDCS sham	Placebo comparator	Placebo tDCS will follow the same procedures as active tDCS with active, but the tDCS device will only be switched on for 20 seconds. Receives: Device: Sham stimulation
FES active	Active comparator	Functional electrical stimulation (FES) active will be administered using QUARK® FES VIF 995 DUAL device. The duration of active FES will be 20 minutes, associated with active contraction of the TA muscle. The pulse width will be 250 μs, modulated at a frequency of 50 Hz, with one to two stimulation cycles (6 seconds on and 12 seconds off) and the intensity will be increased until reaching the motor threshold. Receives: Device: Functional electrical stimulation (FES)
FES sham	Placebo comparator	Placebo FES will follow the same procedures as active FES , but the FES device will only be switched on for 20 seconds, following which the intensity will be gradually reduced to 0 mA. Receives: Device: Sham stimulation

What is being measured

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

electrical activity (median frequency and amplitude of the electromyographic signal) of the anterior tibial muscle
Measured: 1 YEAR

Timeline

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

Feb 2017Nov 2018

First posted2 Jan 2017 (estimated)
Study startFeb 2017
Primary completionNov 2017 (estimated)
Study completionNov 2018 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for HemiparesisStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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, Outcomes assessor
Enrolment: 2 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03008720
Sponsor's protocol ID: 767.866
Status last verified: Jan 2017
First submitted: 28 Dec 2016
Last updated: 4 Jan 2017
Results posted: No
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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Evaluation of the Safety and Performance of the AWAKE Device in Patients With Hemiplegia or Hemiparesis Secondary to Stroke (ACV).
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All Hemiparesis trials

Study at a glance

From the registry record, last updated by the sponsor on 4 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: EVALUATION OF ELECTRICAL ACTIVITY TIBIAL MUSCLE AND POSTURAL CONTROL OF INDIVIDUALS WITH HEMIPARESIA FROM AVE SUBMITTED TDCS ASSOCIATED WITH FES - CLINICAL STUDY, RANDOMIZED, DOUBLE BLIND.
ClinicalTrials.gov ID: NCT03008720
Acronym / sponsor ID: 767.866
Conditions: Hemiparesis, Transcranial Direct Current Stimulation, Electromyography
Keywords: functional electrical simulation
Phase: Phase 2
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 2 participants (estimated)
Lead sponsor: University of Nove de JulhoUniversity, hospital or other
Study start: Feb 2017
Primary completion: Nov 2017 (estimated)
Study completion: Nov 2018 (estimated)
First posted: 2 Jan 2017 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, outcomes assessor)
Number of arms: 4

Arm	Type	Receives
tDCS active	Active comparator	Device: Transcranial direct current stimulation (tDCS)Transcranial stimulation ( tDCS ) active will be administered using Tct Research 1 CH tdcs Simulator model 101. tDCS will be performed for 20 minutes and intensity 2mA associated active contraction of the TA muscle.
tDCS sham	Placebo comparator	Device: Sham stimulationPlacebo tDCS will follow the same procedures as active tDCS with active, but the tDCS device will only be switched on for 20 seconds.
FES active	Active comparator	Device: Functional electrical stimulation (FES)Functional electrical stimulation (FES) active will be administered using QUARK® FES VIF 995 DUAL device. The duration of active FES will be 20 minutes, associated with active contraction of the TA muscle. The pulse width will be 250 μs, modulated at a frequency of 50 Hz, with one to two stimulation cycles (6 seconds on and 12 seconds off) and the intensity will be increased until reaching the motor threshold.
FES sham	Placebo comparator	Device: Sham stimulationPlacebo FES will follow the same procedures as active FES , but the FES device will only be switched on for 20 seconds, following which the intensity will be gradually reduced to 0 mA.

Who may qualify

Ages: 6 months and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (3 listed)

Individuals with hemiparesis due to stroke;
Both sexes;
Agree to sign the free and informed consent form.

Key exclusion criteria (11 listed)

Positive cut-off point for the Mini Mental State Examination (MMSE) of less than 11 points already corrected for schooling;
Ankle mobility reduced by history of fracture or use of ankle fasteners;
Irreducible equine deformity;
Muscle strength level of AT less than 1 by the scale of Kendall;
Patients with reported severe visual impairment;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Transcranial direct current stimulation (tDCS)	Device	tDCS active
Functional electrical stimulation (FES)	Device	FES active
Sham stimulation	Device	FES sham, tDCS sham

Primary outcome

electrical activity (median frequency and amplitude of the electromyographic signal) of the anterior tibial muscle
Time frame: 1 YEAR

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 Jan 2017.

Related trials for Hemiparesis

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Dynamic Stabilometry Combined With Transcranial Direct Current Stimulation for Balance and Motor Recovery After Ischemic Stroke
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Active, not recruiting
Stimulation Combined With Powered Motorized Orthoses for Walking After Stroke
Stroke, Hemiparesis
Recruiting
Telerehabilitation for Post-Stroke Hand Function
Stroke
RecruitingObservational study
Kinematic Analysis of Manual Dexterity
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Not yet recruiting
Evaluation of the Safety and Performance of the AWAKE Device in Patients With Hemiplegia or Hemiparesis Secondary to Stroke (ACV).
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

Questions about this trial

What is this clinical trial studying?

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 3 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 4 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.

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?

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?

electrical activity (median frequency and amplitude of the electromyographic signal) of the anterior tibial muscle (time frame: 1 YEAR). 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 NCT03008720.

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 4 Jan 2017.