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StrokeMIPASNCT02779218

Combination of Motor Imagery Exercises and Brain Stimulation TMS Type PAS in Patients After Hemiplegic Stroke

A study testing Paired Associative Stimulation and Paired Associative Stimulation + Motor Imagery exercises in people with Stroke, run by University Hospital, Toulouse at 1 site in France.

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

Strokes represent, in industrialized countries the leading cause of acquired motor disability in adults older than 40. Stroke is responsible for France from 150 000 to 200 000 new cases of hemiplegia each year. These patients will see their deficit to improve during the first 6 months after stroke. Read more about this study

Who is it for?
Ages 18 to 85 years
Conditions the study is for
Stroke
What is being tested?
Paired Associative Stimulation and Paired Associative Stimulation + Motor Imagery exercises
Type of treatment
Surgery or procedure
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
24 participants
Where
1 siteFrance
Study dates
Jan 2013to Feb 2018
Phase
Interventional
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 18 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 18-85 years
  • Patients who have experienced a Stroke of more than one month
  • Deficit out of the upper limb (Fugl Meyer member sup <50/66)
  • Presence of ECR muscle MEP
  • Able to carry the motor imagery according to a test by measuring chronometer
  • Patient who signed informed consent
  • Subject affiliated to the social security system

Who cannot join

  • history of epilepsy or seizure
  • MEP Lack of ECR
  • Presence of a cons-indication for use of magnetic stimulation or MRI:
  • Surgical Clips, metal sutures, staples, stent
  • Osteosynthesis devices on the head or neck
  • Pacemaker
Show all 15Show fewer
  • Implanted hearing aid
  • Ocular foreign body, shrapnel, bullets
  • Metal Worker
  • Heart Valve, endovascular equipment
  • Ventricular bypass valve
  • Pace-maker or neurostimulator
  • Claustrophobia
  • incapable adult Patient, safeguard justice, guardianship or trusteeship
  • Pregnant women and / or breastfeeding (because lack of data in the literature regarding the absence of foetotoxic effect)

Trial locations and contacts

1 site in 1 country.

France1 site

  • CHU Rangueil

    Toulouse

Other trials in France

About this study

Official title: Study of the Effects of the Combination of Motor Imagery Exercises and Transcranial Magnetic Stimulation (TMS) Type PAS in Patients After Hemiplegic Stroke

Strokes represent, in industrialized countries the leading cause of acquired motor disability in adults older than 40. Stroke is responsible for France from 150 000 to 200 000 new cases of hemiplegia each year. These patients will see their deficit to improve during the first 6 months after stroke. This recovery is largely based on brain plasticity mechanisms and the rehabilitation has as main objective to optimize these mechanisms. However, only 20% of patients hospitalized in a rehabilitation sector recover a functional upper limb. This lack of functionality is not only due to overall strength gap but also to the predominance of this gap on the extension movements of the wrist and fingers.

Meanwhile, work on brain plasticity helped develop new techniques of non-invasive brain stimulation (Non-invasive Brain Stimulation, NIBS) as the model of coupled stimulations (Paired Associative Stimulation, PAS) for modulating way over effective brain plasticity. In previous studies, the investigators have shown over a 30 minutes session lasting facilitation (60mn) and specific motor evoked potential (MEP) of the Extensor Carpi Radialis (ECR). Several studies showed an adjuvant effect when GSIN were associated with learning of a motor task. For PAS, some studies have shown a greater facilitation when the latter is associated with muscle contraction.

The motor imagery (MI) is imagining a movement without realizing it, it is based on mechanisms similar to those of the real movement. This technique also showed its effects as an adjuvant therapy in hemiplegic patients, however, they remain lower than those obtained after a motor drive. Its use in patients with no motor makes its uniqueness and strength.

Conditions
Stroke
Being tested
Paired Associative Stimulation, Paired Associative Stimulation + Motor Imagery exercises, Placebo Paired Associative Stimulation + Motor Imagery exercises
Keywords
Hemiplegia
Medical subject headings
Stroke, Hemiplegia

What participants receive

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

  • Paired Associative StimulationProcedure or surgery

    Patient with Paired Associative Stimulation only

  • Paired Associative Stimulation + Motor Imagery exercisesProcedure or surgery

    Patient with Paired Associative Stimulation + Motor Imagery exercises

  • Placebo Paired Associative Stimulation + Motor Imagery exercisesProcedure or surgery

    Patient with placebo Paired Associative Stimulation + Motor Imagery exercises

Study groups in NCT02779218
Study groupRoleWhat they receive
Sequence 1ExperimentalThe patients will receive in order : 1. Paired Associative Stimulation 2. Paired Associative Stimulation + Motor Imagery exercises 3. Placebo Paired Associative Stimulation + Motor Imagery exercises
Receives: Procedure: Paired Associative Stimulation; Procedure: Paired Associative Stimulation + Motor Imagery exercises; Procedure: Placebo Paired Associative Stimulation + Motor Imagery exercises
Sequence 2ExperimentalThe patients will receive in order : 1. Paired Associative Stimulation + Motor Imagery exercises 2. Placebo Paired Associative Stimulation + Motor Imagery exercises 3. Paired Associative Stimulation
Receives: Procedure: Paired Associative Stimulation; Procedure: Paired Associative Stimulation + Motor Imagery exercises; Procedure: Placebo Paired Associative Stimulation + Motor Imagery exercises
Sequence 3ExperimentalThe patients will receive in order : 1. Placebo Paired Associative Stimulation + Motor Imagery exercises 2. Paired Associative Stimulation 3. Paired Associative Stimulation + Motor Imagery exercises
Receives: Procedure: Paired Associative Stimulation; Procedure: Paired Associative Stimulation + Motor Imagery exercises; Procedure: Placebo Paired Associative Stimulation + Motor Imagery exercises

What is being measured

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

  1. Effect of a reeducation session as assessed by amplitude of motor evoked potential

    At the inclusion visit 25 minutes after stimulation

    Measured: Day 1

  2. Effect of a reeducation session as assessed by amplitude of motor evoked potential

    25 minutes after stimulation

    Measured: Week 1

  3. Effect of a reeducation session as assessed by amplitude of motor evoked potential

    25 minutes after stimulation

    Measured: Week 2

  4. Effect of a reeducation session as assessed by amplitude of motor evoked potential

    25 minutes after stimulation

    Measured: Week 3

Secondary outcomes (12)

  1. Resting Motor Threshold as assessed by minimal intensity to evoke a motor evoked potential

    After the first stimulation

    Measured: Week 1

  2. Resting Motor Threshold as assessed by minimal intensity to evoke a motor evoked potential

    After the second stimulation

    Measured: Week 2

  3. Resting Motor Threshold as assessed by minimal intensity to evoke a motor evoked potential

    After the third stimulation

    Measured: Week 3

  4. Active Motor Threshold as assessed by minimal intensity to evoke a motor evoked potential

    After the first stimulation

    Measured: Week 1

  5. Active Motor Threshold as assessed by minimal intensity to evoke a motor evoked potential

    After the second stimulation

    Measured: Week 2

  6. Active Motor Threshold as assessed by minimal intensity to evoke a motor evoked potential

    After the third stimulation

    Measured: Week 3

  7. Intensity curve as assessed by variation of intensity of motor evoked potential

    After the first stimulation

    Measured: Week 1

  8. Intensity curve as assessed by variation of intensity of motor evoked potential

    After the second stimulation

    Measured: Week 2

  9. Intensity curve as assessed by variation of intensity of motor evoked potential

    After the third stimulation

    Measured: Week 3

  10. Motricity of upper limb recovering as assessed by Fugl Meyer Score

    After inclusion visit

    Measured: Day 1

  11. Motricity of upper limb recovering as assessed by Fugl Meyer Score

    After the third stimulation

    Measured: Week 3

  12. Asymmetry index as assessed by resonance magnetic imaging

    At the inclusion visit

    Measured: Day 1

Timeline

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

  1. First posted20 May 2016 (estimated)
  2. Study startJan 2013
  3. Primary completionFeb 2018
  4. Study completionFeb 2018

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 N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Crossover
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
24 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02779218
Sponsor's protocol ID
12 389 02
Acronym
MIPAS
Status last verified
Jul 2020
First submitted
11 Jan 2016
Last updated
8 Apr 2026
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • Brihmat, N.; Castel-Lacanal, E.; Tarri, M.; Lepage, B.; Montane, E.; Cormier, C.; de Boissezon, X.; Gasq, D.; Loubinoux, I.; Marque, P. Motor Imagery and Paired Associative Stimulation in Poststroke Rehabilitation: Dissociating Motor and Electrophysiological Effects. Appl. Sci. 2023, 13, 6063

  • Brihmat N, Tarri M, Gasq D, Marque P, Castel-Lacanal E, Loubinoux I. Cross-Modal Functional Connectivity of the Premotor Cortex Reflects Residual Motor Output After Stroke. Brain Connect. 2020 Jun;10(5):236-249. doi: 10.1089/brain.2020.0750. Epub 2020 Jun 11.

    PubMed 32414294

Questions about this trial

What is this clinical trial studying?

A study testing Paired Associative Stimulation and Paired Associative Stimulation + Motor Imagery exercises in people with Stroke, run by University Hospital, Toulouse at 1 site in France.

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 15 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 8 Apr 2026. 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 France. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

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?

Effect of a reeducation session as assessed by amplitude of motor evoked potential (time frame: Day 1). The study lists 4 primary outcomes in all. 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 NCT02779218, which also lists 2 linked publications.

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 8 Apr 2026.

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