Paired Associative Stimulation in Post-stroke Hand Motor Deficits

NCT02284087 | Completed

• 2 other identifiers: C14-382014-A01165-42
• Study Type: observational
• Target: 81
• Locations: 1 country
• Sites: 1

Brief Summary

Introduction The motor impairment of the upper extremity is the most common sequelae after ischemic stroke. Transcranial magnetic stimulation (TMS) is a promising non- invasive technique in the rehabilitation of motor deficits. However, its effect in post-stroke motor deficits remains moderate our days. To potentiate the effect of TMS, techniques called Paired Associative Stimulations (PAS) involving the integration of afferent sensory inputs at the level of the ipsilesional primary motor cortex were developed in healthy subjects. PAS techniques have shown a gain of corticospinal excitability by such phenomenon known as long Term Potentiation (LTP) and a gain of motor performance. The investigators would like to propose to evaluate two types of these techniques with a volley of visual afferents (visuomotor stimulation, V\_PAS) or of cerebellar afferents (CER\_PAS), because these two structures convey important information in the execution of the movement. Design Multicenter, randomized, study, 60 patients in 3 parallel groups (V\_PAS, CER\_PAS, control group with sham and sham V\_PAS CER\_PAS), 5 days of treatment, clinical assessment, electrophysiological and MRI before, immediately post- and second post-assessments (4 weeks). A group of 24 healthy subjects will undergo a parallel physiopathological study on the underlying mechanisms of cerebellar PAS Objectives Main objective: To determine whether (and how) Paired Associative Stimulation technique (PAS) induces cerebral reorganization in the primary motor cortex compared to the control group. Aim 2: Determine whether (and which) type of PAS is capable of inducing changes in motor performance of the upper limb paresis and duration Aim 3: Determine whether (and which) type of PAS is capable of inducing changes in excitability of the corticospinal tract and duration Aim 4: Determine how PAS techniques modify the functional connectivity during movement Aim 5: Determine if connectivity changes during induced movement correlate with clinical improvements Aim 6: Determine whether patients who benefit of a type of PAS have specific anatomical lesion characteristics (volume, afferent and efferent white matter fasciculi integrity)

Conditions

Stroke and Healthy Subjects

Keywords

transcranial magnetic stimulation; movement disorders

Outcome Measures

Primary Outcomes (1)

• change in lateralization indices in the primary motor cortex using functional magnetic Resonance

  Change from Baseline to day 5 (Pre and post intervention)

Secondary Outcomes (2)

• change in motor score of the affected hand by the Jebsen Taylor Test

  Change from Baseline to day 5 (Pre and post intervention)

• change in corticospinal excitability by the motor evoked potentials

  Change from Baseline to day 5 (Pre and post intervention)

Study Arms (4)

V_PAS

Visuomotor paired associative stimulation protocol

Device: PAS

Sham V_PAS

Placebo group of Visuomotor paired associative stimulation protocol

CER_PAS

cerebellar-motor associative stimulation protocol

Device: PAS

Sham CER_PAS

Placebo group of cerebellar-motor associative stimulation protocol

Interventions

PAS DEVICE

CER_PAS; V_PAS

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Stroke patients

You may qualify if:

• First event ischemic stroke with hand motor deficit
• Time since stroke \> 30 days
• Stroke lesion sparing the primary motor cortex (hand knob area)
• Age between 18 and 85 ans

You may not qualify if:

• No homonymous hemianopia
• No contra-indications for TMS and MRI
• Pregnancy
• Epilepsia
• Any pathology that threatened the 1 month follow up
• Age between 18 and 85
• Right handed
• No contra-indications for TMS and MRI
• Pregnancy
• Any cerebral pathology or pathology that threatened the 1 month follow up

Sponsors & Collaborators

• Institut National de la Santé Et de la Recherche Médicale, France: lead

Study Sites (1)

ICM, CIC Neurosciences

Paris, 75013, France

Location

Related Publications (4)

• Rosso C, Moulton EJ, Kemlin C, Leder S, Corvol JC, Mehdi S, Obadia MA, Obadia M, Yger M, Meseguer E, Perlbarg V, Valabregue R, Magno S, Lindberg P, Meunier S, Lamy JC. Cerebello-Motor Paired Associative Stimulation and Motor Recovery in Stroke: a Randomized, Sham-Controlled, Double-Blind Pilot Trial. Neurotherapeutics. 2022 Mar;19(2):491-500. doi: 10.1007/s13311-022-01205-y. Epub 2022 Feb 28.

  PMID: 35226342 RESULT

• Kemlin C, Moulton E, Leder S, Houot M, Meunier S, Rosso C, Lamy JC. Redundancy Among Parameters Describing the Input-Output Relation of Motor Evoked Potentials in Healthy Subjects and Stroke Patients. Front Neurol. 2019 May 21;10:535. doi: 10.3389/fneur.2019.00535. eCollection 2019.

  PMID: 31178817 RESULT

• Rosso C, Perlbarg V, Valabregue R, Obadia M, Kemlin-Mechin C, Moulton E, Leder S, Meunier S, Lamy JC. Anatomical and functional correlates of cortical motor threshold of the dominant hand. Brain Stimul. 2017 Sep-Oct;10(5):952-958. doi: 10.1016/j.brs.2017.05.005. Epub 2017 May 17.

  PMID: 28551318 RESULT

• Rosso C, Lamy JC. Does Resting Motor Threshold Predict Motor Hand Recovery After Stroke? Front Neurol. 2018 Nov 29;9:1020. doi: 10.3389/fneur.2018.01020. eCollection 2018.

  PMID: 30555404 RESULT

MeSH Terms

Conditions

Stroke; Movement Disorders

Condition Hierarchy (Ancestors)

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

Study Officials

• Charlotte ROSSO, PI

  Brain and Spine institute, INSERM UMR 1127, CNRS 7225

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 21, 2014
• First Posted: November 5, 2014
• Study Start: January 26, 2015
• Primary Completion: November 7, 2018
• Study Completion: November 7, 2018
• Last Updated: December 10, 2025

Record last verified: 2025-03

Locations

FR (1)