NCT02860403

Brief Summary

Single center, pilot study, to evaluate the influence of Motor Imagery (MI) on functional rehabilitation and cerebral plasticity through the qualitative and quantitative mental practice approach. For this, the investigators will use magnetoencephalography (MEG) but also physiological and behavioral indicators developed by the Laboratoire de la Performance Motrice, Mentale et du Matériel (P3M) of Université Claude Bernard Lyon 1 and its partners.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2013

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2013

Completed
28 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2013

Completed
3.4 years until next milestone

First Submitted

Initial submission to the registry

August 4, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 9, 2016

Completed
Last Updated

May 28, 2019

Status Verified

August 1, 2016

Enrollment Period

28 days

First QC Date

August 4, 2016

Last Update Submit

May 23, 2019

Conditions

Tetraplegia C5-C6Tetraplegia C6-C7

Keywords

Cervical spinal cord injuryMotor imageryMagnetoencephalography

Outcome Measures

Primary Outcomes (1)

  • Motor imagery ability

    Motor imagery ability assessed by magnetoencephalography measurements

    10 weeks

Secondary Outcomes (15)

  • Movement time (MT)

    10 weeks

  • absolute time to peak velocity

    10 weeks

  • movement amplitude at peak velocity

    10 weeks

  • time to opening

    10 weeks

  • time to maximal opening

    10 weeks

  • +10 more secondary outcomes

Study Arms (3)

C6-C7 patients

EXPERIMENTAL

C6-C7 patients able to recover tenodesis grasp.

Procedure: motor imagery

C5-C6 patients

EXPERIMENTAL

C5-C6 patients for whom surgery for rehabilitation of an upper limb is indicated with a upper limit of one year after trauma, and after complete clinical and functional evaluation

Procedure: motor imagery

Control group

NO INTERVENTION

a control group (n=6) matched on age and sex to C6-C7 without medical history or neurological disorder

Interventions

motor imageryPROCEDURE

Intervention consisted of supervised MI during which the participants were trained to imagine performing a single-joint wrist extension movement and a multiple-joint reach-to-grasp movement using tenodesis. The two movements were practiced in separate blocks and each 45 minute MI session consisted of six to eight blocks. Within a given block patients; i) performed the movement once, ii) imagined it using visual imagery (between five and ten repetitions), iii) performed the movement again, and iv) imagined it using kinesthetic imagery (between five and ten repetitions). All movements (performed and imagined) were timed by the experimenter to ensure that the durations of both imagined and physically practiced movements were similar. Imagery vividness was controlled with self-rated assessments using a visual analogic scale (from 0, the image or feeling was absent, to 10 when it was as clear or intense as physical practice).

C5-C6 patientsC6-C7 patients

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • years old,
  • quadriplegia elicited by spinal cord injury (SCI) at the C5, C5-C6, C6, or C6-C7 level,
  • complete infra-lesional motor deficit according to the ASIA impairment scale with finger and forearm flexor muscles paralysis,
  • post-traumatic period \>6 months (since a motor recovery plateau is usually reached at 6-month post-SCI

You may not qualify if:

  • non-stabilized hypertension or pathological autonomic nervous system dysfunction (e.g., orthostatic hypotension),
  • cerebral damage and/or cognitive deficit,
  • elbow or shoulder joint amplitude restriction, upper limb para-osteoarthropathy,
  • participation to another study
  • presence of metallic objects within the body incompatible with MEG or functional magnetic resonance imaging (fMRI) recordings.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpital Henry Gabrielle - Médecine physique et Réadaptation, Hospices Civils de Lyon, 20 Route de Vourles,

Saint-Genis-Laval, 69230, France

Location

Related Publications (1)

  • Mateo S, Reilly KT, Collet C, Rode G. Descriptive pilot study of vividness and temporal equivalence during motor imagery training after quadriplegia. Ann Phys Rehabil Med. 2018 Sep;61(5):300-308. doi: 10.1016/j.rehab.2018.06.003. Epub 2018 Jun 23.

    PMID: 29944923RESULT

Study Officials

  • Gilles RODE, Pr

    Hospices Civils de Lyon

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 4, 2016

First Posted

August 9, 2016

Study Start

February 1, 2013

Primary Completion

March 1, 2013

Study Completion

March 1, 2013

Last Updated

May 28, 2019

Record last verified: 2016-08

Locations

FR(1)