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Completed

NCT Number: NCT01500564

Functional Interest of Non Invasive Brain Stimulation During Physiotherapy at a Subacute Phase Post Stroke (Anodal Protocol): ReSTIM

Previous research that utilises single sessions of transcranial direct current stimulation (tDCS) have demonstrated functional improvements. However these improvements are usually short-lived, lasting less than one hour before the patient's performance returns to baseline. In these studies, tDCS is typically applied with the goal of adaptively enhancing functional activation of pathologically under-active tissue or suppressing pathologically over-active tissue. Interestingly, a small body of evidence is now emerging to indicate that tDCS can improve learning/memory functions in healthy controls. The goal of this study is to test if the application of tDCS could enhance learning and/or memory for physiotherapy rehabilitation, which may in turn lead to correspondingly greater motor improvement. Patients at a subacute stage (1 to 6 month post stroke) will attend for 10 consecutive daily sessions of tDCS.

This research has important implications; previous studies suggest that such an approach has the potential to facilitate physical rehabilitation post-stroke and establish tDCS as a clinically viable rehabilitative tool. Recovery of motor skills may take many months to acquire and therefore strategies that have the potential to enhance acquisition of skill are of practical and scientific interest.

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Key information

Conditions

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

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre de Lay-Saint-Christophe-Institut Régional de Médecine Physique et de Réadaptation, Lay-Saint-Christophe, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • All subjects must be between the ages of 18-90 and must not be pregnant.
  • Patients volunteer to participate in the study, with a written informed consent signed
  • Affiliation to a national health insurance program
  • First-time clinical ischemic or hemorrhagic cerebrovascular accident - evidenced by a radiological (or physician's) report
  • Contralesional motor deficit
  • Lesion sparing primary motor cortex
  • Stroke onset >1 month and <6 months prior to study enrollment

Exclusion criteria

  • Coexistent major neurological or psychiatric disease as to decrease number of confounders
  • History of epilepsy before stroke (or episodes of seizures within the last six months)
  • Any substantial decrease in alertness, language reception, or attention that might interfere with understanding instructions for motor testing
  • Subjects with global aphasia and deficits of comprehension
  • Excessive pain in any joint of the paretic extremity (VAS>4)
  • Contraindications to Tdcs : metal in the head, implanted brain medical devices
  • Coexistent major neurological or psychiatric disease as to decrease number of confounders
  • A history of significant alcohol or drug abuse in the prior 6 months
  • Anyone who is currently taking or who has taken anti-malarial treatment in the last 72 hours
  • Subjects may not have already received constraint induced motor therapy and/or tDCS treatment for stroke
  • Pregnancy

Treatment and study plan

anodal tDCS (device) Eldith DC-Stimulator

Device

tDCS applied to the motor cortex every day of two consecutive weeks (10 sessions) at 1 mA during 20 minutes. Conductive rubber covered by sponges soaked in saline will be used, held in place by a band. The current will be gradually increased over 100 seconds.

Other names: Eldith DC-Stimulator (CE certified)

Sham tDCS

Device

Participants will receive sham tDCS over the primary motor cortex of the ipsilesional hemisphere during 20 minutes of motor training (10 consecutive sessions Monday-Friday during two weeks).

Primary outcomes

  1. Fugl Meyer Assessment (Upper extremity) of motor recovery following stroke

    Time frame: assessed at one baseline session (day 4), and then again immediately following the last day of the intervention (day 18), 2 weeks (day 32), 1 month, 3 months and 6 months later.

    Main primary outcome is change in score between the baseline session score and day 32.

Secondary outcomes

  1. Functional independence scale (MIF)

    Time frame: assessed at one baseline session (day 4), and then again immediately following the last day of the intervention (day 18), 2 weeks (day 32), 1 month, 3 months and 6 months later.

    We are looking for a change in scores between the baseline session score, and those collected during each follow-up session.

  2. Motor Activity Log (MAL)

    Time frame: assessed at one baseline session (day 4), and then again immediately following the last day of the intervention (day 18), 2 weeks (day 32), 1 month, 3 months and 6 months later.

    We are looking for a change in scores between the baseline session score, and those collected during each follow-up session.

  3. Jebsen Taylor Hand function test (JTT)

    Time frame: assessed at one baseline session (day 4), and then again immediately following the last day of the intervention (day 18), 2 weeks (day 32), 1 month, 3 months and 6 months later.

    We are looking for a change in scores between the baseline session score, and those collected during each follow-up session.

  4. Box and block test (BBT)

    Time frame: assessed at one baseline session (day 4), and then again immediately following the last day of the intervention (day 18), 2 weeks (day 32), 1 month, 3 months and 6 months later.

    We are looking for a change in scores between the baseline session score, and those collected during each follow-up session.

  5. Modified Ashworth Scale

    Time frame: assessed at one baseline session (day 4), and then again immediately following the last day of the intervention (day 18), 2 weeks (day 32), 1 month, 3 months and 6 months later.

    We are looking for a change in scores between the baseline session score, and those collected during each follow-up session.

  6. Testing motor MRC

    Time frame: assessed at one baseline session (day 4), and then again immediately following the last day of the intervention (day 18), 2 weeks (day 32), 1 month, 3 months and 6 months later.

    We are looking for a change in scores between the baseline session score, and those collected during each follow-up session.

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Official study title

Functional Interest of Non Invasive Brain Stimulation During Physiotherapy at a Subacute Phase Post Stroke (Anodal Protocol).

Acronym: ReSTIM

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Dec 28, 2011
Registry last updated
Jan 31, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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