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Completed

NCT Number: NCT02525393

Transcranial Stimulation in Motor Stroke Rehabilitation

Patients were randomized in 3 groups: two intervent groups and a control group. The first group received two weeks of daily session of repetitive Transcranial Magnetic Stimulation (rTMS, 10 sessions) and, at least 6 months after, two weeks of daily transcranial Direct Current Stimulation (tDCS, 10 sessions); the second group received 10 daily session of tDCS and, after at least 6 months, 10 sessions of rTMS; the control group received 10 daily session of sham tDCS.

Physiatric evaluations (ARAT scale), neuropsychological assessment and ERP (P300) were performed before (1 week) and after (1 week) the end of each treatment. Furthermore, all patients underwent follow-up neuropsychological assessment 6 months after the end of each stimulation period and follow-up physiatric evaluation at 3 and 6 months after the end of each stimulation period.

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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–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

AOU Città della Salute e della Scienza

Turin, 10126, Italy

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • ischemic or hemorrhagic stroke (> 6 months from the accident)

Exclusion criteria

  • general cognitive impairment (Mini Mental State Examination < 25), severe functional disability (Barthel Index < 45),
  • psychiatric disorders,
  • degenerative neurological disorders,
  • epilepsy,
  • severe medical conditions,
  • having been implanted a drug infusion system, spinal/brain-stimulator, or endovascular coil

Treatment and study plan

tDCS

Device

Stroke rehabilitation performed with the aid of a transcranial electrical stimulation device.

Other names: HDC Stim device Newronica

rTMS

Device

Stroke rehabilitation performed with the aid of a repetitive transcranial magnetic stimulation device.

Other names: PowerMAG 100 MAG&More

SHAM

Device

Stroke sham stimulation performed with the aid of a transcranial electrical stimulation device.

Other names: HDC Stim device Newronica

Primary outcomes

  1. Change from the baseline ARAT (measures Grasp, Grip, Pinch, Gross Movement)

    Time frame: Baseline; 1 month; 3 months; 6 months; 6 months and 1 week; 7 months; 9 months; 12 months

    Action Research Arm Test (ARAT) measures Grasp, Grip, Pinch, Gross Movement. Baseline is 1 week before first treatment; other time frame: 1 week after first treatment; 3 months after first treatment; 6 months follow-up after first treatment; 1 week before second treatment; 1 week after second treatment; 3 months follow-up after second treatment; 6 months follow-up after second treatment.

Secondary outcomes

  1. P300 (latency)

    Time frame: Baseline; 1 month; 6 months and 1 week; 7 months

    The P300 (P3) wave is an event related potential (ERP) component elicited in the process of decision making.

    Investigators measured the latency of the component 1 week before first treatment; 1 week after first treatment; 1 week before second treatment; 1 week after second treatment.

  2. Cognition (standardized neuropsychological assessment)

    Time frame: Baseline; 1 month; 6 months; 6 months and 1 week; 7 months; 12 months

    The patients were evaluated by means of a standardized neuropsychological assessment consisting of a battery of cognitive tests involving the following domains: verbal short-term memory, visuospatial learning, working memory, verbal learning, attention and frontal executive functions, and general cognitive impairment.

    The assessment was repeated 1 week before first treatment; 1 week after first treatment; 6 months follow-up after first treatment; 1 week before second treatment; 1 week after second treatment; 6 months follow-up after second treatment.

Sponsors and collaborators

Lead sponsor

University of Turin, Italy

Other

Registry information

Official study title

Safety and Efficacy of Non Invasive Transcranial Brain Stimulation in Motor Stroke Rehabilitation

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Aug 17, 2015
Registry last updated
Aug 17, 2015

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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