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Health Condition(s) or Problem
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Stroke; Cerebral Infarction; Cerebrovascular Disorders; Brain Diseases
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Lay Summary
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This study aims to test whether repeated sessions of tDCS result in long-lasting
improvements in motor function in patients with chronic stroke.
(from ClinicalTrials.gov)
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Who can enter the trial
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Inclusion Criteria:
- Participant is willing and able to give informed consent for participation in the
study.
- Male or Female, aged 18 - 80 years.
- Patients should be at least six months post first symptomatic stroke affecting motor
function of the hand.
Exclusion Criteria:
- Anyone who does not have adequate understanding of verbal and written information in
English, sufficient to complete any of the safety screening forms.
- Anyone who has a previous history of epilepsy, febrile convulsions as a child or
recurrent fainting fits. Likewise, anyone who has a significant family history of
epilepsy would be excluded as all these conditions carry a theoretical risk of
increasing susceptibility to seizures.
- Any person who has a history of drug abuse or a previous history of a neurological or
psychiatric illness, or has a history of neurosurgical procedure is excluded as they
may be at increased risk of epilepsy and data collected may be influenced by their
condition.
- Patients on some prescription medications such as anti-depressants may be excluded as
they may be at an increased risk of seizures.
- Anyone who is currently taking or who has taken anti-malarial treatment in the last
72 hours.
- Pregnant women are excluded as a precaution as there is no data on the effect on
maternal cranial stimulation on the fetus.
- Any metallic implant in the neck, head, or eye and anyone with any implanted
electrical devices would be excluded as there is a risk of heating with both TMS and
TDCS stimulation.
- Anyone with any metal implants or implantable device would be excluded as indicated
by the MRI safety screening form. People who suffer with claustrophobia as they are
unable to tolerate the scanner.
- Patients who have had more than one stroke. Patients who have had a stroke will also
be excluded if they have limited communication in the form of aphasia or a history of
dementia.
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Who cannot enter the trial
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Inclusion Criteria:
- Participant is willing and able to give informed consent for participation in the
study.
- Male or Female, aged 18 - 80 years.
- Patients should be at least six months post first symptomatic stroke affecting motor
function of the hand.
Exclusion Criteria:
- Anyone who does not have adequate understanding of verbal and written information in
English, sufficient to complete any of the safety screening forms.
- Anyone who has a previous history of epilepsy, febrile convulsions as a child or
recurrent fainting fits. Likewise, anyone who has a significant family history of
epilepsy would be excluded as all these conditions carry a theoretical risk of
increasing susceptibility to seizures.
- Any person who has a history of drug abuse or a previous history of a neurological or
psychiatric illness, or has a history of neurosurgical procedure is excluded as they
may be at increased risk of epilepsy and data collected may be influenced by their
condition.
- Patients on some prescription medications such as anti-depressants may be excluded as
they may be at an increased risk of seizures.
- Anyone who is currently taking or who has taken anti-malarial treatment in the last
72 hours.
- Pregnant women are excluded as a precaution as there is no data on the effect on
maternal cranial stimulation on the fetus.
- Any metallic implant in the neck, head, or eye and anyone with any implanted
electrical devices would be excluded as there is a risk of heating with both TMS and
TDCS stimulation.
- Anyone with any metal implants or implantable device would be excluded as indicated
by the MRI safety screening form. People who suffer with claustrophobia as they are
unable to tolerate the scanner.
- Patients who have had more than one stroke. Patients who have had a stroke will also
be excluded if they have limited communication in the form of aphasia or a history of
dementia.
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What will happen
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Device; Anodal tDCS; Participants will receive anodal tDCS over the primary motor cortex of the ipsilesional hemisphere. The following parameters will be used: stimulation intensity of 1mA for the first 20 minutes of motor training (9 consecutive sessions Monday-Friday).; Anodal tDCS and Motor Training; Other; Motor Training; All participants will receive a standardised motor training intervention for the upper paretic limb; Anodal tDCS and Motor Training; Sham tDCS and Motor Training
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Primary aim
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Fugl Meyer Assessment of Motor Recovery following Stroke; Wolf Motor Function Test; Action Research Arm Test; 9 Hole Peg Test
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Secondary Aim
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Reaction Time Test; Assessed at 2 separate baseline sessions (at least 1 week apart), and then again immediately following the 9 day intervention (day 10), 1 week, 1 month and 3 months later.; No; We are looking for a change in scores between the average of the 2 baseline session scores, and those collected during each follow-up session.; Stroke Impact Scale; Assessed at 2 separate baseline sessions (at least 1 week apart), and then again immediately following the 9 day intervention (day 10), 1 week, 1 month and 3 months later.; No; We are looking for a change in scores between the average of the 2 baseline session scores, and those collected during each follow-up session.
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Participant Information Sheet
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Sorry, not currently available
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Website
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Sorry, not currently available
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Recruitment Status
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Recruiting
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Nation
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England
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Location
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Oxford
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