An interventional study of anodal tDCS and sham tDCS in Stroke and Apraxia, sponsored by University of Cologne. Completed at 2 sites in Germany. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2022-05-20.
Sponsored by University of Cologne · Not applicable, Interventional, and Treatment
The objective of the clinical trial is to investigate whether weak transcranial direct current stimulation (tDCS) can ameliorate the motor cognitive deficit apraxia during stroke rehabilitation. Stroke patients with apraxia will either receive a real stimulation or a sham stimulation (placebo) for 10 minutes at a time on 5 consecutive days during their in-patient stay in a rehabilitation center. Additionally, motor tasks are performed before and after the stimulation. The effect of the weak current stimulation on motor function is assessed 3-4 days after the last stimulation and 3 months after enrollment.
Despite the high incidence of the motor cognitive deficit apraxia after left-hemispheric stroke, evidence-based therapies do not exist. This randomized controlled clinical trial (RCT) investigates whether anodal transcranial direct current stimulation (tDCS) as an add-on therapy during neuro-rehabilitation can ameliorate apraxic deficits in patients with left hemisphere stroke. Therefore, anodal tDCS is applied over the parietal cortex of the left, lesioned hemisphere with an intensity of 2 mA for 10 minutes at a time on 5 consecutive days in combination with motor tasks before and after the stimulation. The effect of the stimulation is compared to a sham stimulation. Moreover, application of a pre-programmed study mode ensures a double-blind study design (patient and investigator). The performance in the apraxia test KAS (Cologne Apraxia Screening) 3-4 days after the last stimulation, compared to baseline, serves as primary endpoint of the study. Secondary endpoints are evaluated using various apraxia tests, motor tests and neuropsychological tests 3-4 days after the last stimulation and 3 months after enrollment.
8,255 studies on the registry are indexed under Stroke; 2,056 are open to participants now.
This study's enrollment of 117 is above the median of 49 across 6,024 interventional studies indexed under Stroke.
Browse Stroke studies →University of Cologne is the lead sponsor of 203 studies on the registry; 26 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Anodal tDCS at an intensity of 2 mA is applied for 10 minutes at a time on 5 consecutive days. The anodal electrode is placed over the left parietal cortex (P3 in 10/20 EEG) of the lesioned hemisphere, the cathodal electrode is located supraorbital on the right side. Motor tasks are performed before and after the stimulation.
Device: anodal tDCS
Sham stimulation is applied for 10 minutes at a time on 5 consecutive days. One electrode is placed over the left parietal cortex (P3 in 10/20 EEG) of the lesioned hemisphere and a second electrode supraorbital on the right side. Motor tasks are performed before and after the stimulation.
Device: sham tDCS
2 mA, 10 min, 5 sessions
Also known as: neuroConn DCS, model no. 008
sham stimulation, 10 min, 5 sessions
Also known as: neuroConn DCS, model no. 008
KAS (Cologne Apraxia Screening)
Degree of apraxia
Time frame: 3-4 days after stimulation
KAS (Cologne Apraxia Screening)
Degree of apraxia
Time frame: 3 months after enrollment
Goldenberg Imitation
Degree of apraxia
Time frame: 3-4 days after stimulation, and 3 months after enrollment
de Renzi Imitation
Degree of apraxia
Time frame: 3-4 days after stimulation, and 3 months after enrollment
de Renzi actual tool use
Degree of apraxia
Time frame: 3-4 days after stimulation, and 3 months after enrollment
Action Research Arm Test (ARAT)
Motor function
Time frame: 3-4 days after stimulation, and 3 months after enrollment
Jebsen Taylor Hand Function Test (JTHFT)
Motor function
Time frame: 3-4 days after stimulation, and 3 months after enrollment
Gripforce (Vigorimeter)
Motor function
Time frame: 3-4 days after stimulation, and 3 months after enrollment
Strength of hands (MRC)
Motor function
Time frame: 3-4 days after stimulation, and 3 months after enrollment
National Institute of Health Stroke Scale (NIHSS)
Impairment by stroke
Time frame: enrollment
modified Ranking Scale (mRS)
Impairment by stroke
Time frame: 3-4 days after stimulation, and 3 months after enrollment
Aphasia Check List (ACL-K)
Aphasia
Time frame: 3-4 days after stimulation, and 3 months after enrollment
Plan to share: No
Ran from Jun 2017 to primary completion in Jul 2021, 48 months.
Of 3,108 non-industry interventional studies with no phase under Stroke, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 46. This study's 48 months is above that.
Counting every sponsor, half of 3,252 studies reached it within 23 months; a quarter within 10 and three quarters within 46.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in May 2022. You cannot join it, but the record below documents what was studied.
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