Acupuncture and Computer-based Training to Improve Attention Deficits in Patients After Stroke

Study Overview
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Brief Summary
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The purpose of this study is to determine whether acupuncture and computer-based attention training can be combined for more effective post-stroke attentional deficits.

Official Title
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Evaluation of Acupuncture and Attention Training Effects on Patients After Stroke: a Study Protocol of an International Multicentre Study Using a Randomized Single Blinded Three-group Design

Conditions
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Stroke

Intervention / Treatment
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* Device: RehaCom
* Device: Acupuncture


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Admitted to inpatient stroke rehabilitation within six months after first-ever stroke Mild cognitive impairments (attention performance TAP > 1 standard deviation below mean age-matched norm in at least one subtest). Conscious, stable physical condition and signed informed consent of patient. Exclusion Criteria: Severe visual and/or hearing problems Inability to follow instructions (MoCA) Disorders of speech and instruction comprehension (tested with a modified token-test) Severe visual and/or hearing problems Pre-existing mental disorders - Pregnancy

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Acupuncture<br>Needling of affected meridian groups in line with Traditional Chinese Medicine procedures (Baihui and Shenting). | Device: Acupuncture<br>* The affected meridian group is treated by needling on Baihui (GV20|DU20) and Shenting (GV24|DU24) - both acupoints of the Governor Vessel. Baihui is 5 cun (1cun=3.33 cm) superior to the anterior hairline on the anterior median line (midpoint of the connecting line between the auricular apices).<br>|
| Active Comparator: Computer-based<br>Computer-based attention training (RehaCom). | Device: RehaCom<br>* The computer-based neurorehabilitation program is intended for patients with acquired cognitive deficits after brain damage, e.g. after stroke. The RehaCom software has five different therapeutic groups aimed at restoration of attention, memory, executive functions, and visual field, respectively. Each group has one to four different modules to choose from for each therapy session. Only attention will be trained in this study.<br>* Other names: computer-based attention training;|
| Experimental: ACoTrain<br>A combination of computer-based attention training with acupuncture. | Device: RehaCom<br>* The computer-based neurorehabilitation program is intended for patients with acquired cognitive deficits after brain damage, e.g. after stroke. The RehaCom software has five different therapeutic groups aimed at restoration of attention, memory, executive functions, and visual field, respectively. Each group has one to four different modules to choose from for each therapy session. Only attention will be trained in this study.<br>* Other names: computer-based attention training;Device: Acupuncture<br>* The affected meridian group is treated by needling on Baihui (GV20|DU20) and Shenting (GV24|DU24) - both acupoints of the Governor Vessel. Baihui is 5 cun (1cun=3.33 cm) superior to the anterior hairline on the anterior median line (midpoint of the connecting line between the auricular apices).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline in attention performance at 4 weeks (Test Battery for Attention Performance (TAP)) |  | Pretest (day 1), Posttest (4 weeks) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline in time needed for Trail Making Test (TMT A/-B) at four weeks. |  | Pretest (day 1), Posttest (4 weeks) | 
| Change from Baseline in number of errors for the Test des Deux Barrage (T2B) at four weeks. |  | Pretest (day 1), Posttest (4 weeks) | 
| Change from Baseline in number of omissions for the Test des Deux Barrage (T2B) at four weeks. |  | Pretest (day 1), Posttest (4 weeks) | 
| National Institute of Health Stroke Scale (NIH-SS) |  | Pretest (day 1) | 
| Change from baseline in total score of Extended Barthel Index (EBI) at four weeks. |  | Pretest (day 1), Posttest (4 weeks) | 
| Change from baseline score of EuroQol quality of life questionnaire (EQ-5D 3L) at four weeks. |  | Pretest (day 1), Posttest (4 weeks) |