NCT02324959

Brief Summary

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.

Trial Health

47
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P50-P75 for not_applicable stroke

Timeline
Completed

Started Nov 2014

Geographic Reach
3 countries

3 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2014

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

December 8, 2014

Completed
16 days until next milestone

First Posted

Study publicly available on registry

December 24, 2014

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2015

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2016

Completed
Last Updated

December 24, 2014

Status Verified

December 1, 2014

Enrollment Period

1 year

First QC Date

December 8, 2014

Last Update Submit

December 19, 2014

Conditions

Stroke

Outcome Measures

Primary Outcomes (1)

  • Change from Baseline in attention performance at 4 weeks (Test Battery for Attention Performance (TAP))

    Pretest (day 1), Posttest (4 weeks)

Secondary Outcomes (6)

  • 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)

  • +1 more secondary outcomes

Study Arms (3)

Acupuncture

ACTIVE COMPARATOR

Needling of affected meridian groups in line with Traditional Chinese Medicine procedures (Baihui and Shenting).

Device: Acupuncture

Computer-based

ACTIVE COMPARATOR

Computer-based attention training (RehaCom).

Device: RehaCom

ACoTrain

EXPERIMENTAL

A combination of computer-based attention training with acupuncture.

Device: RehaComDevice: Acupuncture

Interventions

RehaComDEVICE

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.

Also known as: computer-based attention training
ACoTrainComputer-based
AcupunctureDEVICE

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).

ACoTrainAcupuncture

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Fujian University of Traditional Chinese Medicine

Fuzhou, Fujian, 350003, China

RECRUITING

m&i Fachklinik Herzogenaurach

Herzogenaurach, Bavaria, 91074, Germany

RECRUITING

Reha Rheinfelden

Rheinfelden, Canton of Aargau, 4310, Switzerland

NOT YET RECRUITING

Related Publications (1)

  • Huang J, McCaskey MA, Yang S, Ye H, Tao J, Jiang C, Schuster-Amft C, Balzer C, Ettlin T, Schupp W, Kulke H, Chen L. Effects of acupuncture and computer-assisted cognitive training for post-stroke attention deficits: study protocol for a randomized controlled trial. Trials. 2015 Dec 2;16:546. doi: 10.1186/s13063-015-1054-x.

    PMID: 26631161DERIVED

MeSH Terms

Conditions

Stroke

Interventions

Acupuncture Therapy

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeutics

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr.

Study Record Dates

First Submitted

December 8, 2014

First Posted

December 24, 2014

Study Start

November 1, 2014

Primary Completion

November 1, 2015

Study Completion

January 1, 2016

Last Updated

December 24, 2014

Record last verified: 2014-12

Locations

DE(1)CH(1)CN(1)