NCT01992991

Brief Summary

The purpose of this study is to investigate the effect of transcranial stimulation for upper limb training of patients with sequelae from an intracranial hemorrhage. Patients receive five days of upper limb occupational therapy training in combination with real or sham stimulation. Patients complete the Jebsen Taylor Hand Function Test before, after and 7 days later. The intervention takes place at patients' home address.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
16

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2013

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 11, 2013

Completed
14 days until next milestone

First Posted

Study publicly available on registry

November 25, 2013

Completed
6 days until next milestone

Study Start

First participant enrolled

December 1, 2013

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2014

Completed
Last Updated

February 19, 2014

Status Verified

February 1, 2014

Enrollment Period

4 months

First QC Date

November 11, 2013

Last Update Submit

February 17, 2014

Conditions

Cerebrovascular Disorders

Keywords

transcranial stimulationIntracranial hemorrhageHome trainingOccupational TherapyJebsen Taylor Hand Function Test

Outcome Measures

Primary Outcomes (1)

  • Change in Jebsen Taylor Hand Function Test

    Involves seven items regarding activities of daily living

    Change from baseline until 7 days follow-up

Study Arms (2)

Transcranial direct current stimulation

EXPERIMENTAL

Anodal stimulation

Device: Transcranial direct current stimulation

Sham stimulation

SHAM COMPARATOR

30 sek of Transcranial direct current stimulation

Device: Transcranial direct current stimulation

Interventions

Transcranial direct current stimulationDEVICE

Transcranial direct current stimulation of motor cortex

Sham stimulationTranscranial direct current stimulation

Eligibility Criteria

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

You may qualify if:

  • Intracranial hemorrhage
  • Injury between 6 months and 5 years

You may not qualify if:

  • Traumatic brain injury
  • Other neurological disorders
  • Epilepsy
  • Metal implants in the head

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hammel Neurorehabilitation and Research Centre

Hammel, Jutland, 8450, Denmark

Location

MeSH Terms

Conditions

Cerebrovascular DisordersIntracranial Hemorrhages

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesHemorrhagePathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeuticsConvulsive TherapyPsychiatric Somatic TherapiesBehavioral Disciplines and ActivitiesElectroshockPsychological Techniques

Study Officials

  • Henning Andersen, MD, PhD

    Hammel Neurorehabilitation and Research Centre

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 11, 2013

First Posted

November 25, 2013

Study Start

December 1, 2013

Primary Completion

April 1, 2014

Study Completion

April 1, 2014

Last Updated

February 19, 2014

Record last verified: 2014-02

Locations

DK(1)