Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Transcranial Stimulation for Upper Limb Training of Individuals With Sequelae From Intracranial Hemorrhage (tDCS-ICH)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01992991
Recruitment Status : Unknown
Verified February 2014 by University of Aarhus.
Recruitment status was:  Active, not recruiting
First Posted : November 25, 2013
Last Update Posted : February 19, 2014
Sponsor:
Information provided by (Responsible Party):
University of Aarhus

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.


Condition or disease Intervention/treatment Phase
Cerebrovascular Disorders Device: Transcranial direct current stimulation Not Applicable

Detailed Description:

Aim: To investigate the effect of anodal transcranial direct current stimulation (tDCS) for upper limb training of individuals with sequelae from intracranial hemorrhage.

Design: Triple-blinded randomised controlled trial Study population: Patients with intracranial hemorrhage (ICH) of non-traumatic aetiology. Between 6 months and five years from injury.

Intervention:

Group 1 receive five days of upper limb occupational therapy in combination with anodal stimulation Group 2 receive five days of upper limb occupational therapy in combination with sham stimulation The intervention takes place at patients' home address. Assessment tool: Patients complete the Jebsen Taylor Hand Function Test at baseline, post-intervention and at 7 days follow-up.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Transcranial Direct Current Stimulation for Upper Limb Training of Individuals With Sequelae From Intracranial Hemorrhage
Study Start Date : December 2013
Estimated Primary Completion Date : April 2014
Estimated Study Completion Date : April 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding

Arm Intervention/treatment
Experimental: Transcranial direct current stimulation
Anodal stimulation
Device: Transcranial direct current stimulation
Transcranial direct current stimulation of motor cortex

Sham Comparator: Sham stimulation
30 sek of Transcranial direct current stimulation
Device: Transcranial direct current stimulation
Transcranial direct current stimulation of motor cortex




Primary Outcome Measures :
  1. Change in Jebsen Taylor Hand Function Test [ Time Frame: Change from baseline until 7 days follow-up ]
    Involves seven items regarding activities of daily living



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Intracranial hemorrhage
  • Injury between 6 months and 5 years

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01992991


Locations
Layout table for location information
Denmark
Hammel Neurorehabilitation and Research Centre
Hammel, Jutland, Denmark, 8450
Sponsors and Collaborators
University of Aarhus
Investigators
Layout table for investigator information
Study Director: Henning Andersen, MD, PhD Hammel Neurorehabilitation and Research Centre
Layout table for additonal information
Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT01992991    
Other Study ID Numbers: tDCS-RHN
First Posted: November 25, 2013    Key Record Dates
Last Update Posted: February 19, 2014
Last Verified: February 2014
Keywords provided by University of Aarhus:
transcranial stimulation
Intracranial hemorrhage
Home training
Occupational Therapy
Jebsen Taylor Hand Function Test
Additional relevant MeSH terms:
Layout table for MeSH terms
Intracranial Hemorrhages
Cerebrovascular Disorders
Hemorrhage
Pathologic Processes
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases