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

February 17, 2014 updated by: University of Aarhus

Transcranial Direct Current Stimulation for Upper Limb Training of Individuals With Sequelae From Intracranial Hemorrhage

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

16

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
    • Jutland
      • Hammel, Jutland, Denmark, 8450
        • Hammel Neurorehabilitation and Research Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Change from baseline until 7 days follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Aarhus

Investigators

  • Study Director: Henning Andersen, MD, PhD, Hammel Neurorehabilitation and Research Centre

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2013

Primary Completion (Anticipated)

April 1, 2014

Study Completion (Anticipated)

April 1, 2014

Study Registration Dates

First Submitted

November 11, 2013

First Submitted That Met QC Criteria

November 18, 2013

First Posted (Estimate)

November 25, 2013

Study Record Updates

Last Update Posted (Estimate)

February 19, 2014

Last Update Submitted That Met QC Criteria

February 17, 2014

Last Verified

February 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • tDCS-RHN

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Cerebrovascular Disorders

Clinical Trials on Transcranial direct current stimulation

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Moldova

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe