Overview

This trial is active, not recruiting.

Condition cerebrovascular disorders
Treatment transcranial direct current stimulation
Sponsor University of Aarhus
Start date December 2013
End date April 2014
Trial size 16 participants
Trial identifier NCT01992991, tDCS-RHN

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
Anodal stimulation
transcranial direct current stimulation
Transcranial direct current stimulation of motor cortex
(Sham Comparator)
30 sek of Transcranial direct current stimulation
transcranial direct current stimulation
Transcranial direct current stimulation of motor cortex

Primary Outcomes

Measure
Change in Jebsen Taylor Hand Function Test
time frame: Change from baseline until 7 days follow-up

Eligibility Criteria

Male or female participants from 18 years up to 80 years old.

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

Additional Information

Official title Transcranial Direct Current Stimulation for Upper Limb Training of Individuals With Sequelae From Intracranial Hemorrhage
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.
Trial information was received from ClinicalTrials.gov and was last updated in February 2014.
Information provided to ClinicalTrials.gov by University of Aarhus.