The Treatment Effectiveness of Combined tDCs and Neurofeedback (NF) for Patients With Cognitive Deficits After Stroke

Recruiting

Phase N/A Results N/A

Trial Description

This is a double blinded, randomized control trial with a pretest-posttest control and interventional groups design. Both the assessor and participants are blinded to all assessments and evaluations. All patients with subacute stroke undergo in-patient or out-patient rehabilitation are screened initially by a series of screening test. Suitable patients are assigned randomly to 3 groups respectively. Group 1 is the combined transcranial direct current stimulation (tDCS) and neurofeedback group. Group 2 is the neurofeedback group. Group 3 is the control group with sham neurofeedback training.

Detailed Description

Treatment sessions for all three groups are conducted by the investigators who has training in neurofeedback and transcranial direct current stimulation (tDCs). Each participant performed 10 training sessions on different days. Sessions were conducted 3-5 times a week The tDCS + neurofeedback group will carry out 30 minutes tDCS and neurofeedback.
The real neurofeedback group will carry out neurofeedback training. The sham neurofeedback group will conduct the sham neurofeedback training.

Conditions

Interventions

  • TDCS&neurofeedback&computer remediation Device
    Intervention Desc: tDCs and neurofeedback and computer remediation
    ARM 1: Kind: Experimental
    Label: tDCS&neurofeedback&computer remediation
    Description: 30 minutes neurofeedback and 30 minutes tDCs simultaneously with computer remediation.
  • Neurofeedback&computer remediation Device
    Intervention Desc: Neurofeedback and computer remediation
    ARM 1: Kind: Experimental
    Label: neurofeedback&computer remediation
    Description: 30 minutes neurofeedback and 30 minutes computer remediation.
  • Sham neurofeedback&computer remediation Device
    Intervention Desc: sham neurofeedback and computer remediation
    ARM 1: Kind: Experimental
    Label: sham neurofeedback&computer remediation
    Description: 30 minutes sham neurofeedback and 30 minutes computer remediation.
  • TDCS&neurofeedback Device
    Intervention Desc: tDCs and neurofeedback
    ARM 1: Kind: Experimental
    Label: tDCS&neurofeedback
    Description: neurofeedback and tDCs.
  • Neurofeedback Device
    Intervention Desc: Neurofeedback
    ARM 1: Kind: Experimental
    Label: neurofeedback
    Description: 30 minutes neurofeedback.
  • Sham neurofeedback Device
    Intervention Desc: sham neurofeedback
    ARM 1: Kind: Experimental
    Label: sham neurofeedback
    Description: 30 minutes sham neurofeedback.

Outcomes

Type Measure Time Frame Safety Issue
Primary Change score in Trail Making Test A & B from baseline One day before the treatment , up to 4 weeks, up to 16 weeks
Secondary Change score in Executive function performance Test (EFPT) from baseline One day before the treatment , up to 4 weeks, up to 16 weeks
Secondary Change score in Functional Independence Measure (FIM) from basline One day before the treatment , up to 4 weeks, up to 16 weeks
Secondary Change score in Stroke Adapted 30 item version of the Sickness Impact Profile (SA - SIP 30) One day before the treatment , up to 4 weeks, up to 16 weeks
Secondary Change score in Stroop Test from baseline One day before the treatment , up to 4 weeks, up to 16 weeks
Secondary Chaneg score in Rivermead Behavioral Memory Test from baseline One day before the treatment , After 10 treatment sessions, 3 months follow up after 10 sessions
Secondary Change score in Paced Auditory Serial Addition Test (PASAT) from baseline One day before the treatment , up to 4 weeks, up to 16 weeks

Sponsors