Augmentation of Working Memory Training With Transcranial Direct Current Stimulation in Patients With Schizophrenia

NCT03621540 | Completed

• 1 other identifier: ESPRIT Training
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 2

Brief Summary

Cognitive impairment is a core symptom of schizophrenia and is in a large part responsible for the poor psychosocial outcome of the disorder. The use of non-invasive brain stimulation techniques as a therapeutic option is just commencing for neuropsychiatric patients. Concerning healthy subjects the investigators have previously shown that anodal tDCS to the right dorsolateral prefrontal cortex (DLPFC) parallel to working memory training can sustainingly enhance performance in a spatial n-back task. Additionally, first translational experiments regarding the use of anodal tDCS to improve working memory (WM) in patients with schizophrenia rendered promising results. On those grounds, the investigators now test the hypothesis that anodal tDCS to the right DLPFC can augment working memory training in patients with schizophrenia.

Conditions

Schizophrenia; Cognitive Deficits

Keywords

transcranial direct current stimulation; schizophrenia; cognitive deficits; working memory training

Outcome Measures

Primary Outcomes (1)

• Change (post training - pre training) in working memory task performance (1-,2-,3-back).

  Use of d' and response time as dependent variables. Based on signal detection theory, the discriminability index d' (d-prime) is calculated by using the formula d' = Z(hit rate) - Z(false alarm rate).

  Pre Training: 3-4 days before training start. Post Training: 3-4 days after completion of working memory training.

Secondary Outcomes (16)

• Change (post training - pre training) in cognitive flexibility and processing speed.

  Pre Training: 3-4 days before training start. Post Training: 3-4 days after completion of training. And changes in follow-up sessions: 4 and 12 weeks after completion of working memory training.

• Change (follow-up - pre training) in cognitive flexibility and processing speed.

  Pre Training: 3-4 days before training start. Follow-up sessions: 4 and 12 weeks after completion of working memory training.

• Change (post training - pre training) in cognition.

  Pre Training: 3-4 days before training start. Post Training: 3-4 days after completion of training. And changes in follow-up sessions: 4 and 12 weeks after completion of working memory training.

• Change (follow-up - pre training) in cognition.

  Pre Training: 3-4 days before training start. Follow-up sessions: 4 and 12 weeks after completion of working memory training.

• Change (follow-up - pre training) in working memory task performance (1-,2-,3-back).

  Pre Training: 3-4 days before training start. Follow up: 4 and 12 weeks after completion of working memory training.

Other Outcomes (3)

• Influence of genetic constitution on tDCS effectiveness

  Pre Training: 3-4 days before training start

• Influence of age on tDCS effectiveness

  Pre Training: 3-4 days before training start

• Influence of sex on tDCS effectiveness

  Pre Training: 3-4 days before training start

Study Arms (2)

Verum arm

ACTIVE COMPARATOR

25 min anodal tDCS + adaptive working memory training

Device: active tDCS; Behavioral: Adaptive working memory training

Sham arm

SHAM COMPARATOR

sham tDCS + adaptive working memory training

Device: sham tDCS; Behavioral: Adaptive working memory training

Interventions

active tDCS DEVICE

Using the NeuroConn Plus tDCS device, 2 mA anodal tDCS will be applied to the right dorsolateral prefrontal cortex (F4). 15 s fade in and fade out. Total stimulation time of 1365 s. Cathode over contralateral deltoid muscle.

Verum arm

sham tDCS DEVICE

Sham mode of the NeuroConn Plus tDCS device with 2 mA stimulation for 45 s at the beginning. Anode over right dorsolateral prefrontal cortex (F4), Cathode over contralateral deltoid muscle. After that, only continuous impedance checking is performed.

Sham arm

Adaptive working memory training BEHAVIORAL

Adaptive spatial n-back training.

Sham arm; Verum arm

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• diagnosis of schizophrenia or schizoaffective disorder
• age 18-60 years
• Ability to give informed consent
• right handedness
• stable antipsychotic medication one week prior to the experiment and during the training sessions

You may not qualify if:

• epilepsy
• metal implants near the head
• pregnancy
• use of antiepileptics
• use of benzodiazepines \> 1 mg lorazepam equivalent
• current substance abuse (excluding tabacco)
• missing consent of the legal representative, if existing

Sponsors & Collaborators

• University Hospital Tuebingen: lead
• German Federal Ministry of Education and Research: collaborator

Study Sites (2)

Department of Psychiatry and Psychotherapy at the Heinrich-Heine-University Duesseldorf

Düsseldorf, North Rhine-Westphalia, 40629, Germany

Location

University Hospital Tuebigen, Department of Psychiatry and Psychotherapy

Tübingen, 72076, Germany

Location

MeSH Terms

Conditions

Schizophrenia; Cognition Disorders

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Neurocognitive Disorders

Study Officials

• Andreas J Fallgatter, M.D.

  University Hospital Tuebingen, Department of Psychiatry

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Use of NeuroConn Stimulator study mode
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 8, 2018
• First Posted: August 8, 2018
• Study Start: April 20, 2018
• Primary Completion: December 30, 2022
• Study Completion: May 30, 2023
• Last Updated: October 6, 2023

Record last verified: 2023-09

Locations

DE (2)