Transcranial Direct Current Stimulation (tDCS) as a Cognitive Enhancer for Patients With Alzheimers Disease

NCT ID: NCT02518412

Last Updated: 2015-08-11

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-05-31
• Study Completion Date: 2016-02-29

Brief Summary

The purpose of this study is to investigate transcranial direct current stimulation (tDCS) as a cognitive enhancer for patients with Alzheimer disease.

Transcranial direct current stimulation (tDCS) is a neuromodulation technique, that are applied to the brain by using two electrodes. These electrodes are placed on the scalp. The current is low intensity, usually 1-2 milliampere. tDCS may affect cognitive functions by increasing cortical excitability. tDCS is regarded as a safe treatment approach. In the present study, participants will undergo six stimulations. The effect of all stimulations swill be measured with neuropsychological testing before the first (pre) and after the sixth tDCS stimulation (post).

Detailed Description

The present study is a randomized controlled study (RCT) and will use tDCS to stimulate left temporal lobe and hopefully improve verbal memory functions. A total of 30 patients with Alzheimer disease will receive tDCS treatment for 30 minutes, six times. Half of the patients will undergo sham stimulation. These six stimulations will be executed during 10 days. Patients will be tested with neuropsychological tests before the first stimulation and after the last stimulation to assess the effect of the treatment. Patients will be retested six months later in order to investigate long-term effects ot the stimulation. The main hypothesis in the present study is that tDCS stimulation will lead to significant improvements in verbal memory functions.

Conditions

Alzheimer Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Active tDCS

Participants receive active tDCS stimulation. Half of the participants receive active tDCS stimulation, i.e 30 minutes active stimulation of the temporal cortex.

Group Type: EXPERIMENTAL

tDCS

Intervention Type: OTHER

Transcranial Direct Current Stimulation (tDCS) is a non-invasive treatment method, using a low Direct current stimulation to increase excitability and thus stimulate plasticity and cognitive functions.

Placebo tDCS

Participants receive placebo tDCS stimulation. Half of the participants receive placebo tDCS stimulation, i.e 30 minutes inactive stimulation of the temporal cortex.

Group Type: PLACEBO_COMPARATOR

Placebo tDCS

Intervention Type: OTHER

Half of the patients will receive Placebo tDCS. The procedure is the same as for active tDCS, but the in the Placebo tDCS the stimulation is non-active / sham.

Interventions

tDCS

Transcranial Direct Current Stimulation (tDCS) is a non-invasive treatment method, using a low Direct current stimulation to increase excitability and thus stimulate plasticity and cognitive functions.

Intervention Type: OTHER

Placebo tDCS

Half of the patients will receive Placebo tDCS. The procedure is the same as for active tDCS, but the in the Placebo tDCS the stimulation is non-active / sham.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Alzheimers disease according to (National Institute of Neurological and Communicative Disorders and Stroke and the Alzheimer's Disease and Related Disorders Association).
• The cognitive impairment and decline must be documented by cognitive / neuropsychological testing and from an informant.

Exclusion Criteria

• Stroke,
• Cancer,
• Psychiatric disorders (major depression, psychosis) or diseases / injuries in the central nervous system.

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Tromso

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Per M Aslaksen, PhD

Role: STUDY_DIRECTOR

University of Tromso

Locations

Department of Psychology, University of Tromsø

Tromsø, , Norway

Site Status: RECRUITING

Countries

Norway

Central Contacts

Per M Aslaksen, PhD

Role: CONTACT

0047776 49234

Martin K Bystad, Cand.psychol

Role: CONTACT

0047760809

Facility Contacts

Per M Aslaksen, PhD

Role: primary

004777649234

Martin K Bystad, Cand.Psychol

Role: backup

004777620809

References

Bystad M, Gronli O, Rasmussen ID, Gundersen N, Nordvang L, Wang-Iversen H, Aslaksen PM. Transcranial direct current stimulation as a memory enhancer in patients with Alzheimer's disease: a randomized, placebo-controlled trial. Alzheimers Res Ther. 2016 Mar 23;8(1):13. doi: 10.1186/s13195-016-0180-3.

Reference Type: DERIVED

PMID: 27005937 (View on PubMed)

Other Identifiers

2012/1890(REK)

Identifier Type: -

Identifier Source: org_study_id