Repetitive Transcranial Stimulation to Treat Depression and Anxiety in Senior Inpatients

NCT04558177 | Completed

• 1 other identifier: Pro00078317
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Many seniors admitted for rehabilitation have symptoms of depression and anxiety that need to be treated before they can effectively engage in rehabilitation therapy. Anti-depressant or anti-anxiety medications are often used but there are many reasons why alternative or adjunctive treatments may be desirable. Medications can take weeks to become effective, if they work at all. There are many potential side effects of medications, especially in an older population, including cognitive and other neurologic impairments. There is also an increasing resistance to a polypharmacy approach to treatment in this population. A low-risk, relatively non-invasive, easily applied and well-tolerated treatment to accelerate mood and anxiety disorder resolution would allow earlier and more effective engagement in rehabilitation therapy. This would in turn shorten lengths of stay and improve quality of life. Recently, trans-cranial direct current stimulation with 1-2 mA currents has been proposed as a potential innovative alternative treatment modality. This stimulation is safe, easy to use, relatively insensitive to electrode placement, and may have other beneficial cognitive effects. The stimulation device consists of two electrodes placed on either side of the head, a unit that provides the stimulation and wires that connect this unit to the electrodes will be used. The electrodes are held in place with a head band.

Conditions

Geriatric In-patients

Keywords

depression; anxiety

Outcome Measures

Primary Outcomes (1)

• Length of stay

  How long the patient is in hospital measured in days

  average length of stay varies from 28 to 42 days

Secondary Outcomes (3)

• Geriatric Depression Score

  applied within 1 week of admission and then at 3 and 5 weeks

• Geriatric Anxiety Score

  applied within 1 week of admission and then at 3 and 5 weeks

• Older Person Quality of Life Questionnaire

  applied within 1 week of admission and then at 3 and 5 weeks

Study Arms (2)

Stimulation Group

EXPERIMENTAL

Will receive \~1.5mA transcranial stimulation for 20 minutes, 5x per week from a direct current stimulator

Device: Direct current stimulator

Device placed only, no stim

SHAM COMPARATOR

Same as experimental group but the stimulation from the direct current stimulator will be initiated and then stopped

Device: Direct current stimulator

Interventions

Direct current stimulator DEVICE

HDCprog connected to a direct current stimulator, controls the number of stimulations (maximum 99), the intensity (up to 1.5mA per channel), the duration (maximum 20min), and the minimum interval between two consecutive simulations (max 1168 hours). A sham condition is also available which will ramp the stimulation to a preset maximum level and then immediately reduces the stimulation to 0.

Device placed only, no stim; Stimulation Group

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Patients above 65 years old
• a Geriatric Depression Score above 4
• cognitively sound enough to give consent
• know English well enough to understand the procedure

You may not qualify if:

• being treated for an infection

Sponsors & Collaborators

• University of Alberta: lead
• Glenrose Foundation: collaborator
• Centre for Aging and Brain Health Innovation: collaborator

Study Sites (1)

Glenrose Rehabilitation Hospital

Edmonton, Alberta, T5G 0B7, Canada

Location

Related Publications (2)

• Lefaucheur JP, Antal A, Ayache SS, Benninger DH, Brunelin J, Cogiamanian F, Cotelli M, De Ridder D, Ferrucci R, Langguth B, Marangolo P, Mylius V, Nitsche MA, Padberg F, Palm U, Poulet E, Priori A, Rossi S, Schecklmann M, Vanneste S, Ziemann U, Garcia-Larrea L, Paulus W. Evidence-based guidelines on the therapeutic use of transcranial direct current stimulation (tDCS). Clin Neurophysiol. 2017 Jan;128(1):56-92. doi: 10.1016/j.clinph.2016.10.087. Epub 2016 Oct 29.

  PMID: 27866120 BACKGROUND

• Figeys M, Villarey S, Leung AWS, Raso J, Buchan S, Kammerer H, Rawani D, Kohls-Wiebe M, Kim ES. tDCS over the left prefrontal Cortex improves mental flexibility and inhibition in geriatric inpatients with symptoms of depression or anxiety: A pilot randomized controlled trial. Front Rehabil Sci. 2022 Oct 25;3:997531. doi: 10.3389/fresc.2022.997531. eCollection 2022.

  PMID: 36386776 DERIVED

Related Links

• Adverse events of tDCS and tACS: A review. Hideyuki Matsumoto a,⇑, Yoshikazu Ugawa. Clinical Neurophysiology Practice 2 (2017) 19-25

MeSH Terms

Conditions

Depression; Anxiety Disorders

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders

Study Officials

• Hubert Kammerer, MD

  Alberta Health services

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: sham procedure appears indistinguishable from intervention
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: double blind placebo controlled

Study Record Dates

• First Submitted: September 16, 2020
• First Posted: September 22, 2020
• Study Start: November 5, 2018
• Primary Completion: February 9, 2020
• Study Completion: February 9, 2020
• Last Updated: July 12, 2022

Record last verified: 2022-07

Locations

CA (1)