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Geriatric In-patientsNCT04558177

Repetitive Transcranial Stimulation to Treat Depression and Anxiety in Senior Inpatients

A study testing Direct current stimulator in people with Geriatric In-patients, run by University of Alberta at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 65 years and older
Conditions the study is for
Geriatric In-patients
What is being tested?
Direct current stimulator
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
60 participants
Where
1 siteCanada
Study dates
5 Nov 2018to 9 Feb 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 65 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

  • 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

Who cannot join

  • being treated for an infection

Trial locations and contacts

1 site in 1 country.

Canada1 site
  • Glenrose Rehabilitation Hospital

    Edmonton, Alberta, T5G 0B7

Other trials in Canada

About this study

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.

Read the detailed description

Purpose: To determine if using adjunctive TDCS to treat seniors admitted with symptoms of depression and anxiety reduces length of stay and improves quality of life. Hypothesis: Using transcranial direct current stimulation (TDCS) will decrease length of stay because it will reduce symptoms of depression and anxiety enabling patients to engage with their therapy sooner and more effectively. Justification: Anti-depressant or anti-anxiety medications are often used for this inpatient population 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. Objectives: to determine if (1) TDCS reduces symptoms of depression and anxiety and (2) if patients in the intervention group are discharged from hospital sooner than those in the sham group. Research Method/Procedure: Direct current of 1.5 milliamp (mA) will be applied for 20 minutes 5x/week for 3 weeks in a hemispheric montage over the homologous dorso-lateral prefrontal cortices, anodal on the left. The Glenrose Rehabilitation Hospital is Canada's largest freestanding rehabilitation institution with programs and services for all age groups. Rehabilitation services cover all disciplines from physical, occupational therapy to social work. Older adults are admitted to 3D and 4C to address issues related to frailty such as weakness and poor balance which affect ability to undertake activities of daily living. Most of the services they receive as inpatients come from physical and occupational therapists with speech therapists and psychologists also available if needed.Patients will be drawn from these seniors admitted to these 2 geriatrics units, 3D and 4C. Candidates who meet the eligibility criteria and are interested in the project will be approached by the RA who is not involved in their care and will seek their consent. Patients will be randomized into standard care (SoC) plus active TDCS and SoC with sham TDCS. TDCS is unique in that effective double blind sham conditions can be created. Effectiveness of treatment will be judged primarily on reduced length of stay with improved Geriatric Depression Score (GDS), Geriatric Anxiety Score (GAS) and Older Person's Quality of Life (OPQOL) as secondary outcome measures. We expect that it will take ~8 months to complete the study: 3 months for ethics review, 4 months to enroll 100 of a possible 200 eligible patients and 1 for data analysis.

This intervention will be judged primarily on its effect on length of stay for this population. It is our working hypothesis that this intervention will shorten length of stay by approximately 5 days. It will do this because TDCS will improve depression (GDS less than 5/15) and anxiety symptoms (score less than 9/30) and thus increase motivation and engagement. Readiness to proceed with therapy is a clinical judgement based on patient demeanour and GDS made by the Unit team who will be blind with respect to whether the patient is receiving TDCS or part of the sham group. Data will include: demographics: gender, age and diagnosis. Geriatric Anxiety Inventory, Geriatric Depression and Quality of Life scales will be completed within 1 week of admission, and at ~ 3 and 5 weeks (+3 days) after intervention initiated. Testing will be coordinated with the Unit Occupational Therapist to avoid duplication or the risk of over testing.

Data analysis:

  1. Baseline group statistics (mean age \&, standard deviation, male/female count, diagnostic frequencies, initial mean \& standard deviations of GDS, Geriatric Anxiety Inventory and Quality of Life scores).
  2. Effect of length of stay: Student t test will be used to determine if there is a significant difference between the 2 groups, defined as p<0.05.
  3. Changes in Depression, anxiety or quality of life: significant differences from baseline at 3 and 5 weeks intervals will be assessed based on minimum clinical differences using a chi squared test.
Being tested
Direct current stimulator
Keywords
depression, anxiety
Medical subject headings
Depression, Anxiety Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Direct current stimulatorDevice

    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.

Study groups in NCT04558177
Study groupRoleWhat they receive
Stimulation GroupExperimentalWill receive ~1.5mA transcranial stimulation for 20 minutes, 5x per week from a direct current stimulator
Receives: Device: Direct current stimulator
Device placed only, no stimSham comparatorSame as experimental group but the stimulation from the direct current stimulator will be initiated and then stopped
Receives: Device: Direct current stimulator

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Length of stay

    How long the patient is in hospital measured in days

    Measured: average length of stay varies from 28 to 42 days

Secondary outcomes (3)
  1. Geriatric Depression Score

    Survey assessing depression level of subject

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

  2. Geriatric Anxiety Score

    Survey assessing anxiety level of subject

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

  3. Older Person Quality of Life Questionnaire

    Survey assessing subject's impression of thier overall quality of life

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Sep 2020
  2. Study start5 Nov 2018
  3. Primary completion9 Feb 2020
  4. Study completion9 Feb 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
double blind placebo controlled
Masking
Double blind
Who is masked
Participant, Care provider
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04558177
Sponsor's protocol ID
Pro00078317
Status last verified
Jul 2022
First submitted
16 Sep 2020
Last updated
12 Jul 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: We may also use the depression, anxiety and quality of life (QofL) results to look at the effects of direct current stimulation on symptoms of depression and anxiety.

Publications

  • 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.

    PubMed 27866120
  • 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.

    PubMed 36386776

Questions about this trial

What is this clinical trial studying?

A study testing Direct current stimulator in people with Geriatric In-patients, run by University of Alberta at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Length of stay (time frame: average length of stay varies from 28 to 42 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04558177, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jul 2022.

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