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.
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.
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:
- 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).
- 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.
- 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.
- Conditions
- Geriatric In-patients
- 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 group | Role | What they receive |
|---|---|---|
| Stimulation Group | Experimental | Will 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 stim | Sham comparator | Same 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.
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)
Geriatric Depression Score
Survey assessing depression level of subject
Measured: applied within 1 week of admission and then at 3 and 5 weeks
Geriatric Anxiety Score
Survey assessing anxiety level of subject
Measured: applied within 1 week of admission and then at 3 and 5 weeks
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.
- First posted22 Sep 2020
- Study start5 Nov 2018
- Primary completion9 Feb 2020
- Study completion9 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Geriatric In-patientsStudies of the same condition, open and under way.
- More trials run by University of AlbertaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- University of Alberta
- Sponsor type
- University, hospital or other
- Collaborators
- Glenrose Foundation, Centre for Aging and Brain Health Innovation
- Responsible party
- Sponsor
- Investigators
- Hubert Kammerer, MD, Principal investigator, Alberta Health services
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 27866120Figeys 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
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Repetitive Transcranial Stimulation to Treat Depression and Anxiety in Senior Inpatients
- ClinicalTrials.gov ID
- NCT04558177
- Acronym / sponsor ID
- Pro00078317
- Conditions
- Geriatric In-patients
- Keywords
- depression, anxiety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of AlbertaUniversity, hospital or other
- Collaborators
- Glenrose Foundation, Centre for Aging and Brain Health Innovation
- Study start
- 5 Nov 2018 (actual)
- Primary completion
- 9 Feb 2020 (actual)
- Study completion
- 9 Feb 2020 (actual)
- First posted
- 22 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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:
- 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).
- 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.
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- double blind placebo controlled
| Arm | Type | Receives |
|---|---|---|
| Stimulation Group | Experimental | Device: Direct current stimulatorWill receive ~1.5mA transcranial stimulation for 20 minutes, 5x per week from a direct current stimulator |
| Device placed only, no stim | Sham comparator | Device: Direct current stimulatorSame as experimental group but the stimulation from the direct current stimulator will be initiated and then stopped |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- being treated for an infection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Direct current stimulatorHDCprog 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 | Device placed only, no stim, Stimulation Group |
Primary outcome
Length of stay
Time frame: average length of stay varies from 28 to 42 days
How long the patient is in hospital measured in days
3 secondary outcomes
Geriatric Depression Score
Time frame: applied within 1 week of admission and then at 3 and 5 weeks
Geriatric Anxiety Score
Time frame: applied within 1 week of admission and then at 3 and 5 weeks
Older Person Quality of Life Questionnaire
Time frame: applied within 1 week of admission and then at 3 and 5 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2022.
- Background: PubMed 27866120Lefaucheur 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.
- Derived from this study: PubMed 36386776Figeys 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.
- Adverse events of tDCS and tACS: A review. Hideyuki Matsumoto a,⇑, Yoshikazu Ugawa. Clinical Neurophysiology Practice 2 (2017) 19-25Link provided by the sponsor.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hubert Kammerer, MD principal investigator
Alberta Health services
1 site in 1 country: see every site and its status.
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.