ApathyPhase 4NCT02190019
Transcranial Magnetic Stimulation for Apathy in Mild Cognitive Impairment:Pilot Study
A Phase 4 study testing Neurostar repetitive transcranial magnetic stimulator in people with Apathy and Mild Cognitive Impairment, run by Central Arkansas Veterans Healthcare System at 1 site in United States.
Trial summary
Mild cognitive impairment (MCI) is a precursor of dementia. Apathy, a profound loss of motivation, is a common behavioral problem in MCI. Presence of apathy may increase the chance of MCI patients converting to Alzheimer's Dementia. Read more about this study
- Who is it for?
- Ages 55 to 91 years
- Conditions the study is for
- Apathy, Mild Cognitive Impairment
- What is being tested?
- Neurostar repetitive transcranial magnetic stimulator
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2014to Jul 2016
- Phase
- Phase 4
- 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 55 to 91 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects age ≥ 55 years,
- Subjects meeting Petersen's criteria for MCI,
- Apathy Evaluation Scale-Clinician (AES-C) score of ≥ 30,
- Mini Mentla Status Examination (MMSE) ≥ 23,
- Subjects who clear the TMS adult safety scale (TASS)
- On stable dose of antidepressants (if applicable) for at least two months
Who cannot join
- Subjects taking medications known to increase the risk of seizures from the 2012 Beers criteria: Bupropion, chlorpromazine, clozapine, maprotiline, olanzapine, thioridazine, thiothixene, and tramadol.
- Subjects taking medications known to increase seizure threshold not listed in the Beers criteria but in the opinion of PI increase seizure threshold: tricyclic antidepressants, theophylline, methylphenidate, and high-dose thyroid supplementation.
- Subjects taking ototoxic medications: Aminoglycosides, Cisplatin.
- Subjects in current episode of major depression
- History of bipolar disorder
- Subjects with history of seizure or first degree relative with seizure disorder
Show all 10Show fewer
- Subjects with implanted device: wearable or implantable cardioverter defibrillators, conductive, ferromagnetic, or other magnetic sensitive metals that are implanted or are non-removable within 30 cm of the treatment coil or those with cochlear implants
- Subjects with diagnosis of current alcohol related problems
- Subjects with history of stroke , aneurysm, or cranial neurosurgery
- Any condition that in the opinion of the study physician is likely to compromise their ability to safely participate in the study
Trial locations and contacts
1 site in 1 country.
United States1 site
Central Arkansas Veterans Healthcare System
Little Rock, Arkansas, 72205
About this study
Mild cognitive impairment (MCI) is a precursor of dementia. Apathy, a profound loss of motivation, is a common behavioral problem in MCI. Presence of apathy may increase the chance of MCI patients converting to Alzheimer's Dementia. Repetitive Transcranial Magnetic Stimulation (rTMS), a non-invasive tool, has been recently approved for treatment of refractory depression. Since dysfunction in the frontal lobe of the brain is seen in patients with apathy, rTMS to the frontal lobe might be helpful in treating the same. Study hypotheses include that rTMS to the dorsolateral prefrontal cortex (DLPFC) will improve apathy and executive function better than sham treatment in those with MCI
Read the detailed description
Objective: Mild cognitive impairment (MCI) is a precursor of dementia. Apathy, a profound loss of motivation, is a common behavioral problem in MCI. Presence of apathy may increase the chance of MCI patients converting to Alzheimer's Dementia. Repetitive Transcranial Magnetic Stimulation (rTMS), a non-invasive tool, has been recently approved for treatment of refractory depression. Since dysfunction in the frontal lobe of the brain is seen in patients with apathy, rTMS to the frontal lobe might be helpful in treating the same.
Specific Aims:
- To determine the efficacy of rTMS to the dorsolateral prefrontal cortex (DLPFC) in treating apathy in MCI in comparison to sham treatment.
- To compare the efficacy of rTMS to the DLPFC on executive function in MCI in comparison to sham treatment.
Research Plan: Current study is a randomized sham controlled cross-over study of daily rTMS.
Methods: 20 subjects with MCI and apathy will be enrolled to randomize 8 to a total of 20 sessions of treatment (2 weeks sham, 2 weeks rTMS, with 4 weeks of washout period). Subjects will be randomly assigned to rTMS or sham treatment after consent. After 2 weeks of treatment there will be a 4 week period with no treatment. At the end of the 4-week wash out period, subjects will be crossed over to the next treatment arm (i.e. those who received rTMS in the beginning will receive sham treatment and vice versa). Subjects will be followed for four additional weeks after treatment. Apathy will be assessed using the Apathy Evaluation Scale. Memory, executive function, functional status and caregiver burden will be assessed.
- Conditions
- Apathy, Mild Cognitive Impairment
- Being tested
- Neurostar repetitive transcranial magnetic stimulator
- Keywords
- Mild Cognitive Impairment, apathy, executive function
- Medical subject headings
- Lethargy, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neurostar repetitive transcranial magnetic stimulatorDevice
Also called rTMS
The active procedure will stimulate at 120% motor threshold for 4 seconds at a frequency of 10 Hz, with an inter-train interval of 26 seconds for a total of 3,000 pulses. 10 treatment sessions are given over a two week period.
| Study group | Role | What they receive |
|---|---|---|
| transcranial magnetic stimulator | Active comparator | Neurostar repetitive transcranial magnetic stimulator. The active procedure will stimulate at 120% motor threshold for 4 seconds at a frequency of 10 Hz, with an inter-train interval of 26 seconds for a total of 3,000 pulses. 10 treatment sessions are given over a two week period. Receives: Device: Neurostar repetitive transcranial magnetic stimulator |
| Sham coil treatment | Sham comparator | Neurostar repetitive transcranial magnetic stimulator. 10 treatments identical in duration will be administered over a two week period. Receives: Device: Neurostar repetitive transcranial magnetic stimulator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Apathy Evaluation Scale (AES)
AES is an 18-item scale that assesses apathy in behavioral, cognitive and emotional domains over the previous four weeks.
Measured: 8 weeks
Secondary outcomes (1)
Trials making test
Widely used test for assessment of executive function.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2014 (estimated)
- Study startApr 2014
- Primary completionApr 2015
- Study completionJul 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ApathyStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Central Arkansas Veterans Healthcare System
- Sponsor type
- US federal agency
- Responsible party
- Principal investigator, Prasad R. Padala, Central Arkansas Veterans Healthcare System
- Investigators
- Prasad R Padala, MD, MS, Principal investigator, Central Arkansas Veterans Healthcare System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02190019
- Sponsor's protocol ID
- 391721
- Status last verified
- Feb 2016
- First submitted
- 11 Jul 2014
- Last updated
- 10 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Padala PR, Padala KP, Lensing SY, Jackson AN, Hunter CR, Parkes CM, Dennis RA, Bopp MM, Caceda R, Mennemeier MS, Roberson PK, Sullivan DH. Repetitive transcranial magnetic stimulation for apathy in mild cognitive impairment: A double-blind, randomized, sham-controlled, cross-over pilot study. Psychiatry Res. 2018 Mar;261:312-318. doi: 10.1016/j.psychres.2017.12.063. Epub 2018 Jan 5.
PubMed 29331848
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcranial Magnetic Stimulation for Apathy in Mild Cognitive Impairment:Pilot Study
- ClinicalTrials.gov ID
- NCT02190019
- Acronym / sponsor ID
- 391721
- Conditions
- Apathy, Mild Cognitive Impairment
- Keywords
- Mild Cognitive Impairment, apathy, executive function
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Central Arkansas Veterans Healthcare SystemUS federal agency
- Study start
- Apr 2014
- Primary completion
- Apr 2015 (actual)
- Study completion
- Jul 2016 (estimated)
- First posted
- 15 Jul 2014 (estimated)
- 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.
Mild cognitive impairment (MCI) is a precursor of dementia. Apathy, a profound loss of motivation, is a common behavioral problem in MCI. Presence of apathy may increase the chance of MCI patients converting to Alzheimer's Dementia. Repetitive Transcranial Magnetic Stimulation (rTMS), a non-invasive tool, has been recently approved for treatment of refractory depression. Since dysfunction in the frontal lobe of the brain is seen in patients with apathy, rTMS to the frontal lobe might be helpful in treating the same. Study hypotheses include that rTMS to the dorsolateral prefrontal cortex (DLPFC) will improve apathy and executive function better than sham treatment in those with MCI
Detailed description
Objective: Mild cognitive impairment (MCI) is a precursor of dementia. Apathy, a profound loss of motivation, is a common behavioral problem in MCI. Presence of apathy may increase the chance of MCI patients converting to Alzheimer's Dementia. Repetitive Transcranial Magnetic Stimulation (rTMS), a non-invasive tool, has been recently approved for treatment of refractory depression. Since dysfunction in the frontal lobe of the brain is seen in patients with apathy, rTMS to the frontal lobe might be helpful in treating the same.
Specific Aims:
- To determine the efficacy of rTMS to the dorsolateral prefrontal cortex (DLPFC) in treating apathy in MCI in comparison to sham treatment.
- To compare the efficacy of rTMS to the DLPFC on executive function in MCI in comparison to sham treatment.
Research Plan: Current study is a randomized sham controlled cross-over study of daily rTMS.
Methods: 20 subjects with MCI and apathy will be enrolled to randomize 8 to a total of 20 sessions of treatment (2 weeks sham, 2 weeks rTMS, with 4 weeks of washout period). Subjects will be randomly assigned to rTMS or sham treatment after consent. After 2 weeks of treatment there will be a 4 week period with no treatment. At the end of the 4-week wash out period, subjects will be crossed over to the next treatment arm (i.e. those who received rTMS in the beginning will receive sham treatment and vice versa). Subjects will be followed for four additional weeks after treatment. Apathy will be assessed using the Apathy Evaluation Scale. Memory, executive function, functional status and caregiver burden will be assessed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| transcranial magnetic stimulator | Active comparator | Device: Neurostar repetitive transcranial magnetic stimulatorNeurostar repetitive transcranial magnetic stimulator. The active procedure will stimulate at 120% motor threshold for 4 seconds at a frequency of 10 Hz, with an inter-train interval of 26 seconds for a total of 3,000 pulses. 10 treatment sessions are given over a two week period. |
| Sham coil treatment | Sham comparator | Device: Neurostar repetitive transcranial magnetic stimulatorNeurostar repetitive transcranial magnetic stimulator. 10 treatments identical in duration will be administered over a two week period. |
Who may qualify
- Ages
- 55 to 91 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Subjects age ≥ 55 years,
- Subjects meeting Petersen's criteria for MCI,
- Apathy Evaluation Scale-Clinician (AES-C) score of ≥ 30,
- Mini Mentla Status Examination (MMSE) ≥ 23,
- Subjects who clear the TMS adult safety scale (TASS)
Key exclusion criteria (10 listed)
- Subjects taking medications known to increase the risk of seizures from the 2012 Beers criteria: Bupropion, chlorpromazine, clozapine, maprotiline, olanzapine, thioridazine, thiothixene, and tramadol.
- Subjects taking medications known to increase seizure threshold not listed in the Beers criteria but in the opinion of PI increase seizure threshold: tricyclic antidepressants, theophylline, methylphenidate, and high-dose thyroid supplementation.
- Subjects taking ototoxic medications: Aminoglycosides, Cisplatin.
- Subjects in current episode of major depression
- History of bipolar disorder
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 |
|---|---|---|
| Neurostar repetitive transcranial magnetic stimulatorAlso: rTMSThe active procedure will stimulate at 120% motor threshold for 4 seconds at a frequency of 10 Hz, with an inter-train interval of 26 seconds for a total of 3,000 pulses. 10 treatment sessions are given over a two week period. | Device | Sham coil treatment, transcranial magnetic stimulator |
Primary outcome
Apathy Evaluation Scale (AES)
Time frame: 8 weeks
AES is an 18-item scale that assesses apathy in behavioral, cognitive and emotional domains over the previous four weeks.
1 secondary outcome
Trials making test
Time frame: 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2016.
- Derived from this study: PubMed 29331848Padala PR, Padala KP, Lensing SY, Jackson AN, Hunter CR, Parkes CM, Dennis RA, Bopp MM, Caceda R, Mennemeier MS, Roberson PK, Sullivan DH. Repetitive transcranial magnetic stimulation for apathy in mild cognitive impairment: A double-blind, randomized, sham-controlled, cross-over pilot study. Psychiatry Res. 2018 Mar;261:312-318. doi: 10.1016/j.psychres.2017.12.063. Epub 2018 Jan 5.
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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.
Prasad R Padala, MD, MS principal investigator
Central Arkansas Veterans Healthcare System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Neurostar repetitive transcranial magnetic stimulator in people with Apathy and Mild Cognitive Impairment, run by Central Arkansas Veterans Healthcare System at 1 site in United States.
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 6 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 10 Feb 2016. 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 United States. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
Apathy Evaluation Scale (AES) (time frame: 8 weeks). 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 NCT02190019, which also lists 1 linked publication.
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 10 Feb 2016.