Huntington DiseaseNCT04429230
Non-invasive Brain Stimulation in Huntington's Disease
A study testing Active Transcranial pulsed current stimulation (tPCS) in people with Huntington Disease, run by Western University, Canada.
Trial summary
Huntington's disease is a disabling neurodegenerative disease. Patients present with involuntary movements of the body and cognitive symptoms like behavioral problem, difficulty in planning tasks, etc. No effective treatment is currently available for them apart from symptomatic therapy. Read more about this study
- Who is it for?
- Ages 15 to 75 years
- Conditions the study is for
- Huntington Disease
- What is being tested?
- Active Transcranial pulsed current stimulation (tPCS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 15 participants
- Where
- No sites listed yet
- Study dates
- 7 Sep 2021to 31 Dec 2022
- 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 15 to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients of Huntington's disease diagnosed clinically or genetically proved
Who cannot join
- • Patients who can't walk even with support, like wheel chair bound patients.
- Patients having other issues like stroke that can aggravate speech/ gait.
- Patients who are not able to provide informed consent.
- Patients who are unable to communicate by speech and who can't comprehend the English language.
Trial locations and contacts
No sites are listed yet.
Jacky Ganguly contact
About this study
Official title: A Trial of Non-invasive Brain Stimulation in Huntington's Disease
Huntington's disease is a disabling neurodegenerative disease. Patients present with involuntary movements of the body and cognitive symptoms like behavioral problem, difficulty in planning tasks, etc. No effective treatment is currently available for them apart from symptomatic therapy. Currently, studies are going on the effectiveness of noninvasive brain stimulation (NIBS) in neurodegenerative diseases. It is a mode of brain stimulation technique where current is delivered into the brain by placing electrodes into their scalp. Transcranial pulsed current stimulation (tPCS) is a new modality of noninvasive brain stimulation. It is a device that generates electrical impulses. The current generated from this device can stimulate underlying brain areas. The investigators have planned to study the feasibility of non-invasive brain stimulation via tPCS in these patients of Huntington's disease.
At first, the investigators will rate their involuntary body movement by a standard scale, assess arm movements by a robotic device, assess speech with standard protocol, assess brain electrophysiology by electroencephalography (EEG) and will also do gait (walking) analysis. Next, the investigators will give them 2 week (20 min/day) stimulation via real tPCS (active stimulation) or placebo (sham stimulation). After 2 weeks of stimulation, the investigators will re-assess the patient using the same tools mentioned pre-stimulation.
Each patient will receive real and placebo stimulation with a 1-month gap in between. They will not know whether they are receiving real stimulation or placebo. Assessment will be done before stimulation, after 2 week real stimulation and after 2 week sham stimulation.
Read the detailed description
The investigators have planned to study the feasibility of non-invasive brain stimulation via Transcranial pulsed current stimulation (tPCS) in patients of Huntington's disease. Anodal stimulation will be given to the brain area based on quantitative electroencephalography (qEEG) findings.
Patients will be assessed clinically by standard rating scale (UHDRS) and by qEEG, KinArm and Gait - before and after 2 week (20 min per day) stimulation via tPCS or sham stimulation.
The investigators have planned to assess-
- Speech
- Upper limb movement via KinArm. Standard KinArm testing protocol will be used which is used universally.
- Gait via Gait Carpet (Zeno Walkway)
- Quantitative electroencephalography (qEEG)
- Scale for Huntington's disease (UHDRS) tPCS will be delivered through a pair of saline-soaked (0.9% NaCl) surface sponge electrodes. Anode will be placed on the scalp over the area based on qEEG findings. Participant's speech will be recorded using a head-mounted microphone (AKGc520) and a digital recording device (Zoom H4nPro) while performing the following calibrated tasks (Calibration involves a sound level meter placed at 15cm from the mouth while talker says 'ah' at 70dBA) - a. Prolonged 'ah'. b. Rapid repetitions of the sounds "puh", "tuh", and "kuh". c. Two productions of a sentence with selected speech sounds (s, sh, p, b, t, i, a, u, ae, ai). "She saw Patty buy two poppies." d. Two times louder production of a sentence with selected speech sounds. "She saw Patty buy two poppies." e. Repetition of a continuous vowel at normal and fast rates. 'eye-eye-eyeeye- eye' without making any voice breaks or pauses". f. Read aloud a section of a standard passage - standard rainbow passage g. Monologue. Talk for two minutes about an interesting vacation (or an interesting hobby or activity). The Zeno walkway will be used in conjunction with the ProtoKinetics Movement Analysis Software (PKMAS) . The walkway contains a series of pressure sensors to detect footfalls. These data will be captured and collated via the PKMAS software, resulting in numerous spatial, temporal and pressure-related gait parameters. Timed-up-and-go (TUG) task will be used, consisting of rising from chair, walking across the 20-foot gait carpet, turning around off the carpet, walking back and sitting down. This will be performed over 3 trials. Gait analysis provides various parameters as output such as stride length, line of progression, step length, toe-offs and other temporal and spatial parameters for analysis. Neurophysiological EEG signals will be recorded, eyes-closed, no-task, using g.Nautilus g.tec wireless system. The g.tech system uses earclip reference sensors. The subject will be in a quiet place with less light or electromagnetic perturbations. During the resting state recordings, patients are seated in a comfortable arm chair and will be instructed to keep relaxed, with their eyes closed for 5 min. A paired t test will be used to compare baseline data and post tPCS data. Descriptive analysis of the neurological examination findings will be provided.
- Conditions
- Huntington Disease
- Being tested
- Active Transcranial pulsed current stimulation (tPCS), Sham Transcranial pulsed current stimulation (tPCS)
- Medical subject headings
- Huntington Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active Transcranial pulsed current stimulation (tPCS)Device
Active tPCS will be delivered through a pair of saline soaked (0.9% NaCl) surface sponge electrodes. Anodal stimulation will be given to brain area based on qEEG findings
Sham Transcranial pulsed current stimulation (tPCS)Device
Electrode placement will be the same as active stimulation but the electric current will be ramped down 5 seconds after the beginning of the stimulation to make this condition indistinguishable from the experimental active stimulation.
| Study group | Role | What they receive |
|---|---|---|
| Real tPCS | Active comparator | Patients of Huntington's disease will be randomly allocated into both the arms. Real tPCS arm will receive active tPCS. Then they will be crossed over to Sham tPCS arm. Receives: Device: Active Transcranial pulsed current stimulation (tPCS) |
| Sham tPCS | Sham comparator | Patients of Huntington's disease will be randomly allocated into both the arms. Sham tPCS arm will receive sham tPCS. Then they will be crossed over to Real tPCS arm. Receives: Device: Sham Transcranial pulsed current stimulation (tPCS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of recruitment
Can we recruit 15 HD patients for non-invasive brain stimulation study
Measured: 1 year
Feasibility of finishing the study
Can 15 participants finish the study
Measured: 1 year
Feasibility of home based stimulation
Can non-invasive brain stimulation in the form of transcranial pulsed current stimulation (tPCS) be appropriately applied at home
Measured: 1 year
Feasibility of network targeting
Can dysfunctional brain area in HD be targeted for stimulation non-invasively, using qEEG as a guide
Measured: 1 year
Secondary outcomes (5)
Change in UHDRS
The investigators will evaluate the effectiveness of tPCS in patients of Huntington's disease. The investigators will apply Unified Huntington's disease rating scale (UHDRS) pre and post stimulation. The scale is for assessment of chorea, dystonia, ataxia, extraocular movements, speech, gait, postural imbalance. Each subsection can be scored from 0-4. By summing up, the total score ranges from minimum 0 and maximum 124. Higher score means more severity.
Measured: 3 months
Changes in spatiotemporal gait measures using objective gait analysis
The investigators will use Zeno Walkway Gait carpet and the spatiotemporal details of the gait will be analyzed by ProtoKinetics Movement Analysis Software (PKMAS) software, pre and post stimulation.The Zeno walkway will be used in conjunction with the ProtoKinetics Movement Analysis Software (PKMAS). The walkway contains a series of pressure sensors to detect footfalls. These data will be captured and collated via the PKMAS software, resulting in numerous spatial, temporal and pressure-related gait parameters. Timed-up-and-go (TUG) task will be used, consisting of rising from chair, walking across the 20-foot gait carpet, turning around off the carpet, walking back and sitting down.
Measured: 3 months
Change in upper limb movements
The investigators will use KinArm pre and post stimulation to have objective measurement of upper limb movements. KinArm is a robotic manipulator arm. The patients will hold the manipulator arm and move it across to certain points shown on the computer screen. The investigators will use standard KinArm testing protocols to assess upper limb movements.
Measured: 3 months
Change in speech
The investigators will use standardized speech protocol pre and post stimulation to assess speech. Participant's speech will be recorded using a head-mounted microphone (AKG-c520) and a digital recording device (Zoom H4nPro) while performing the following calibrated tasks. Calibration involves a sound level meter placed at 15cm from the mouth while talker says 'ah' at 70dBA. The following speech tasks will be assessed- Prolonged phonation, Rapid repetitions of the sounds, Two productions of a sentence with selected speech sounds, Two times louder production of a sentence with selected speech sounds, Repetition of a continuous vowel at normal and fast rates without making any voice breaks or pauses.
- Read aloud a section of a standard passage - standard rainbow passage g) Monologue. Talk for two minutes about an interesting vacation (or an interesting hobby or activity).
Measured: 3 months
Changes in Network fragmentation using Quantitative EEG
The investigators will do network fragmentation by 5 mins of resting quantitative Electroencephalography (EEG), pre and post stimulation.Quantitative EEG signals will be recorded using g. Nautilus g.tec wireless system. The g. tech system uses ear clip reference sensors. Patient will sit in a comfortable arm chair in a quiet place with less light or electromagnetic perturbations. The patient will be instructed to sit relaxed with eyes closed for 5 min.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2020
- Study start7 Sep 2021 (estimated)
- Primary completion1 Sep 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
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 Huntington DiseaseStudies of the same condition, open and under way.
- More trials run by Western University, CanadaThe 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
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Western University, Canada
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mandar Jog, Western University, Canada
- Investigators
- Mandar S Jog, Principal investigator, London Health Sciences Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04429230
- Sponsor's protocol ID
- 115632
- Status last verified
- Aug 2021
- First submitted
- 2 Mar 2020
- Last updated
- 8 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Eddy CM, Shapiro K, Clouter A, Hansen PC, Rickards HE. Transcranial direct current stimulation can enhance working memory in Huntington's disease. Prog Neuropsychopharmacol Biol Psychiatry. 2017 Jul 3;77:75-82. doi: 10.1016/j.pnpbp.2017.04.002. Epub 2017 Apr 5.
PubMed 28390970Berardelli A, Suppa A. Noninvasive brain stimulation in Huntington's disease. Handb Clin Neurol. 2013;116:555-60. doi: 10.1016/B978-0-444-53497-2.00044-9.
PubMed 24112923
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Trial of Non-invasive Brain Stimulation in Huntington's Disease
- ClinicalTrials.gov ID
- NCT04429230
- Acronym / sponsor ID
- 115632
- Conditions
- Huntington Disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Western University, CanadaUniversity, hospital or other
- Study start
- 7 Sep 2021 (estimated)
- Primary completion
- 1 Sep 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 12 Jun 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.
Huntington's disease is a disabling neurodegenerative disease. Patients present with involuntary movements of the body and cognitive symptoms like behavioral problem, difficulty in planning tasks, etc. No effective treatment is currently available for them apart from symptomatic therapy. Currently, studies are going on the effectiveness of noninvasive brain stimulation (NIBS) in neurodegenerative diseases. It is a mode of brain stimulation technique where current is delivered into the brain by placing electrodes into their scalp. Transcranial pulsed current stimulation (tPCS) is a new modality of noninvasive brain stimulation. It is a device that generates electrical impulses. The current generated from this device can stimulate underlying brain areas. The investigators have planned to study the feasibility of non-invasive brain stimulation via tPCS in these patients of Huntington's disease.
At first, the investigators will rate their involuntary body movement by a standard scale, assess arm movements by a robotic device, assess speech with standard protocol, assess brain electrophysiology by electroencephalography (EEG) and will also do gait (walking) analysis. Next, the investigators will give them 2 week (20 min/day) stimulation via real tPCS (active stimulation) or placebo (sham stimulation). After 2 weeks of stimulation, the investigators will re-assess the patient using the same tools mentioned pre-stimulation.
Each patient will receive real and placebo stimulation with a 1-month gap in between. They will not know whether they are receiving real stimulation or placebo. Assessment will be done before stimulation, after 2 week real stimulation and after 2 week sham stimulation.
Detailed description
The investigators have planned to study the feasibility of non-invasive brain stimulation via Transcranial pulsed current stimulation (tPCS) in patients of Huntington's disease. Anodal stimulation will be given to the brain area based on quantitative electroencephalography (qEEG) findings.
Patients will be assessed clinically by standard rating scale (UHDRS) and by qEEG, KinArm and Gait - before and after 2 week (20 min per day) stimulation via tPCS or sham stimulation.
The investigators have planned to assess-
- Speech
- Upper limb movement via KinArm. Standard KinArm testing protocol will be used which is used universally.
- Gait via Gait Carpet (Zeno Walkway)
- Quantitative electroencephalography (qEEG)
- Scale for Huntington's disease (UHDRS) tPCS will be delivered through a pair of saline-soaked (0.9% NaCl) surface sponge electrodes. Anode will be placed on the scalp over the area based on qEEG findings. Participant's speech will be recorded using a head-mounted microphone (AKGc520) and a digital recording device (Zoom H4nPro) while performing the following calibrated tasks (Calibration involves a sound level meter placed at 15cm from the mouth while talker says 'ah' at 70dBA) - a. Prolonged 'ah'. b. Rapid repetitions of the sounds "puh", "tuh", and "kuh". c. Two productions of a sentence with selected speech sounds (s, sh, p, b, t, i, a, u, ae, ai). "She saw Patty buy two poppies." d. Two times louder production of a sentence with selected speech sounds. "She saw Patty buy two poppies." e. Repetition of a continuous vowel at normal and fast rates. 'eye-eye-eyeeye- eye' without making any voice breaks or pauses". f. Read aloud a section of a standard passage - standard rainbow passage g. Monologue. Talk for two minutes about an interesting vacation (or an interesting hobby or activity). The Zeno walkway will be used in conjunction with the ProtoKinetics Movement Analysis Software (PKMAS) . The walkway contains a series of pressure sensors to detect footfalls. These data will be captured and collated via the PKMAS software, resulting in numerous spatial, temporal and pressure-related gait parameters. Timed-up-and-go (TUG) task will be used, consisting of rising from chair, walking across the 20-foot gait carpet, turning around off the carpet, walking back and sitting down. This will be performed over 3 trials. Gait analysis provides various parameters as output such as stride length, line of progression, step length, toe-offs and other temporal and spatial parameters for analysis. Neurophysiological EEG signals will be recorded, eyes-closed, no-task, using g.Nautilus g.tec wireless system. The g.tech system uses earclip reference sensors. The subject will be in a quiet place with less light or electromagnetic perturbations. During the resting state recordings, patients are seated in a comfortable arm chair and will be instructed to keep relaxed, with their eyes closed for 5 min. A paired t test will be used to compare baseline data and post tPCS data. Descriptive analysis of the neurological examination findings will be provided.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Real tPCS | Active comparator | Device: Active Transcranial pulsed current stimulation (tPCS)Patients of Huntington's disease will be randomly allocated into both the arms. Real tPCS arm will receive active tPCS. Then they will be crossed over to Sham tPCS arm. |
| Sham tPCS | Sham comparator | Device: Sham Transcranial pulsed current stimulation (tPCS)Patients of Huntington's disease will be randomly allocated into both the arms. Sham tPCS arm will receive sham tPCS. Then they will be crossed over to Real tPCS arm. |
Who may qualify
- Ages
- 15 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patients of Huntington's disease diagnosed clinically or genetically proved
Key exclusion criteria (4 listed)
- • Patients who can't walk even with support, like wheel chair bound patients.
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 |
|---|---|---|
| Active Transcranial pulsed current stimulation (tPCS)Active tPCS will be delivered through a pair of saline soaked (0.9% NaCl) surface sponge electrodes. Anodal stimulation will be given to brain area based on qEEG findings | Device | Real tPCS |
| Sham Transcranial pulsed current stimulation (tPCS)Electrode placement will be the same as active stimulation but the electric current will be ramped down 5 seconds after the beginning of the stimulation to make this condition indistinguishable from the experimental active stimulation. | Device | Sham tPCS |
Primary outcome
Feasibility of recruitment
Time frame: 1 year
Can we recruit 15 HD patients for non-invasive brain stimulation study
Feasibility of finishing the study
Time frame: 1 year
Can 15 participants finish the study
Feasibility of home based stimulation
Time frame: 1 year
Can non-invasive brain stimulation in the form of transcranial pulsed current stimulation (tPCS) be appropriately applied at home
Feasibility of network targeting
Time frame: 1 year
Can dysfunctional brain area in HD be targeted for stimulation non-invasively, using qEEG as a guide
5 secondary outcomes
Change in UHDRS
Time frame: 3 months
Changes in spatiotemporal gait measures using objective gait analysis
Time frame: 3 months
Change in upper limb movements
Time frame: 3 months
Change in speech
Time frame: 3 months
Changes in Network fragmentation using Quantitative EEG
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2021.
- Background: PubMed 28390970Eddy CM, Shapiro K, Clouter A, Hansen PC, Rickards HE. Transcranial direct current stimulation can enhance working memory in Huntington's disease. Prog Neuropsychopharmacol Biol Psychiatry. 2017 Jul 3;77:75-82. doi: 10.1016/j.pnpbp.2017.04.002. Epub 2017 Apr 5.
- Background: PubMed 24112923Berardelli A, Suppa A. Noninvasive brain stimulation in Huntington's disease. Handb Clin Neurol. 2013;116:555-60. doi: 10.1016/B978-0-444-53497-2.00044-9.
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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.
Jacky Ganguly contact
Mandar S Jog principal investigator
London Health Sciences Centre
Questions about this trial
What is this clinical trial studying?
A study testing Active Transcranial pulsed current stimulation (tPCS) in people with Huntington Disease, run by Western University, 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 1 inclusion and 4 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 8 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mandar S Jog (5196676708 ext. 3814, Mandar.Jog@lhsc.on.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of recruitment (time frame: 1 year). The study lists 4 primary outcomes in all. 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 NCT04429230, 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 8 Sep 2021.