| CTRI Number |
CTRI/2025/12/098484 [Registered on: 04/12/2025] Trial Registered Prospectively |
| Last Modified On: |
02/12/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Transcranial magnetic stimulation ] |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Magnetic stimulation of the Brain for treating walking and thinking problems in PSP (Progressive Supranuclear Palsy). |
|
Scientific Title of Study
|
Blinded Randomized Controlled Trial of rTMS to the Dorsolateral Prefrontal Cortex in Progressive Supranuclear Palsy: Effects on Gait, Cognition, and Brain Perfusion |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Yaranagula Sai Deepak |
| Designation |
Director, Parkinsons and Movement Disorders Clinic (PMDC), Citi Neuro Centre |
| Affiliation |
Citi Neuro Centre |
| Address |
Room 7, B3, PMDC, Dept of Neurology, Citi Neuro Centre, Number 12, Banjara Hills, Hyderabad, Telangana
Hyderabad TELANGANA 500028 India |
| Phone |
9591865402 |
| Fax |
|
| Email |
sd1162010@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Yaranagula Sai Deepak |
| Designation |
Director, Parkinsons and Movement Disorders Clinic (PMDC), Citi Neuro Centre |
| Affiliation |
Citi Neuro Centre |
| Address |
Room 7, B3, PMDC, Dept of Neurology, Citi Neuro Centre, Number 12, Banjara Hills, Hyderabad, Telangana
Hyderabad TELANGANA 500028 India |
| Phone |
9591865402 |
| Fax |
|
| Email |
sd1162010@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Yaranagula Sai Deepak |
| Designation |
Director, Parkinsons and Movement Disorders Clinic (PMDC), Citi Neuro Centre |
| Affiliation |
Citi Neuro Centre |
| Address |
Room 7, B3, PMDC, Dept of Neurology, Citi Neuro Centre, Number 12, Banjara Hills, Hyderabad, Telangana
Hyderabad TELANGANA 500028 India |
| Phone |
9591865402 |
| Fax |
|
| Email |
sd1162010@gmail.com |
|
|
Source of Monetary or Material Support
|
| Citi Neuro Centre Foundation, Citi Neuro Centre, Number 12, near Shri Jagannath Temple, MLA Colony, Banjara Hills, Hyderabad, Telangana 500028 |
|
|
Primary Sponsor
|
| Name |
Citi Neuro Centre Foundation |
| Address |
Citi Neuro Centre, Number 12, near Shri Jagannath Temple, MLA Colony, Banjara Hills, Hyderabad, Telangana 500028 |
| Type of Sponsor |
Private hospital/clinic |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Yaranagula Sai Deepak |
Citi Neuro Centre |
Number 12, near Shri Jagannath Temple, MLA Colony, Banjara Hills, Hyderabad, Telangana 500028 Hyderabad TELANGANA |
9591865402
sd1162010@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| CNC Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G231||Progressive supranuclear ophthalmoplegia [Steele-Richardson-Olszewski], |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Transcranial Magnetic Stimulation |
rTMS over left dorsolateral prefrontal cortex will be conducted using a high-frequency protocol (10 Hz), applying 60 trains of 50 pulses with a duration of 5 seconds and an intertrain interval of 25 seconds (3,000 pulses per session), at an intensity of 120% of the resting motor threshold. Over the course of 8 weeks, 25 sessions will be scheduled |
| Comparator Agent |
Transcranial Magnetic Stimulation |
Sham Arm: Identical procedure using a sham coil that mimics sensation and sound without active stimulation. |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
-Diagnosis of PSP according to MDS criteria
-Ability to stand unassisted for 30 seconds and able to walk independently
-MMSE 18 or more
-On stable treatment of anticholinergic, dopaminergic, serotonergic or NMDA antagonist medication
-Age 40–80 years
-Able to undergo MRI and rTMS
-Informed consent provided
|
|
| ExclusionCriteria |
| Details |
-Contraindications to rTMS or MRI (e.g., metallic implants)
-Pregnancy
-History of cerebellar ataxia, SOL, hydrocephalus, SDH, Prior vestibular disease
-Sensory deficit in feet
-Epilepsy
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Gait: Change in Time taken to walk 10 meters measured via video gait recording of Timed up and go test (TUG)
Cognition: Changes in Montreal Cognitive Assessment (MoCA) and Frontal assessment battery (FAB) scores |
2 months, 3 months, 4 months and 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
-Change in number of Falls with falls diary
-Change in PSP rating scale
-Changes in Brain perfusion: ASL MRI to assess regional cerebral blood flow changes in relevant cortical and subcortical regions |
4 months |
|
|
Target Sample Size
|
Total Sample Size="100" Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
15/12/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1" Months="0" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol Response - Statistical Analysis Plan Response - Informed Consent Form Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [sd1162010@gmail.com].
- For how long will this data be available start date provided 01-01-2028 and end date provided 31-12-2100?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Repetitive transcranial
magnetic stimulation (rTMS) is a non-invasive brain stimulation technique shown
to be useful in treating a number of neuropsychiatric conditions including
depression, neuropathic pain and Parkinson’s disease (PD). While in
depression, rTMS is being increasingly used, its use in Parkinsonian
syndromes has been impeded by lack of high-quality evidence. A few studies have
explored rTMS in PD and atypical Parkinsonian syndromes such as
Progressive supranuclear palsy (PSP). However, most studies are limited by
small samples, inadequate dosage of intervention and lack of patho-physiological
study correlates.
The use of rTMS in
depression has gained widespread attention and acceptance. The runaway
success of rTMS in major depressive disorder (MDD) is rooted in a firm
biological basis with the dorsolateral prefrontal cortex (DLPFC) at its heart. In
MDD, the left DLPFC is hypoactive and right DLPFC is hyperactive. Therefore,
logic dictates that improvement in activity of left DLPFC or inhibition of
right DLPFC activity would be able to reverse depression. rTMS is capable of
neuro stimulation at high frequency and inhibition at low frequency. Taken
together, rTMS is a convenient non-invasive tool that has tremendous potential
to modulate neural circuits in depression and this has been applied by multiple
researchers.
DLPFC, especially the
left DLPFC, is a large specialized area of the prefrontal cortex with a
significant role in maintaining working memory. Working memory is the
ability to hold information online for a few seconds to minutes. This
is essential to keep track of ongoing activity, the components of activity that
have been executed and the pending components that have to be executed in order
to complete a task. Working memory research has been predominantly focused
on specific sensory modalities such as visuospatial (visual) working memory or
phonological (verbal) working memory. Recent research has shown evidence to
suggest existence of motor working memory along similar lines. Deficits in
working memory have been shown to be associated with increased falls in elderly. This is an important realization as interventions improving cognition may
improve falls and gait.
In general, older
adults demonstrate relative hyperactivity of brain during a given task when
compared to younger individuals. This is thought to be a compensatory
phenomenon as older brains recruit additional brain regions to compensate for
age related degeneration. The left DLPFC plays an important role in gait. In elderly, there is a relative hyperactivity of left DLPFC during
walking. By corollary, dysfunction of DLPFC can therefore lead to
abnormalities in walking and gait, and by extension can lead to increased risk
of falls.
In PSP, there is
evidence to suggest dysfunction of left DLPFC. A recent study evaluated the
effects of transcranial direct current stimulation (tDCS) over left DLPFC in
PSP and found it to be ineffective in improving cognitive and motor functions.
However, the study was severely limited with only 16 subjects receiving real
tDCS for only 5 days per week for 2 weeks. While there have been rTMS
studies on gait in PSP, none of them evaluated DLPFC stimulation. Both
these studies were limited by small sample size and limited rTMS dosage.
Therefore, a sufficiently powered study with appropriate sample size and
appropriate rTMS dosage on DLPFC in PSP is lacking. This study aims to assess
the efficacy of DLPFC rTMS in improving gait and cognition, and to evaluate
associated changes in cerebral perfusion using arterial spin labeling (ASL) MRI
in PSP patients. |