NCT06015672

Brief Summary

This study aims to investigate the impact of accelerated transcranial magnetic stimulation (TMS) on brain function and behavior in patients with focal hand dystonia. Previous research demonstrated that individualized TMS improved dystonic behavior after one session. Building on this, the current study administers four TMS sessions in a day, with assessments conducted in four weeks, twelve weeks, and 20 weeks after each session. The research involves 8 in-person and 6 virtual visits focused on functional MRI brain scans and writing behavior analysis. The potential risk of seizures from TMS is mitigated through careful screening, adhering to safety guidelines. The study's main benefit is enhancing dystonic behavior and deepening the understanding of brain changes caused by TMS in focal hand dystonia, paving the way for further advancements in clinical therapy for this condition.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
21

participants targeted

Target at below P25 for not_applicable

Timeline
9mo left

Started Dec 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress76%
Dec 2023Feb 2027

First Submitted

Initial submission to the registry

August 23, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 29, 2023

Completed
4 months until next milestone

Study Start

First participant enrolled

December 21, 2023

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 5, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 5, 2027

Last Updated

March 11, 2026

Status Verified

February 1, 2026

Enrollment Period

3.1 years

First QC Date

August 23, 2023

Last Update Submit

March 9, 2026

Conditions

Isolated Focal Hand Dystonia

Outcome Measures

Primary Outcomes (2)

  • Change in behavioral writing measure

    Using change in peak accelerations to assess writing behavior

    Baseline, 4 weeks, 12 weeks, 20 weeks, 24, weeks, 32 weeks and 40 weeks

  • Change in brain connectivity in the motor network

    Using functional magnetic resonance imaging of the brain

    Baseline, 12 weeks, 20 weeks and 32 weeks

Study Arms (2)

TMS to primary somatosensory cortex

ACTIVE COMPARATOR

Participants received TMS sessions at primary somatosensory cortex

Device: Transcranial Magnetic Stimulation (TMS)

TMS at low amplitude to primary somatosensory cortex

SHAM COMPARATOR

Participants receive TMS at a cortical target at smaller amplitude

Device: Transcranial Magnetic Stimulation (TMS)

Interventions

Transcranial Magnetic Stimulation (TMS)DEVICE

Participants will have two accelerated transcranial magnetic stimulation (TMS) visits. Each TMS visit will be separated by 5 months. During each TMS visit, they will receive four TMS sessions, each separated by 60 minutes of rest.

TMS at low amplitude to primary somatosensory cortexTMS to primary somatosensory cortex

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • yrs and older
  • Diagnosed with isolated focal hand by Neurologist
  • Right-hand dominant
  • Must be able to sign an informed consent
  • Must be literate

You may not qualify if:

  • Other neurological movement disorders diagnoses including other types of dystonia, Parkinsonism, or essential tremor
  • History of seizure disorder
  • Concomitant medications are known to decrease seizure threshold
  • Illicit drug use
  • No TMS therapy for another indication within one month of this research study
  • Botulinum toxin injections within 3months of the research study
  • Medications used for symptom treatment of dystonia including anticholinergic, benzodiazepines, and muscle relaxants among others within one month of the study
  • No physical or occupational therapy of the hand within one month of the study
  • Any contraindications to MRI or TMS

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Duke University Health System

Durham, North Carolina, 27705, United States

Location

Related Publications (4)

  • Noreen Bukhari-Parlakturk, Patrick Mulcahey, Michael Lutz, Rabia Ghazi, Ziping Huang, Moritz Dannhauer, Zeynep Simsek, Skylar Groves, Mikaela Lipp, Michael Fei, Tiffany Tran, Eleanor Wood, Lysianne Beynel, Burton Scott, Pichet Termsarasab, Chris Petty, Hussein R Al-Khalidi, James Voyvodic, Lawrence G. Appelbaum, Simon Davis, Andrew Michael, Angel Peterchev, Nicole Calakos. "Functional MRI-guided individualized TMS modifies motor network and reduces writing dysfluency in Focal Hand Dystonia." Human Brain Mapping Conference. Montreal, Canada. July 22-26, 2023. virtual poster presentation.

    BACKGROUND

  • Noreen Bukhari-Parlakturk, Patrick Mulcahey, Michael Lutz, Rabia Ghazi, Ziping Huang, Moritz Dannhauer, Zeynep Simsek, Skylar Groves, Mikaela Lipp, Michael Fei, Tiffany Tran, Eleanor Wood, Lysianne Beynel, Burton Scott, Pichet Termsarasab, Chris Petty, Hussein R Al-Khalidi, James Voyvodic, Lawrence G. Appelbaum, Simon Davis, Andrew Michael, Angel Peterchev, Nicole Calakos. "Functional MRI-guided individualized TMS modifies motor network and reduces writing dysfluency in Focal Hand Dystonia." Samuel Belzberg 6th International Dystonia Symposium. Dublin, Ireland. June 1-3, 2023. poster presentation.

    BACKGROUND

  • Bukhari-Parlakturk N, Lutz MW, Al-Khalidi HR, Unnithan S, Wang JE, Scott B, Termsarasab P, Appelbaum LG, Calakos N. Suitability of Automated Writing Measures for Clinical Trial Outcome in Writer's Cramp. Mov Disord. 2023 Jan;38(1):123-132. doi: 10.1002/mds.29237. Epub 2022 Oct 13.

    PMID: 36226903BACKGROUND

  • Dannhauer M, Huang Z, Beynel L, Wood E, Bukhari-Parlakturk N, Peterchev AV. TAP: targeting and analysis pipeline for optimization and verification of coil placement in transcranial magnetic stimulation. J Neural Eng. 2022 Apr 21;19(2):10.1088/1741-2552/ac63a4. doi: 10.1088/1741-2552/ac63a4.

    PMID: 35377345BACKGROUND

MeSH Terms

Interventions

Transcranial Magnetic Stimulation

Intervention Hierarchy (Ancestors)

Magnetic Field TherapyTherapeutics

Study Officials

  • Noreen Bukhari-Parlakturk, MD PhD

    Duke Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
The TMS intensity delivered at each TMS visit will be masked
Purpose
TREATMENT
Intervention Model
CROSSOVER
Model Details: Double-arm crossover study design with subjects receiving TMS at two different intensities
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 23, 2023

First Posted

August 29, 2023

Study Start

December 21, 2023

Primary Completion (Estimated)

February 5, 2027

Study Completion (Estimated)

February 5, 2027

Last Updated

March 11, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)